CHAMGAP

Vitamin C (L-ascorbic acid) × Isotope-measured fractional iron absorption in nonanemic women with low iron stores

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Required evidence, verification status and materials actually read
ItemAVerification statusBReading scopeCReview itemDCurrent findingsEWhy unverifiedFRequired materials and conditionsGFurther research
1 Met Full text not readStored summary read N01 · Independent questionWhich iron absorption comparison does this table address?Required
The original claim is ‘isotope-measured fractional iron absorption in nonanemic women with low iron stores.’ It compares addition of 80 mg of single-ingredient L-ascorbic acid with an identical fasted oral iron-and-water control. Anemia treatment, fatigue, vitality and Hb recovery in 907 are separate questions.
The identity of the question and its exclusion boundaries have been linked to the current manuscript. This does not mean that a clinical treatment effect or suitability for an individual's use has been verified.
Identity of the question: nonanemic women with low iron stores, oral single-ingredient L-ascorbic acid, an identical-iron comparator and isotope-measured fractional iron absorption
Cross-check the original claim, population, exposure, comparator and endpoint to document included/excluded questions and the different Hb endpoint in 907.
2 Met Full text not readStored summary read N02 · Main trial identityTo which article is the main absorption result attributed?Required
S01 is the 2023 Am J Hematol article by von Siebenthal and colleagues. The PubMed identity in S02 has the same DOI and PMID. The current main-trial summary is attributed to Methods 2.1–2.5 and Results 3/Figure 2A in S01.
The bibliography and attribution of the main-trial summary agree within the current stored summary. The external publisher site and PubMed were not opened this time.
Link between the stored summary and the title, DOI, PMID and Methods/Results locations of the von Siebenthal 2023 article
Cross-check the article identity and citation locations, keeping the roles of other outcomes/cited reports separate.
3 Partly verified Full text not readStored summary read N03 · Report familyAre the 22 bibliographic entries being kept distinct from independent absorption trials?Required
There are 22 bibliographic entries: S01–S21 and P907. S01/S02/S03 belong to the same article family: main text, index and supplementary material. S17 reflects a historical inference that it is probably the registration for the same trial. The 1 directly eligible family in the original evidence_status reflects the verification scope at that time; other bibliographic entries are not added as independent direct trials.
The same-article family and material types have been distinguished. The official link for S17 and the complete identities of unique cohorts in other reports cannot be established from the current input alone.
The same-article relationship of S01/S02/S03, the provisional registration link in S17 and the roles of each related article, official explanatory source, registration and 907
Cross-check the DOI, registration, population/schedule and included-trial tables across all reports to audit family duplication and unverified relationships.
4 Met Full text not readStored summary read N04 · Reading scopeHave materials actually read now been distinguished from full texts read in the past?Required
The current retained KO 16 fields, structured evidence, 22 bibliographic entries, assessment and gap/correction records were read. The original assessment records past verification of the full S01 HTML and official index/safety materials. The content referenced in sources.json, the old ZIP and external materials were not opened this time; all external material types remain unread.
Actual summary reading has been distinguished from past full-text/partial access and current access not attempted. No new verification of full-text content is claimed.
Sections, bibliography and dates actually read in the current source's stored summary; historical HTML/index/mirror/failure records; and current status by external material type
Audit the current input scope and the access/acquisition/reading history by material type, and update separately only when an actual new reading event occurs.
5 Partly verified Full text not readStored summary read N05 · Selected populationWhat were the actual population's iron stores, anemia status and selection criteria?Required
The population comprises nonpregnant, nonlactating women aged 18–45 years with ferritin ≤30 μg/L, Hb >12 g/dL and CRP <5 mg/L. The retained criteria also specify BMI 18.5–26.5 kg/m², body weight <70 kg and no major chronic disease. This is not classified as a treatment trial in women with anemia.
The claim's population has been linked to the retained selection criteria. Verification against original data remains outstanding for actual baseline distributions, recruitment representativeness and differences from the registration criteria.
Criteria for the women's age, pregnancy/lactation, ferritin, Hb, CRP, BMI, weight and disease status, together with baseline characteristics/selection flow
Cross-check inclusion/exclusion criteria, the baseline-characteristics table and recruitment flow to examine the actual analyzed population and scope of generalization.
6 Unverified Full text not readStored summary read N06 · Baseline nutritional statusCan this be interpreted as an effect of correcting vitamin C deficiency or of the habitual diet?Required
Baseline vitamin C status, habitual diet and total vitamin C intake are recorded as not reported in the stored summary. The current trial is not classified as a trial of vitamin C deficiency correction.
The current input has no actual baseline test/intake values, so deficiency status and total exposure cannot be established. This does not constitute new verification that reporting is absent from the entire external full text.
Baseline vitamin C testing, habitual diet/total intake and whether deficiency was a selection criterion
Cross-check baseline nutritional testing, dietary records and intake by condition to distinguish deficiency status from the contribution of the added dose.
7 Unverified Full text not readStored summary read N07 · Baseline risk screeningHave selection boundaries relating to iron, renal status and G6PD been verified?Required
Entry criteria for TSAT and renal function, and screening for iron overload and G6PD, remain in unresolved_facets. This unverified information does not justify directly applying risks from high-dose intravenous vitamin C materials to the current oral condition.
Specific screening criteria/results cannot be verified from the current input. No conclusion that the individuals are safe candidates is drawn.
Entry criteria for TSAT and renal function, procedures for iron-overload and G6PD screening, and participant-specific records
Cross-check entry-test tables and exclusion/safety-screening records to examine the actual eligible population and separate vulnerable groups.
8 Partly verified Full text not readStored summary read N08 · Active ingredient identityWhat are the identities of the trial's vitamin C ingredient and product?Required
The added ingredient is food-grade, single-ingredient L-ascorbic acid from Sigma Aldrich. Manufacturing origin, lot and exact purity are recorded as not reported in the stored summary. It is distinguished from sodium/calcium salts, juice and multinutrient products.
The active ingredient and product designation are verified, but manufacturing/batch/purity information remains outstanding. Equivalence to other formulations has not been verified.
Actual manufacturing origin, lot and purity of Sigma Aldrich food-grade, single-ingredient L-ascorbic acid, and its distinction from other formulations
Cross-check product specifications, trial batches and ingredient records to verify a reproducible identity for the active ingredient and formulation.
9 Met Full text not readStored summary read N09 · Route of administrationBy what route and in what prepared form were they administered together?Required
Single-ingredient L-ascorbic acid dissolved in water was administered orally together with iron in the fasted state. The effect size is not transferred to intravenous administration, juice, foods, salts, combination products or other iron formulations.
The criteria for documenting the actual route and excluded formulations are met. This does not verify efficacy of other formulations or safety by route.
Oral coadministration of L-ascorbic acid dissolved in water, distinguished from the iron capsule and meal/juice/intravenous conditions
Cross-check preparation/administration procedures, and design separate questions and direct comparisons when examining other routes/media.
10 Partly verified Full text not readStored summary read N10 · Iron exposure amountHow are the 100 mg capsule and the amount of isotope label distinguished?Required
The same Ferrum Hausmann 100 mg Kaps is reported to contain 100 mg of elemental iron, with an isotope label of 3 mg also reported. The authors' molar ratio of 0.24:1 is preserved. Because the record states that total elemental iron including the label was not presented in a separate table, absolute absorbed iron in mg is not calculated.
The capsule amount, label amount and reported molar ratio have been linked, but the actual total elemental iron amount is unverified. No new addition or calculation of absolute absorption was performed.
The capsule's 100 mg of elemental iron, the reported 3 mg label, the authors' molar ratio of 0.24:1 and explicit information on actual total elemental iron
Cross-check preparation/label masses and the actual total-dose table to distinguish the different estimands for fractional and absolute amounts.
11 Partly verified Full text not readStored summary read N11 · Actual comparatorApart from the added 80 mg, are the iron and water exposures identical in the main comparison?Required
The comparison concerns conditions in which the same participant takes a labeled ferrous fumarate capsule with 200 mL of water. In the main comparison, the difference is whether 80 mg of food-grade L-ascorbic acid is added. Other comparisons among the 6 conditions are not merged with these two conditions.
The retained manuscript explicitly specifies the same iron-and-water comparator. A current cross-check of the original composition table and condition-specific concomitant-treatment/adherence records remains outstanding.
The same participant's exposure to the same labeled iron capsule and 200 mL of water, with or without added ascorbic acid, and actual records of common concomitant treatments
Cross-check the composition/common-treatment table for each dosing condition to audit the actual comparison of interest and differences in concomitant treatments/media.
12 Partly verified Full text not readStored summary read N12 · Fasting and timingWhat were the meal and morning dosing conditions for the absorption comparison?Required
The main comparison concerns simultaneous administration of the same iron and water with vitamin C at 07:00–09:00 in the morning after an overnight fast. An identical effect size with meals has not been verified.
The nominal fasting and timing conditions are preserved. Individual adherence and corresponding effect data for other times/meals have not been cross-checked in the current work.
Procedures for overnight fasting, morning dosing at 07:00–09:00 and simultaneous administration, with actual adherence records by condition
Cross-check meal/administration diaries and observation records, and examine questions about dosing after meals or at different times through separate comparisons.
13 Partly verified Full text not readStored summary read N13 · Exposure and blood-sampling scheduleHave single-exposure absorption measurements been distinguished from the duration of long-term use?Required
Each condition involves exposure 1 time, with crossover dosing on days 1·3·5·22·24·26. According to the Methods section, blood sampling occurs on days 22/43, with label-specific incorporation measured 17–21 days after each dose. The recorded conflict over the final blood-sampling day remains unresolved, and this is not interpreted as an effect of long-term use.
The Methods schedule and single exposure are preserved. The conflict with other records over the final blood-sampling day remains, so the schedule is not promoted to a definitive final schedule.
Dosing days 1·3·5·22·24·26 for the 6 conditions, blood sampling on days 22/43 in the Methods section, incorporation measurements 17–21 days after administration of each label and records of conflicting information
Cross-check dosing/blood-sampling schedules, figures and registration history by date to verify the exposure window and label-specific observation windows.
14 Partly verified Full text not readStored summary read N14 · Allocation and blindingWhat was the actual extent of crossover allocation and blinding?Required
The study is recorded as a randomized, open-label crossover trial with a computer-generated sequence. Allocation concealment and laboratory blinding remain not reported in the retained assessment. The objectivity of the isotope method is not used as evidence that blinding was completed.
The design and sequence generation were reported, but actual information on concealment/laboratory-blinding procedures remains outstanding.
Computer-generated crossover sequence, allocation-concealment/laboratory-blinding/open-label procedures, and baseline/sequence data
Cross-check random-sequence generation, allocation/testing procedures and baseline data by sequence to examine allocation limitations for the selected result.
15 Partly verified Full text not readStored summary read N15 · Participant and observation denominatorsCan 35 participants, 34 participants and 204 observations be distinguished?Required
Of 35 enrolled participants, 34 completed all 6 conditions and were analyzed. The 204 observations are repeated observations, not 204 people. The main comparison uses the same 34 participants, whose counts are not combined as sample sizes for two independent groups.
The retained enrollment, analysis and observation denominators have been distinguished. A current cross-check of the original condition-specific missing-data/analysis flowchart remains outstanding.
35 enrolled participants, 34 analyzed participants who completed the 6 conditions, 204 observations, and linkage of the same participants across the two selected conditions
Cross-check participant flow and condition-specific analysis tables to distinguish denominators for people, repeated observations and pairs.
16 Partly verified Full text not readStored summary read N16 · Analysis and attritionHave the completer analysis, withdrawal and imputation records been distinguished?Required
This is a per-protocol completer analysis; 1 of the 35 participants withdrew after the first visit because of difficulty maintaining the fast. The condition involved is unverified. CRP imputation in the retained assessment is a separate record from imputation of fractional iron absorption.
The reason for attrition and the analysis/imputation boundaries are preserved. The condition of withdrawal, original details of missing-data handling and analysis of all randomized participants are unverified.
Reason/condition for the 1 withdrawal after the first visit, the per-protocol completer analysis, and separate handling of CRP imputation and missing FIA data
Cross-check the flow diagram, missing-data/imputation rules and analysis code to examine the distinction between effects of assignment and adherence, and the possible influence of attrition.
17 Unverified Full text not readStored summary read N17 · Handling of the crossover designHow were adherence and period, sequence and carryover effects handled?Required
Supervised administration is recorded, but interactions involving period, sequence and carryover effects remain in unresolved_facets. A comparison within the same participants is distinguished from estimation of an adjusted crossover effect.
Supervised administration alone cannot establish the actual model contrasts or handling of sequence/carryover.
Records of supervised administration, period/sequence/carryover effects and interactions, and definitions of the actual crossover model and contrast
Cross-check administration logs, the repeated-measures model, period/sequence terms and prespecified contrasts to examine the adequacy of the crossover handling.
18 Partly verified Full text not readStored summary read N18 · Isotope measurementWhich test and unit define the fractional iron absorption result?Required
The endpoint is FIA (%) obtained from erythrocyte incorporation of 54Fe·57Fe·58Fe and isotope dilution. The incorporation model uses measurements 17–21 days after administration of each label; blood iron concentration or an increase in Hb is not substituted for absorption.
The assay type, unit and measurement window have been linked. A current cross-check of original assay quality and actual label-specific measurements remains outstanding.
Erythrocyte incorporation of 54Fe·57Fe·58Fe, the dilution method, label-specific measurement windows, the definition of FIA (%) and assay quality
Cross-check isotope assays, label-specific incorporation/dilution procedures and outcome units to examine measurement limitations of the selected endpoint.
19 Partly verified Full text not readStored summary read N19 · Incorporation modelWhat does the assumption of 80% erythrocyte incorporation mean?Required
Fractional iron absorption is modeled assuming 80% erythrocyte incorporation. Actual individual incorporation fractions are unverified. The IAEA methods section in S16 is historical background for the calculation principles; it neither verifies incorporation rates in these participants nor provides independent effect data.
The assumption and methodological source are preserved. Individual incorporation fractions and actual model-sensitivity data have not been verified.
The 80% incorporation assumption used in the absorption calculation, individual incorporation fractions and the relevant location in the IAEA method
Cross-check the absorption model/assumptions against individual incorporation data, and examine interpretation of changes to assumptions through an appropriate prespecified analysis.
20 Unverified Full text not readStored summary read N20 · Prespecified endpoints and multiple comparisonsHave the prespecified hierarchy and analysis plan for the selected absorption comparison been verified?Required
The original evidence concerns 1 main comparison selected for the page from the 6 conditions in the same participants. The official prospective endpoint hierarchy is unverified, and the retained assessment records no adjustment for multiple comparisons. This limitation alone does not establish selective reporting.
The current input lacks an official prior plan/history, so prespecification of the page's comparison and the multiple-comparison plan cannot be cross-checked.
Prespecified primary/secondary comparisons among the 6 conditions, protocol, SAP, registration history, handling of multiple comparisons and records of actual outcome changes
Cross-check initial/revised registrations, the protocol, SAP and actual results for the 6 conditions to verify the endpoint/contrast hierarchy and reasons for changes.
21 Partly verified Full text not readStored summary read N21 · Main absorption observationWhat are the actual medians, IQRs and P for the two conditions?Required
With the added 80 mg, median FIA is 26.7% and the IQR is 19.1–32.6%. Without the addition, it is 20.6%, with an IQR of 12.3–25.5%; P<0.001 for the comparison in the same 34 participants is preserved. The IQR is not a CI.
The stored summary's numbers, direction and denominator have been linked. The original test contrast, paired interval and a current full-text check of the original table/figure remain outstanding.
FIA medians, IQRs and P with/without the added 80 mg in the same 34 participants, with the corresponding table/figure and test contrast
Cross-check the original table/figure and test contrast to verify agreement of the reported medians, distributions, P and analysis denominator.
22 Met Full text not readStored summary read N22 · Historical descriptive arithmeticAs which estimand are 6.1%p, 1.296 and 29.6% preserved?Required
The historical calculation record's median difference of 6.1%p, median ratio of 1.296 and approximately 29.6% higher value are descriptive comparisons of marginal medians. They are not the mean/median of individual changes or an adjusted crossover effect. No calculation was performed this time.
The historical arithmetic's units, estimand and limits of application have been kept distinct and unchanged. No new effect size or paired confidence interval was created.
Historical arithmetic records of differences/ratios of marginal medians, distinguished from individual changes and adjusted crossover effects
Cross-check inputs, units and estimands in the retained calculation record against the original results to distinguish descriptive arithmetic from inferential estimation.
23 Unverified Full text not readStored summary read N23 · Variance and intervalsCan the CI, SD and SE for the exact paired effect be verified?Required
The paired or model-adjusted contrast, CI, SD, SE and exact test statistic are unverified. Fields such as mean_changes, sd_changes, standard_error and interval in the original calculation structure are empty. They are not reconstructed from the IQR and P<0.001, and a planning SD from another study is not used.
The current input lacks the actual variance/interval for this contrast. A significant P alone cannot establish precision or a standardized effect.
The paired/model-adjusted effect, CI, SD, SE, exact test statistic and analysis definition for the selected contrast
Acquire the analysis output, paired data and model SE/CI for the selected contrast, and cross-check them against the original estimand/denominator.
24 Unverified Full text not readStored summary read N24 · Importance and clinical benefitHas the clinical meaning of the FIA difference been verified?Supplementary; required for extension to clinical benefit
The retained manuscript describes the direction of absorption positively, but states that clinical meaning and the exact paired magnitude are unverified. FIA is a physiological surrogate; this result does not establish anemia treatment, Hb recovery or improvement in fatigue or health.
A validated threshold for clinical importance and direct clinical-benefit data for the condition have not been verified. This does not erase the FIA observation or turn it into an effect of 0.
A justified importance threshold for absorption itself, together with separate Hb/anemia/patient-centered outcomes and follow-up data
Examine the basis for absorption's importance and direct clinical outcomes by endpoint, designing a separate long-term clinical comparison if needed.
25 Conflicting information Full text not readStored summary read N25 · Registration identityHow have the article's registration number and the probably matching mirror been distinguished?Required
The record states that the printed NCT04074707 appears to concern a pregnancy study and does not match this population. NCT05414474 was provisionally linked by inference from a mirror as a probable registration with the same 6 conditions, investigators and enrollment. The historical record of inability to access the official history is preserved, without treating it as absence of registration or a confirmed link.
The current input records a population mismatch for the printed registration number and a provisional alternative link. Without a cross-check of the official history, registration identity cannot be marked as resolved.
The printed NCT04074707 and identity of the pregnancy registration, the similar conditions/investigators/enrollment in the NCT05414474 mirror, and official version history
Cross-check the official initial/revised registration history against the population, 6 conditions, investigators and enrollment in the article/mirror to verify the actual link.
26 Conflicting information Full text not readStored summary read N26 · Preservation of discrepanciesHave conflicts involving recruitment, blood sampling, registration criteria and secondary results been preserved?Required
QA04 records preservation of conflicts involving recruitment year, blood-sampling day, registration criteria, coffee P values and the reference median. Because the current stored summary does not contain all original values from both sides, no counterpart year, blood-sampling day, coffee P or median is newly supplied. Blood sampling on days 22/43 in the Methods section is also retained only as that section's record.
The historical conflict records are explicit and unresolved. The counterpart original values have not been reread in the current work, so no new confirmation or resolution of conflicts is claimed.
Pairs of original records for recruitment year, final blood-sampling day, registration criteria, coffee P and the reference median, with evidence of correction/resolution
Cross-check the article's Methods, figures/results, original registration versions and correction records fact by fact, preserving incompatible pairs and the evidence for resolution.
27 Unverified Full text not readStored summary read N27 · Supplementary materialWhat is the actual acquisition scope for S1, S2 and the supplementary material?Required
S03 refers to S01's approximately 22.1 KB supplementary DOCX and S1/S2. QA06 corrected the link to the actual download URL and recorded the 403 failure at that time. External access has not been attempted in the current work; the content of S1/S2 and condition-specific analyses remain unverified.
Supplementary-material content is absent from the current input, and a past acquisition failure is recorded. The existence of a link alone does not support a claim that the full text was read or the analysis verified.
Corrected DOCX URL, original S1/S2 tables, content/version and actual access/acquisition records
Upon an authorized actual acquisition event, cross-check the DOCX version/original bytes and S1/S2 against the main-text contrasts, denominators and variances.
28 Partly verified Full text not readStored summary read N28 · Additional dose and juiceCan the findings be extended to the 500 mg comparison or juice alone?Supplementary; required for extension to dose/juice claims
The record reports P=0.226 for no verified additional increase with 500 mg over 80 mg, although absorption with the former condition was higher than with water. This does not prove equivalence or an optimal dose. The record that orange juice alone was not measured is retained.
The reported direction for the secondary dose and the limits on extrapolation are preserved. Paired intervals, an equivalence plan and a direct juice-alone comparison have not been verified.
Actual contrasts, variances/intervals for 500 mg versus 80 mg/water, and whether orange juice alone was measured separately
Examine prespecified dose contrasts/intervals, and address equivalence, optimal-dose or juice-alone questions through appropriate separate direct comparisons.
29 Unverified Full text not readStored summary read N29 · Other comparisons among the 6 conditionsHave secondary comparisons involving meals, coffee, timing and similar factors been kept separate from the main comparison?Required
The current evidence describes a crossover trial with 6 conditions and references secondary material in other_conditions.json. That separate file was not read this time. Conflicts in coffee P and the reference median are retained as QA04 records; those values are neither newly extracted nor merged into the main comparison.
Detailed contrasts/numbers for secondary conditions are absent from the current stored summary, so their actual direction and counterpart values for conflicts cannot be established.
Actual compositions, times and endpoint contrasts for the same trial's 6 conditions, and original records of conflicts in coffee P/reference medians
Check the table of 6 conditions, prespecified contrasts and original other_conditions records to attribute each result individually to the corresponding composition/time.
30 Partly verified Full text not readStored summary read N30 · Related dietary studiesWhat roles do the long-term balance, dietary and nonsimultaneous-administration studies in S05–S08 play?Required
S05–S08 concern apparent absorption with low iron stores, ongoing absorption/status, total-diet nonheme iron, and iron status/tea/AA in young Indian women. The original counterview records that null long-term balance findings, nonsimultaneous administration and whole-diet changes differ from this main comparison. The current bibliographic entries do not contain actual numerical results for each study.
The related questions and the historical boundaries on treating them as refutation have been read. Detailed exposure, denominators and results for each trial cannot be directly cross-checked from the current input alone.
Each study's actual population, diet/simultaneous exposure, absorption/balance endpoint, timing and original results/denominators
Cross-check each article's methods/original results separately to verify differences in simultaneous exposure, dietary changes, balance and isotope endpoints.
31 Partly verified Full text not readStored summary read N31 · Other populations and iron formulationsCan S09–S12 and S21 be combined as effects for the same main comparison?Required
S09 concerns overweight/obese women; S10 concerns ferrous fumarate, AA and Na2EDTA; S11's title concerns fortified foods, millet porridge and phytase/AA. S12 is a hematological comparison of daily/alternate-day iron, not single-ingredient AA addition. S21 provides a lead concerning inflammation, hepcidin and absorption in overweight women. No numerical results beyond the bibliographic verification level are added.
The roles of different questions in the titles and retained locations have been distinguished. Detailed original results/denominators and actual family identities are not provided in the current summary.
Actual ingredients/populations/measures and results in studies of overweight/obesity or inflammation, food fortification/phytase/Na2EDTA, and iron dosing schedules
Verify the actual populations, exposure/concomitant treatments, endpoints and study families of related studies individually to assess their directness for this question.
32 Unverified Full text not readStored summary read N32 · Registration and review leadsHas discovery of registrations/reviews in S18–S20 been treated as verification of results?Required
S18 is the indexed Study Plan for a registration concerning insect-derived dietary iron and chitin/AA. S19 is an indexed title of a fruit/juice review, with its full text recorded as not acquired. S20 is a title lead for FeHydroA; its exact registration URL remains unresolved. These are not counted as independent results for the current main comparison.
Plan/discovery identities are present, but no material is available to verify direct results, the review's included trials or the exact original S20 record.
Actual result status in the INSECTE registration, the included-trial table in the fruit/juice review, and the exact FeHydroA registration URL and original results
Cross-check posted registration results, review tables of included trials and exact records to distinguish unique trials/reports from information that remains a plan.
33 Partly verified Full text not readStored summary read N33 · Funding and product supplyWhat is the verification scope for ETH funding, product supply and conflicts of interest?Required
The retained record describes funding from the ETH Zurich Laboratory of Human Nutrition and a declaration of no competing financial interests. The Ferrum Hausmann/Vifor and Sigma Aldrich product names are not evidence of donated products or manufacturer funding. Product supply remains not reported.
The funding and declaration level are documented, but product supply and the full set of relationships cannot be established. The existing I2 is not reused as a new criterion assessment.
Actual records of ETH Zurich Laboratory of Human Nutrition funding, declarations of competing financial interests, product supply and institutional/author relationships
Cross-check funding/acknowledgments/COI and product-supply records to examine the level of disclosure and scope of funding/institutional independence.
34 Unverified Full text not readStored summary read N34 · Collection of trial harms dataCan adverse reactions and withdrawal frequencies under the same conditions be verified?Supplementary; required for extension to comparative harms/safety
Condition-specific adverse-reaction counts are recorded as not reported in the stored summary. Of 35 participants, 1 withdrew after the first visit because of difficulty maintaining the fast, but the condition is unverified. This is not recast as 0 AEs or an AA-related withdrawal.
Without condition-specific events, exposure denominators/periods and collection definitions, comparative harms, incidence and causality cannot be established.
Condition-specific AE definitions, collection methods, numbers of exposed people/people with events, event counts and periods, and the condition/causal attribution of the fasting-related withdrawal
Cross-check the AE collection plan, condition-specific event/exposure/withdrawal tables and follow-up records to verify event frequency and the scope of signal interpretation.
35 Met Full text not readStored summary read N35 · Official safety backgroundWhich safety questions do the NIH, NIDDK and NCI materials address?Supplementary; required for extension to individual/vulnerable-group safety
The retained general safety background includes a total-intake upper limit of 2,000 mg/day for adults aged 19 years and older, caution concerning iron overload and G6PD in the high-dose intravenous context. S13–S15 are official explanatory sources; they are not condition-specific event counts for oral 80 mg or individual intake recommendations.
The interpretive routes and age/exposure boundaries for each background source have been distinguished. This does not mean that external original texts or individual safety have been verified in the current work.
Scope of the UL of 2,000 mg/day for adults aged 19 years and older, caution concerning iron overload, the high-dose intravenous/G6PD context and the actual route/dose
Compare the populations/routes/doses in official safety materials with the trial, examining direct harms comparisons separately from general cautions.
36 Not applicable Full text not readStored summary read N36 · Extension of applicabilityCan the same effect be applied to other populations, durations and health endpoints?Supplementary; required for extended claims
Do not generalize directly to men, older people, people with normal iron stores, anemia, pregnancy/lactation, children, renal disease, iron overload or inflammatory disease. The direction of acute FIA is not a result for long-term maintenance, anemia treatment, fatigue/vitality or overall safety.
Confirmation of extended effects does not apply to this table's narrow question. No judgment has been made that evidence for each extension is absent or that the effect is null.
Direct data for men, older people, normal iron stores, anemia, pregnancy/lactation, children, renal disease/inflammation/iron overload and long-term/health endpoints
Examine direct comparisons and prespecified subgroups/interactions separately by population, exposure, duration and endpoint, designing necessary extension questions separately.
37 Met Full text not readStored summary read N37 · Preservation of the existing assessmentHave the original C/50, Caution and axes been kept from being reused as new criterion statuses?Required
Preserve the original C/50, Caution, the B·S·R1·I2·EX·CX·B2 axes and document quality as historical values. The existing scoring explanation involving n<200/completer analysis is not a minimum-participant criterion for the new table. No new calculation, grade or fulfillment rate was created.
The roles of existing values and new record statuses have been separated. Met in the table does not signify the original efficacy grade, confirmation of safety or a probability.
Separation of historical values for the original grade, score, safety, axes, document quality and assessment calculations from the new row statuses
Compare hashes/values between the original input and the produced version to check preservation of the assessment, axes and calculations, and audit the meaning of criterion statuses separately.
38 Met Full text not readStored summary read N38 · Reference dates and version recordsHave this table's input, criterion freeze, application and verification scope been recorded?Required
The evidence cutoff is 2026-09-16; records of 59 general web searches and 1 failed PubMed-specific search at that time are preserved. The 2026-10-05 review described here read the designated stored summary and family definitions, recording actual copies/hashes and individual criterion freezes/applications. External searches, full-text reading, API access, clinical calculations/reassessment and deployment are not performed.
The actual retained input/version, times and current work scope have been recorded. This is not official preregistration, independent clinical certification or an up-to-date verification of the entire literature.
The 2026-09-16 evidence cutoff and search scope at that time; the actual 2026-10-05 review, original bytes/SHA, and records of criteria frozen before application
Audit original bytes, pointers, versions/event times and row-level model records, updating new-material/criterion-revision events separately.
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38 itemsWhat the statuses mean

Assessment scope

Stored-material review date
2026-10-05
Original evidence cut-off
2026-09-16
Scope actually checked
Stored Korean and English manuscripts and case-specific criteria and application records. Full papers, supplements, registrations, plans and original data were not read.
What the dates mean
This is the date the stored materials were checked, not the date of an up-to-date clinical literature search.
Population
Nonpregnant, nonlactating women aged 18–45 years; ferritin ≤30 μg/L, Hb >12 g/dL, CRP <5 mg/L; BMI 18.5–26.5 kg/m², body weight <70 kg; no major chronic disease.
Ingredient, formulation and route
Addition of 80 mg of single-ingredient, food-grade L-ascorbic acid to the same fasted oral iron exposure
Dose
Ascorbic acid 80 mg + elemental iron 100 mg in a ferrous fumarate capsule + the reported isotope label 3 mg; author-reported ascorbic acid:iron molar ratio 0.24:1.
Comparator
The same participant takes the same labeled ferrous fumarate capsule with 200 mL of water at 07:00–09:00 in the morning after an overnight fast, without added ascorbic acid.
Measured outcome
Stable-isotope-derived fractional iron absorption (%); a model assuming 80% erythrocyte incorporation, distinct from hemoglobin or ferritin recovery.
Duration
Exposure 1 time per condition; crossover dosing days 1,3,5,22,24,26; according to the Methods section, isotope incorporation measured 17–21 days after each dose, with blood sampling on days 22/43.
Questions outside this scope
Anemia/Hb recovery, fatigue/vitality, long-term use/optimal dose, juice alone, salts/combination products, other iron formulations, meals, intravenous administration, other populations and individual safety are separate questions.

Evidence and sources

The links below lead to the sources. A link alone does not mean the original source was read or its latest publication status verified.

S01 · von Siebenthal HK et al. Effect of dietary factors and time of day on iron absorption from oral iron supplements in iron deficient women. Am J Hematol. 2023;98(9):1356–1363.

Source

Material type
Historical record of the original article's full HTML text
Materials actually read
Summary read: this source's identity/related records in the current retained stored summary were read. External material types were not read.
Findings recorded in the stored summary
Record at the time of retention: a randomized, open-label crossover trial with 6 conditions, each involving a single exposure. There were 35 enrolled and 34 completed/analyzed participants; 204 denotes repeated observations. With the added 80 mg, median FIA was 26.7% (IQR 19.1–32.6%); without the addition, it was 20.6% (IQR 12.3–25.5%), with P<0.001 preserved. The 6.1%p, 1.296 and approximately 29.6% are historical descriptive comparisons of marginal medians, not paired/adjusted effects or a CI.
Record level
Transformation of the retained 2026-09-16 KO/structured summary, bibliography and historical locations. This is not new verification of external content, numerical calculation or clinical reassessment.
Study overlap and independent replication
False
Public availability, access and reading status by material
MaterialPublic availabilityAccess statusActually readNotes
Full-text article HTML
Open material ↗
Unverified (no external lookup this time)Access not attemptedNot readThe current assessment's record of past full-HTML verification is not retrospectively treated as actual reading in the current work.
Full-text article PDF
Material URL unverified
Unverified (no external lookup this time)Access not attemptedNot readCurrent PDF acquisition/reading history is separately unverified; it is not retrospectively treated as actual reading in the current work.

S02 · PubMed bibliographic record for von Siebenthal et al. 2023

Source

Material type
Historical record of PubMed bibliographic information and abstract
Materials actually read
Summary read: this source's identity/related records in the current retained stored summary were read. External material types were not read.
Findings recorded in the stored summary
Record at the time of retention: bibliographic/abstract and indexed-notice locations for the same DOI 10.1002/ajh.26987 and PMID 37357807. This is the same article as S01 and is not counted as an independent replication.
Record level
Transformation of the retained 2026-09-16 KO/structured summary, bibliography and historical locations. This is not new verification of external content, numerical calculation or clinical reassessment.
Study overlap and independent replication
False
Public availability, access and reading status by material
MaterialPublic availabilityAccess statusActually readNotes
PubMed bibliographic information and abstract
Open material ↗
Unverified (no external lookup this time)Access not attemptedNot readHistorical locations of the bibliographic header, abstract and indexed notice are not retrospectively treated as actual reading in the current work.

S03 · S01 supporting information: ajh26987-sup-0001-Supinfo.docx

Source

Material type
Historical access failure for S01's supplementary DOCX
Materials actually read
Summary read: this source's identity/related records in the current retained stored summary were read. External material types were not read.
Findings recorded in the stored summary
Record at the time of retention: S01's supplementary DOCX (nominally approximately 22.1 KB) and references to S1/S2. The actual download URL in QA06 and the 403 failure at that time are preserved. Appendix content is currently unverified; the past failure is not retrospectively treated as inaccessibility this time.
Record level
Transformation of the retained 2026-09-16 KO/structured summary, bibliography and historical locations. This is not new verification of external content, numerical calculation or clinical reassessment.
Study overlap and independent replication
False
Public availability, access and reading status by material
MaterialPublic availabilityAccess statusActually readNotes
Article supplementary DOCX and S1/S2
Open material ↗
Unverified (no external lookup this time)Access not attemptedNot readCorrected actual download URL; the historical 403 record is not retrospectively treated as actual reading in the current work.

S04 · NCT04074707: Defining a Dosing Regimen With Maximal Absorption for Oral Iron Supplementation During Pregnancy

Source

Material type
Historical record of official registration index metadata
Materials actually read
Summary read: this source's identity/related records in the current retained stored summary were read. External material types were not read.
Findings recorded in the stored summary
Record at the time of retention: the officially indexed title for NCT04074707 concerns oral iron absorption during pregnancy. The retained record states that this does not match the current population; the complete registration/history could not be accessed in the past. It is not confirmed as the exact official registration for S01.
Record level
Transformation of the retained 2026-09-16 KO/structured summary, bibliography and historical locations. This is not new verification of external content, numerical calculation or clinical reassessment.
Study overlap and independent replication
False
Public availability, access and reading status by material
MaterialPublic availabilityAccess statusActually readNotes
Current official registration record
Open material ↗
Unverified (no external lookup this time)Access not attemptedNot readPast indexed verification of the official title/first-posting metadata is not retrospectively treated as actual reading in the current work.
Official registration version history
Material URL unverified
Unverified (no external lookup this time)Access not attemptedNot readPast failure to access the complete record/history; the direct history URL is unverified. This is not retrospectively treated as actual reading in the current work.

S05 · Hunt JR, Gallagher SK, Johnson LK. Effect of ascorbic acid on apparent iron absorption by women with low iron stores. AJCN. 1994;59:1381–1385.

Source

Material type
Historical location record for an article abstract
Materials actually read
Summary read: this source's identity/related records in the current retained stored summary were read. External material types were not read.
Findings recorded in the stored summary
Record at the time of retention: the title concerns apparent iron absorption in women with low iron stores, and the abstract's Methods/Results/Conclusions locations are recorded. This is linked to boundaries for other comparisons, such as long-term iron balance, in the current counterview manuscript. However, the bibliography lacks individual numerical results, so no identical FIA effect or null-result numbers are added.
Record level
Transformation of the retained 2026-09-16 KO/structured summary, bibliography and historical locations. This is not new verification of external content, numerical calculation or clinical reassessment.
Study overlap and independent replication
False
Public availability, access and reading status by material
MaterialPublic availabilityAccess statusActually readNotes
PubMed article bibliographic information and abstract
Open material ↗
Unverified (no external lookup this time)Access not attemptedNot readThe abstract's Methods/Results/Conclusions are not retrospectively treated as actual reading in the current work.

S06 · Hunt JR et al. Ascorbic acid: effect on ongoing iron absorption and status in iron-depleted young women. AJCN. 1990;51:649–655.

Source

Material type
Historical location records for an article abstract and a section of author-uploaded main text
Materials actually read
Summary read: this source's identity/related records in the current retained stored summary were read. External material types were not read.
Findings recorded in the stored summary
Record at the time of retention: the title concerns ongoing absorption and status in young iron-depleted women. The abstract and the Absorption of 59Fe section on p.652 of the author-uploaded main text are recorded as locations. Because the direct URL of the author's copy and individual numerical values are not currently provided, the PubMed URL is not attached as the full-text URL of the author's copy.
Record level
Transformation of the retained 2026-09-16 KO/structured summary, bibliography and historical locations. This is not new verification of external content, numerical calculation or clinical reassessment.
Study overlap and independent replication
False
Public availability, access and reading status by material
MaterialPublic availabilityAccess statusActually readNotes
PubMed article bibliographic information and abstract
Open material ↗
Unverified (no external lookup this time)Access not attemptedNot readThe historical location of the abstract is not retrospectively treated as actual reading in the current work.
Relevant section of the author-uploaded main text
Material URL unverified
Unverified (no external lookup this time)Access not attemptedNot readThe direct copy URL is unverified; only the p.652 location is preserved. This is not retrospectively treated as actual reading in the current work.

S07 · Cook JD, Reddy MB. Effect of ascorbic acid intake on nonheme-iron absorption from a complete diet. AJCN. 2001;73:93–98.

Source

Material type
Historical location record for an article abstract
Materials actually read
Summary read: this source's identity/related records in the current retained stored summary were read. External material types were not read.
Findings recorded in the stored summary
Record at the time of retention: the title concerns vitamin C intake and nonheme iron absorption from a complete diet, and the abstract location is recorded. Changes to the whole diet differ from the main comparison adding 80 mg simultaneously to the same capsule under fasted conditions. Results not provided in the current bibliography are not reconstructed.
Record level
Transformation of the retained 2026-09-16 KO/structured summary, bibliography and historical locations. This is not new verification of external content, numerical calculation or clinical reassessment.
Study overlap and independent replication
False
Public availability, access and reading status by material
MaterialPublic availabilityAccess statusActually readNotes
PubMed article bibliographic information and abstract
Open material ↗
Unverified (no external lookup this time)Access not attemptedNot readThe historical location of the abstract is not retrospectively treated as actual reading in the current work.

S08 · Thankachan P et al. Iron absorption in young Indian women: the interaction of iron status with the influence of tea and ascorbic acid. AJCN. 2008;87:881–886.

Source

Material type
Historical location records for an article abstract and indexed Methods/Table 1
Materials actually read
Summary read: this source's identity/related records in the current retained stored summary were read. External material types were not read.
Findings recorded in the stored summary
Record at the time of retention: the title concerns iron status and tea/ascorbic acid in young Indian women, with abstract and indexed Methods/Table 1 locations. Direct opening of the publisher's full text failed in the past. Because actual individual population/administration/numerical details are absent from the current bibliography, this is not counted as a replication of the same main comparison.
Record level
Transformation of the retained 2026-09-16 KO/structured summary, bibliography and historical locations. This is not new verification of external content, numerical calculation or clinical reassessment.
Study overlap and independent replication
False
Public availability, access and reading status by material
MaterialPublic availabilityAccess statusActually readNotes
PubMed bibliographic information, abstract/indexed methods
Open material ↗
Unverified (no external lookup this time)Access not attemptedNot readHistorical locations of the abstract and indexed Methods/Table 1 are not retrospectively treated as actual reading in the current work.
Publisher's full-text article
Material URL unverified
Unverified (no external lookup this time)Access not attemptedNot readThe direct publisher URL is currently unverified; the record of past failure to open the full text is not retrospectively treated as actual reading in the current work.

S09 · Cepeda-Lopez AC et al. In overweight and obese women, dietary iron absorption is reduced and the enhancement of iron absorption by ascorbic acid is one-half that in normal-weight women. AJCN. 2015;102:1389–1397.

Material type
Historical location record for an institutional-repository abstract
Materials actually read
Summary read: this source's identity/related records in the current retained stored summary were read. External material types were not read.
Findings recorded in the stored summary
Record at the time of retention: the title describes lower dietary iron absorption and a difference in AA enhancement in overweight/obese women. The historical location is an abstract in the authors' institutional repository; the record states that opening PubMed did not yield parsed body text. That abstract/numerical information has not been reread in the current work, and the population is not directly equated with this table's selection criteria for women.
Record level
Transformation of the retained 2026-09-16 KO/structured summary, bibliography and historical locations. This is not new verification of external content, numerical calculation or clinical reassessment.
Study overlap and independent replication
False
Public availability, access and reading status by material
MaterialPublic availabilityAccess statusActually readNotes
Article abstract in an institutional repository
Material URL unverified
Unverified (no external lookup this time)Access not attemptedNot readThe actual institutional-abstract URL is unverified and distinguished from PubMed. This is not retrospectively treated as actual reading in the current work.
PubMed article bibliographic information
Open material ↗
Unverified (no external lookup this time)Access not attemptedNot readBibliographic URL; no parsed body text was obtained during past opening. This is not retrospectively treated as actual reading in the current work.

S10 · Fidler MC et al. Iron absorption from ferrous fumarate in adult women is influenced by ascorbic acid but not by Na2EDTA. Br J Nutr. 2003.

Source

Material type
Historical location record for an article abstract
Materials actually read
Summary read: this source's identity/related records in the current retained stored summary were read. External material types were not read.
Findings recorded in the stored summary
Record at the time of retention: the bibliographic title concerns ferrous fumarate absorption and AA/Na2EDTA in adult women. Only the abstract location is currently retained, so no conclusion is drawn that the dose, meal, denominator or effect size is exactly the same as in this main comparison.
Record level
Transformation of the retained 2026-09-16 KO/structured summary, bibliography and historical locations. This is not new verification of external content, numerical calculation or clinical reassessment.
Study overlap and independent replication
False
Public availability, access and reading status by material
MaterialPublic availabilityAccess statusActually readNotes
PubMed article bibliographic information and abstract
Open material ↗
Unverified (no external lookup this time)Access not attemptedNot readThe historical location of the abstract is not retrospectively treated as actual reading in the current work.

S11 · Cercamondi CI et al. Iron bioavailability from a lipid-based complementary food fortificant mixed with millet porridge can be optimized by adding phytase and ascorbic acid but not by using a mixture of ferrous sulfate and sodium iron EDTA. J Nutr. 2013;143:1233–1239.

Source

Material type
Historical record of an article title and methods citation
Materials actually read
Summary read: this source's identity/related records in the current retained stored summary were read. External material types were not read.
Findings recorded in the stored summary
Record at the time of retention: the title concerns lipid-based fortified foods, millet porridge and phytase/AA, and the record identifies it as a methods source cited in S01. Past opening did not yield parsed body text. This is not promoted to an independent effect result for the main comparison or to full-text verification.
Record level
Transformation of the retained 2026-09-16 KO/structured summary, bibliography and historical locations. This is not new verification of external content, numerical calculation or clinical reassessment.
Study overlap and independent replication
False
Public availability, access and reading status by material
MaterialPublic availabilityAccess statusActually readNotes
PubMed article bibliographic information/indexed title
Open material ↗
Unverified (no external lookup this time)Access not attemptedNot readTitle and methods citation; no parsed body text was obtained in the past. This is not retrospectively treated as actual reading in the current work.
Full-text article
Material URL unverified
Unverified (no external lookup this time)Access not attemptedNot readThe direct full-text URL and acquisition are currently unverified. This is not retrospectively treated as actual reading in the current work.

S12 · John et al. Daily oral iron supplementation produced greater improvements in hematological parameters than alternate day doses – A pilot double-blind randomized control trial in iron-deficient young women. Clin Nutr. 2026;56:106520.

Source

Material type
Historical location record for an indexed abstract
Materials actually read
Summary read: this source's identity/related records in the current retained stored summary were read. External material types were not read.
Findings recorded in the stored summary
Record at the time of retention: a comparison of daily/alternate-day oral iron in young iron-deficient women, published online on 2025-11-25 and in the 2026 issue for month 1. The question concerns hematological outcomes/iron dosing schedules, not an FIA comparison adding only AA to the same iron. Publication timing is preserved only as the bibliographic record from that time.
Record level
Transformation of the retained 2026-09-16 KO/structured summary, bibliography and historical locations. This is not new verification of external content, numerical calculation or clinical reassessment.
Study overlap and independent replication
False
Public availability, access and reading status by material
MaterialPublic availabilityAccess statusActually readNotes
PubMed article bibliographic information and indexed abstract
Open material ↗
Unverified (no external lookup this time)Access not attemptedNot readOnline/issue publication metadata and the indexed abstract are not retrospectively treated as actual reading in the current work.

S13 · NIH Office of Dietary Supplements: Vitamin C, Health Professional Fact Sheet

Source

Material type
Historical record of official general-safety web material
Materials actually read
Summary read: this source's identity/related records in the current retained stored summary were read. External material types were not read.
Findings recorded in the stored summary
General safety background recorded at the time of retention: linked to excessive-intake risks and Table 3 in the general safety background. The retained KO UL of 2,000 mg/day for adults aged 19 years and older is neither an individual intake recommendation nor safety certification for this 80 mg condition.
Record level
Transformation of the retained 2026-09-16 KO/structured summary, bibliography and historical locations. This is not new verification of external content, numerical calculation or clinical reassessment.
Study overlap and independent replication
False
Public availability, access and reading status by material
MaterialPublic availabilityAccess statusActually readNotes
Safety section/table in official NIH ODS web material
Open material ↗
Unverified (no external lookup this time)Access not attemptedNot readHealth Risks from Excessive Vitamin C; Table 3. This is not retrospectively treated as actual reading in the current work.

S14 · NIDDK: Eating, Diet, & Nutrition for Hemochromatosis

Source

Material type
Historical record of official general-safety web material
Materials actually read
Summary read: this source's identity/related records in the current retained stored summary were read. External material types were not read.
Findings recorded in the stored summary
General safety background recorded at the time of retention: the foods-to-avoid section of NIDDK's hemochromatosis material. General caution about iron overload is not converted into direct AE counts in young nonanemic women or into individual safety.
Record level
Transformation of the retained 2026-09-16 KO/structured summary, bibliography and historical locations. This is not new verification of external content, numerical calculation or clinical reassessment.
Study overlap and independent replication
False
Public availability, access and reading status by material
MaterialPublic availabilityAccess statusActually readNotes
Diet/cautions section in official NIDDK web material
Open material ↗
Unverified (no external lookup this time)Access not attemptedNot readThe relevant hemochromatosis diet/nutrition section is not retrospectively treated as actual reading in the current work.

S15 · National Cancer Institute: Intravenous Vitamin C (PDQ), Health Professional Version

Source

Material type
Historical record of official general-safety web material
Materials actually read
Summary read: this source's identity/related records in the current retained stored summary were read. External material types were not read.
Findings recorded in the stored summary
General safety background recorded at the time of retention: the Adverse Effects location in NCI's intravenous vitamin C PDQ. The retained KO distinguishes the high-dose intravenous/G6PD context from direct application to the 80 mg oral trial.
Record level
Transformation of the retained 2026-09-16 KO/structured summary, bibliography and historical locations. This is not new verification of external content, numerical calculation or clinical reassessment.
Study overlap and independent replication
False
Public availability, access and reading status by material
MaterialPublic availabilityAccess statusActually readNotes
Intravenous vitamin C safety section in official NCI web material
Open material ↗
Unverified (no external lookup this time)Access not attemptedNot readThe different route/dose context of Adverse Effects is not retrospectively treated as actual reading in the current work.

S16 · IAEA. Assessment of Iron Bioavailability in Humans Using Stable Iron Isotope Techniques. Human Health Series 21. Vienna, 2012. STI/PUB/1544.

Source

Material type
Historical record of relevant sections/figures in the IAEA methods PDF
Materials actually read
Summary read: this source's identity/related records in the current retained stored summary were read. External material types were not read.
Findings recorded in the stored summary
Record at the time of retention: IAEA 2012 Human Health Series 21, §7.4 pp.37–38/PDF48–49 equation 18, and §8.1 pp.39–40/figure p.40. This is methodological background for isotope dilution/incorporation models, not a new clinical replication or verification of individual incorporation fractions in this population.
Record level
Transformation of the retained 2026-09-16 KO/structured summary, bibliography and historical locations. This is not new verification of external content, numerical calculation or clinical reassessment.
Study overlap and independent replication
False
Public availability, access and reading status by material
MaterialPublic availabilityAccess statusActually readNotes
Relevant sections and figures in the IAEA methods PDF
Open material ↗
Unverified (no external lookup this time)Access not attemptedNot readHistorical locations in §7.4/8.1, equation 18 and the corresponding pages are not retrospectively treated as actual reading in the current work.

S17 · NCT05414474: Effects of Enhancers and Inhibitors on Absorption From Iron Supplements (IDEA)

Material type
Historical provisional link to a registration-data mirror
Materials actually read
Summary read: this source's identity/related records in the current retained stored summary were read. External material types were not read.
Findings recorded in the stored summary
Record at the time of retention: the Veeva registration-data mirror for NCT05414474 was linked by inference because of the same 6 conditions, investigators and enrollment. Official version history is unverified. Because the actual mirror URL is unavailable, the official ClinicalTrials.gov URL is not attached as though it were the mirror's original text.
Record level
Transformation of the retained 2026-09-16 KO/structured summary, bibliography and historical locations. This is not new verification of external content, numerical calculation or clinical reassessment.
Study overlap and independent replication
False
Public availability, access and reading status by material
MaterialPublic availabilityAccess statusActually readNotes
Veeva registration-data mirror
Material URL unverified
Unverified (no external lookup this time)Access not attemptedNot readThe actual mirror URL is unverified and distinguished from the official URL. This is not retrospectively treated as actual reading in the current work.
Current official registration record
Open material ↗
Unverified (no external lookup this time)Access not attemptedNot readBibliographic reference to the official canonical URL; this does not verify current or past official content. It is not retrospectively treated as actual reading in the current work.
Official registration version history
Material URL unverified
Unverified (no external lookup this time)Access not attemptedNot readPast access failure and an unverified direct history URL are not retrospectively treated as actual reading in the current work.

S18 · NCT06822062: Effect of Chitin and Ascorbic Acid on Dietary Insect Iron Absorption (INSECTE)

Source

Material type
Historical record of an officially indexed registration plan
Materials actually read
Summary read: this source's identity/related records in the current retained stored summary were read. External material types were not read.
Findings recorded in the stored summary
Record at the time of retention: the indexed Study Plan location for NCT06822062 INSECTE (meals A–G, primary outcome). This is a registered plan, not counted as a completed result matching the current main comparison or an independent replication.
Record level
Transformation of the retained 2026-09-16 KO/structured summary, bibliography and historical locations. This is not new verification of external content, numerical calculation or clinical reassessment.
Study overlap and independent replication
False
Public availability, access and reading status by material
MaterialPublic availabilityAccess statusActually readNotes
Current official registration record/plan
Open material ↗
Unverified (no external lookup this time)Access not attemptedNot readThe historical location of the indexed Study Plan is not retrospectively treated as actual reading in the current work.

S19 · Does consuming ascorbate-rich fruits and fruit juices with meals improve iron bioavailability? 2026 review discovery

Source

Material type
Historical discovery of an indexed review title
Materials actually read
Summary read: this source's identity/related records in the current retained stored summary were read. External material types were not read.
Findings recorded in the stored summary
Record at the time of retention: an indexed title discovered for a 2026 fruit/juice review, with the full text recorded as not acquired. Because the included-trial table and individual effects are currently unavailable, this is not promoted to an independent absorption-trial result or to reading of the complete review.
Record level
Transformation of the retained 2026-09-16 KO/structured summary, bibliography and historical locations. This is not new verification of external content, numerical calculation or clinical reassessment.
Study overlap and independent replication
False
Public availability, access and reading status by material
MaterialPublic availabilityAccess statusActually readNotes
Indexed review title/bibliographic information
Open material ↗
Unverified (no external lookup this time)Access not attemptedNot readThe historical location of the indexed discovery is not retrospectively treated as actual reading in the current work.
Full review text and included-trial table
Material URL unverified
Unverified (no external lookup this time)Access not attemptedNot readFull text not acquired; the direct full-text file URL is unverified. This is not retrospectively treated as actual reading in the current work.

S20 · Iron Absorption from a Dietary Supplement, FeHydroA registry lead

Material type
Registration lead with unresolved exact URL
Materials actually read
Summary read: this source's identity/related records in the current retained stored summary were read. External material types were not read.
Findings recorded in the stored summary
Record at the time of retention: an indexed title lead for FeHydroA, with the exact record URL unresolved. A portal homepage is neither a link to that actual registration record nor evidence of results.
Record level
Transformation of the retained 2026-09-16 KO/structured summary, bibliography and historical locations. This is not new verification of external content, numerical calculation or clinical reassessment.
Study overlap and independent replication
False
Public availability, access and reading status by material
MaterialPublic availabilityAccess statusActually readNotes
Exact FeHydroA registration record
Material URL unverified
Unverified (no external lookup this time)Access not attemptedNot readThe exact record URL is unresolved; the portal homepage is a separate bibliographic reference. This is not retrospectively treated as actual reading in the current work.

S21 · Effects of reducing chronic inflammation in overweight women on serum hepcidin and iron absorption with and without supplemental ascorbic acid. Br J Nutr. 2020 online.

Source

Material type
Historical lead from an indexed study description
Materials actually read
Summary read: this source's identity/related records in the current retained stored summary were read. External material types were not read.
Findings recorded in the stored summary
Record at the time of retention: an indexed study description concerning reduced chronic inflammation, hepcidin and absorption with/without AA in overweight women. No full-text verification of actual endpoints, exposure or numbers is added, and it is not merged into the same direct main comparison in a population with low inflammation and a restricted BMI range.
Record level
Transformation of the retained 2026-09-16 KO/structured summary, bibliography and historical locations. This is not new verification of external content, numerical calculation or clinical reassessment.
Study overlap and independent replication
False
Public availability, access and reading status by material
MaterialPublic availabilityAccess statusActually readNotes
Publisher's indexed study description/bibliographic information
Open material ↗
Unverified (no external lookup this time)Access not attemptedNot readThe historical location of the retained indexed description is not retrospectively treated as actual reading in the current work.

P907 · Supplied completed verdict 907: vitamin C plus oral iron and additional hemoglobin recovery

Source

Material type
Historical reference to an existing assessment/sealed input
Materials actually read
Summary read: this source's identity/related records in the current retained stored summary were read. External material types were not read.
Findings recorded in the stored summary
Record at the time of retention: the existing 907 addresses additional Hb recovery with vitamin C+oral iron. QA01 is preserved: this was not treated as a duplicate of the FIA table solely because of the same ingredient/route. The separate 907 input and public page were not opened this time.
Record level
Transformation of the retained 2026-09-16 KO/structured summary, bibliography and historical locations. This is not new verification of external content, numerical calculation or clinical reassessment.
Study overlap and independent replication
False
Public availability, access and reading status by material
MaterialPublic availabilityAccess statusActually readNotes
Public page for an existing Chamgap assessment
Open material ↗
Unverified (no external lookup this time)Access not attemptedNot readThe historical reference to the public assessment URL is not retrospectively treated as actual reading in the current work.
Sealed copy of the existing assessment input
Material URL unverified
Unverified (no external lookup this time)Access not attemptedNot readThe separate 907.json is absent from the current input and was not read this time. It is not retrospectively treated as actual reading in the current work.

Report counts versus independent study counts

These are report links in the stored manuscript. Main text, index and supplementary material for the same article (S01, S02, S03) / A probable registration-mirror link for F01, not confirmed through official version history (S17) / Related articles, methodological/safety explanations, registrations, reviews and an existing assessment. Without a current individual family table, these are not automatically added to the number of directly eligible unique families (S04, S05, S06, S07, S08, S09, S10, S11, S12, S13, S14, S15, S16, S18, S19, S20, S21, P907). The overall number of unique trials and total participant count are unverified. Verification of the stored summary is distinguished from not having read the original materials this time; report/family labels are not summed into total trial or participant counts.

Review criteria

Version NGM-v3115-LOW-STORES-NONANEMIC-FIA-1.0 · Criteria record date 2026-10-05. These are Chamgap's own application conditions, informed by the referenced methods. They do not constitute official assessment-tool certification or a new efficacy score.

N01 · Which iron absorption comparison does this table address?
Required materials and conditions
Identity of the question: nonanemic women with low iron stores, oral single-ingredient L-ascorbic acid, an identical-iron comparator and isotope-measured fractional iron absorption
Conditions for verification
Preserve the exact /ko/effect and link the scope to the single comparison adding 80 mg to the same fasted iron exposure.
Requirement and applicability
Required
Application exceptions
The subclaims array is empty. No additional main table is created for anemia treatment, Hb recovery, fatigue or long-term health effects.
Why this condition is needed
Needed to avoid merging this absorption question with anemia-treatment assessment 907, which involves the same ingredient and route, or with the energy classification.
Referenced methods
C01: Principles for clarifying the question in M03 §3.1, §3.2.1–3.2.4; detailed separation rules are internally designed / C04: M03 §3.2.1; detailed population criteria are internally designed / C05: M03 §3.2.2–3.2.3; reverse-direction labeling and adaptation for testing are internally designed / C06: M03 §3.2.4, M15 §15.3.1–15.3.3; outcome adaptation for each question is internally designed / E09: M03 §3.2.4; internally defined limits on extrapolation. The rationale for application to this case is to avoid merging this absorption question with anemia-treatment assessment 907, which involves the same ingredient and route, or with the energy classification. This does not constitute new reading of full methods texts, formal application of RoB 2/GRADE/causal tools or certification of minimum clinical criteria.
N02 · To which article is the main absorption result attributed?
Required materials and conditions
Link between the stored summary and the title, DOI, PMID and Methods/Results locations of the von Siebenthal 2023 article
Conditions for verification
Link the DOI 10.1002/ajh.26987, PMID 37357807 and main-result locations in S01 and S02 to the same article.
Requirement and applicability
Required
Application exceptions
Verification of bibliographic agreement does not replace rereading the full text or certification of original-data accuracy.
Why this condition is needed
Needed to avoid interpreting ‘iron deficient’ in the bibliographic title as anemia-treatment evidence extending beyond the current population with Hb >12 g/dL.
Referenced methods
C02: Distinction between studies and reports in M04 §4.6.1–4.6.2; cohort/outcome linkage is an internal application / C03: Principles for data collection/selection in M04 §4.5–4.6; separation of access from reading and the hyperlink contract are internally designed / C06: M03 §3.2.4, M15 §15.3.1–15.3.3; outcome adaptation for each question is internally designed. The rationale for application to this case is to avoid interpreting ‘iron deficient’ in the bibliographic title as anemia-treatment evidence extending beyond the current population with Hb >12 g/dL. This does not constitute new reading of full methods texts, formal application of RoB 2/GRADE/causal tools or certification of minimum clinical criteria.
N03 · Are the 22 bibliographic entries being kept distinct from independent absorption trials?
Required materials and conditions
The same-article relationship of S01/S02/S03, the provisional registration link in S17 and the roles of each related article, official explanatory source, registration and 907
Conditions for verification
Identify verified reports belonging to the same family and provisional/unverified links, distinguishing the bibliographic count from the number of direct trials.
Requirement and applicability
Required
Application exceptions
Because sources and trial_families are absent from the current stored summary, no new definitive count of unique families for other cohorts is made.
Why this condition is needed
Needed to prevent an article's main text, index and appendix, safety explanations and registration clues from being double-counted as separate direct replications.
Referenced methods
C02: Distinction between studies and reports in M04 §4.6.1–4.6.2; cohort/outcome linkage is an internal application / E07: M04 §4.6.1–4.6.2, M15 §15.3.1; internal application / H07: M04 §4.6.1–4.6.2; adaptation for harms material is internally designed. The rationale for application to this case is to prevent an article's main text, index and appendix, safety explanations and registration clues from being double-counted as separate direct replications. This does not constitute new reading of full methods texts, formal application of RoB 2/GRADE/causal tools or certification of minimum clinical criteria.
N04 · Have materials actually read now been distinguished from full texts read in the past?
Required materials and conditions
Sections, bibliography and dates actually read in the current source's stored summary; historical HTML/index/mirror/failure records; and current status by external material type
Conditions for verification
Separate reading of the current stored summary from external access not attempted/materials not acquired/not read, and attach only links appropriate to each material type.
Requirement and applicability
Required
Application exceptions
Preserve the past supplementary-material 403 and failed registration-history access as historical records, without labeling them as current inaccessibility.
Why this condition is needed
Needed to avoid treating past verification or the existence of an original-source URL as external full-text reading performed this time.
Referenced methods
C03: Principles for data collection/selection in M04 §4.5–4.6; separation of access from reading and the hyperlink contract are internally designed / C09: M04 §4.5, §4.6.3; limits on the current data transformation follow the user-defined scope and internal design. The rationale for application to this case is to avoid treating past verification or the existence of an original-source URL as external full-text reading performed this time. This does not constitute new reading of full methods texts, formal application of RoB 2/GRADE/causal tools or certification of minimum clinical criteria.
N05 · What were the actual population's iron stores, anemia status and selection criteria?
Required materials and conditions
Criteria for the women's age, pregnancy/lactation, ferritin, Hb, CRP, BMI, weight and disease status, together with baseline characteristics/selection flow
Conditions for verification
Link ferritin ≤30 μg/L, Hb >12 g/dL and the other criteria for the actual nonpregnant, nonlactating women aged 18–45 years to the limits of applicability.
Requirement and applicability
Required
Application exceptions
Iron-store criteria alone do not establish vitamin C deficiency, absence of iron overload or representativeness.
Why this condition is needed
Needed to avoid equating low iron stores with confirmed anemia or with all iron-deficient populations.
Referenced methods
C04: M03 §3.2.1; detailed population criteria are internally designed / E01: M08 §8.1–8.2.3; internal application. The rationale for application to this case is to avoid equating low iron stores with confirmed anemia or with all iron-deficient populations. This does not constitute new reading of full methods texts, formal application of RoB 2/GRADE/causal tools or certification of minimum clinical criteria.
N06 · Can this be interpreted as an effect of correcting vitamin C deficiency or of the habitual diet?
Required materials and conditions
Baseline vitamin C testing, habitual diet/total intake and whether deficiency was a selection criterion
Conditions for verification
Identify the actual reporting scope for baseline vitamin C status, habitual diet and total intake, without classifying this as a deficiency trial.
Requirement and applicability
Required
Application exceptions
Tests retained as not reported are not filled in as normal values or deficiency.
Why this condition is needed
Needed to avoid recasting the absorption comparison as an effect of correcting vitamin C deficiency or of changing total dietary intake.
Referenced methods
C04: M03 §3.2.1; detailed population criteria are internally designed / C05: M03 §3.2.2–3.2.3; reverse-direction labeling and adaptation for testing are internally designed / E02: M03 §3.2.3, M08 §8.2.2–8.2.3; internal application. The rationale for application to this case is to avoid recasting the absorption comparison as an effect of correcting vitamin C deficiency or of changing total dietary intake. This does not constitute new reading of full methods texts, formal application of RoB 2/GRADE/causal tools or certification of minimum clinical criteria.
N07 · Have selection boundaries relating to iron, renal status and G6PD been verified?
Required materials and conditions
Entry criteria for TSAT and renal function, procedures for iron-overload and G6PD screening, and participant-specific records
Conditions for verification
Retain unverified information for each entry/screening record and identify boundaries for safety interpretation appropriate to the route and dose.
Requirement and applicability
Required
Application exceptions
The safety context of G6PD and high-dose intravenous administration is not transferred to the 80 mg oral exposure as an equivalent risk estimate.
Why this condition is needed
Needed to avoid establishing specific screening or individual safety solely from a statement excluding major chronic diseases.
Referenced methods
C04: M03 §3.2.1; detailed population criteria are internally designed / H05: Design considerations in M19 §19.2.2–19.2.4; detailed confounding records are internally designed / H08: M19 §19.1.2–19.2.4; internal application. The rationale for application to this case is to avoid establishing specific screening or individual safety solely from a statement excluding major chronic diseases. This does not constitute new reading of full methods texts, formal application of RoB 2/GRADE/causal tools or certification of minimum clinical criteria.
N08 · What are the identities of the trial's vitamin C ingredient and product?
Required materials and conditions
Actual manufacturing origin, lot and purity of Sigma Aldrich food-grade, single-ingredient L-ascorbic acid, and its distinction from other formulations
Conditions for verification
Distinguish food-grade L-ascorbic acid as a single ingredient from verified/unverified product attributes.
Requirement and applicability
Required
Application exceptions
Do not fill unverified manufacturing origin, lot or purity with estimates, or infer product supply/funding from a brand name.
Why this condition is needed
Needed to avoid assuming an exposure equivalent to salts, juice or combination products solely from a trade name or the name vitamin C.
Referenced methods
C05: M03 §3.2.2–3.2.3; reverse-direction labeling and adaptation for testing are internally designed / E02: M03 §3.2.3, M08 §8.2.2–8.2.3; internal application. The rationale for application to this case is to avoid assuming an exposure equivalent to salts, juice or combination products solely from a trade name or the name vitamin C. This does not constitute new reading of full methods texts, formal application of RoB 2/GRADE/causal tools or certification of minimum clinical criteria.
N09 · By what route and in what prepared form were they administered together?
Required materials and conditions
Oral coadministration of L-ascorbic acid dissolved in water, distinguished from the iron capsule and meal/juice/intravenous conditions
Conditions for verification
Identify the addition of a single-ingredient oral aqueous solution together with exposure to the same iron capsule, excluding other routes/formulations.
Requirement and applicability
Required
Application exceptions
An intravenous-administration trial is not required as direct evidence for this narrow oral condition.
Why this condition is needed
Needed to avoid replacing the actual route and medium of the absorption comparison with efficacy or safety information from another route.
Referenced methods
C05: M03 §3.2.2–3.2.3; reverse-direction labeling and adaptation for testing are internally designed / E02: M03 §3.2.3, M08 §8.2.2–8.2.3; internal application / E08: M03 §3.2.1–3.2.4; details of dose, duration and effect modification are internally designed. The rationale for application to this case is to avoid replacing the actual route and medium of the absorption comparison with efficacy or safety information from another route. This does not constitute new reading of full methods texts, formal application of RoB 2/GRADE/causal tools or certification of minimum clinical criteria.
N10 · How are the 100 mg capsule and the amount of isotope label distinguished?
Required materials and conditions
The capsule's 100 mg of elemental iron, the reported 3 mg label, the authors' molar ratio of 0.24:1 and explicit information on actual total elemental iron
Conditions for verification
Preserve separately the nominal capsule amount, label amount, unverified total and author-reported molar ratio.
Requirement and applicability
Required
Application exceptions
Do not add the reported label amount to create a new total or recalculate the authors' molar ratio.
Why this condition is needed
Needed to avoid treating the capsule amount as total exposure or arbitrarily deriving absolute absorbed mg from fractional absorption.
Referenced methods
C05: M03 §3.2.2–3.2.3; reverse-direction labeling and adaptation for testing are internally designed / C06: M03 §3.2.4, M15 §15.3.1–15.3.3; outcome adaptation for each question is internally designed / E04: M08 §8.2.2, M15 §15.3.1; internal application. The rationale for application to this case is to avoid treating the capsule amount as total exposure or arbitrarily deriving absolute absorbed mg from fractional absorption. This does not constitute new reading of full methods texts, formal application of RoB 2/GRADE/causal tools or certification of minimum clinical criteria.
N11 · Apart from the added 80 mg, are the iron and water exposures identical in the main comparison?
Required materials and conditions
The same participant's exposure to the same labeled iron capsule and 200 mL of water, with or without added ascorbic acid, and actual records of common concomitant treatments
Conditions for verification
Link the selected main comparison to whether it adds only 80 mg of ascorbic acid under the same fasted iron-and-water conditions.
Requirement and applicability
Required
Application exceptions
Compare only the two selected conditions, without forcing all elements of the 6 different conditions into a common control.
Why this condition is needed
Needed to distinguish the contribution of added vitamin C from other differences in iron dose, medium or concomitant treatments.
Referenced methods
C05: M03 §3.2.2–3.2.3; reverse-direction labeling and adaptation for testing are internally designed / E02: M03 §3.2.3, M08 §8.2.2–8.2.3; internal application. The rationale for application to this case is to distinguish the contribution of added vitamin C from other differences in iron dose, medium or concomitant treatments. This does not constitute new reading of full methods texts, formal application of RoB 2/GRADE/causal tools or certification of minimum clinical criteria.
N12 · What were the meal and morning dosing conditions for the absorption comparison?
Required materials and conditions
Procedures for overnight fasting, morning dosing at 07:00–09:00 and simultaneous administration, with actual adherence records by condition
Conditions for verification
Identify fasting, administration time, simultaneous administration and unverified adherence separately.
Requirement and applicability
Required
Application exceptions
Do not arbitrarily attribute the 1 withdrawal due to difficulty adhering to fasting to a safety event or failure of a particular condition.
Why this condition is needed
Needed to avoid extending the result for high-dose iron in the fasted state to an identical effect size during routine use with meals.
Referenced methods
C05: M03 §3.2.2–3.2.3; reverse-direction labeling and adaptation for testing are internally designed / E02: M03 §3.2.3, M08 §8.2.2–8.2.3; internal application / E08: M03 §3.2.1–3.2.4; details of dose, duration and effect modification are internally designed. The rationale for application to this case is to avoid extending the result for high-dose iron in the fasted state to an identical effect size during routine use with meals. This does not constitute new reading of full methods texts, formal application of RoB 2/GRADE/causal tools or certification of minimum clinical criteria.
N13 · Have single-exposure absorption measurements been distinguished from the duration of long-term use?
Required materials and conditions
Dosing days 1·3·5·22·24·26 for the 6 conditions, blood sampling on days 22/43 in the Methods section, incorporation measurements 17–21 days after administration of each label and records of conflicting information
Conditions for verification
Separate exposure 1 time per condition from the incorporation-measurement window, linking both the Methods schedule and the unresolved schedule conflict.
Requirement and applicability
Required
Application exceptions
Preserve the Methods schedule with its source attribution, without treating it as a definitive resolution of the conflicting final blood-sampling dates.
Why this condition is needed
Needed to avoid turning the incorporation-observation period into a period of long-term vitamin C administration or sustained absorption effects.
Referenced methods
C05: M03 §3.2.2–3.2.3; reverse-direction labeling and adaptation for testing are internally designed / C06: M03 §3.2.4, M15 §15.3.1–15.3.3; outcome adaptation for each question is internally designed / E08: M03 §3.2.1–3.2.4; details of dose, duration and effect modification are internally designed / C08: M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses is internally designed. The rationale for application to this case is to avoid turning the incorporation-observation period into a period of long-term vitamin C administration or sustained absorption effects. This does not constitute new reading of full methods texts, formal application of RoB 2/GRADE/causal tools or certification of minimum clinical criteria.
N14 · What was the actual extent of crossover allocation and blinding?
Required materials and conditions
Computer-generated crossover sequence, allocation-concealment/laboratory-blinding/open-label procedures, and baseline/sequence data
Conditions for verification
Distinguish the actual open-label randomized crossover design and reported/unreported procedures in relation to the endpoint.
Requirement and applicability
Required
Application exceptions
An open-label design or unreported blinding does not automatically render the measurement invalid.
Why this condition is needed
Needed to avoid assuming that concealment, assessment blinding or allocation problems have been resolved solely because the study is described as randomized.
Referenced methods
E01: M08 §8.1–8.2.3; internal application / E03: M08 Table 8.2.a, M03 §3.2.4; internal application / C04: M03 §3.2.1; detailed population criteria are internally designed. The rationale for application to this case is to avoid assuming that concealment, assessment blinding or allocation problems have been resolved solely because the study is described as randomized. This does not constitute new reading of full methods texts, formal application of RoB 2/GRADE/causal tools or certification of minimum clinical criteria.
N15 · Can 35 participants, 34 participants and 204 observations be distinguished?
Required materials and conditions
35 enrolled participants, 34 analyzed participants who completed the 6 conditions, 204 observations, and linkage of the same participants across the two selected conditions
Conditions for verification
Link the original enrollment/completion/analysis/observation counts unchanged, identifying the comparison as paired within the same 34 participants.
Requirement and applicability
Required
Application exceptions
Do not turn 204 observations into 204 participants or calculate a new total participant count.
Why this condition is needed
Needed to avoid counting repeated observations as people or combining the same 34 participants as two independent groups.
Referenced methods
C07: M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; adaptations by design are internally designed / E04: M08 §8.2.2, M15 §15.3.1; internal application. The rationale for application to this case is to avoid counting repeated observations as people or combining the same 34 participants as two independent groups. This does not constitute new reading of full methods texts, formal application of RoB 2/GRADE/causal tools or certification of minimum clinical criteria.
N16 · Have the completer analysis, withdrawal and imputation records been distinguished?
Required materials and conditions
Reason/condition for the 1 withdrawal after the first visit, the per-protocol completer analysis, and separate handling of CRP imputation and missing FIA data
Conditions for verification
Preserve separately the distinction between the analysis of 34 completers and enrollment of 35 participants, the imputed variable and the unverified condition of withdrawal.
Requirement and applicability
Required
Application exceptions
Do not attribute the withdrawal to an adverse effect of iron or vitamin C while its condition remains unverified.
Why this condition is needed
Needed to avoid treating completer results as the effect in all randomized participants or mistaking CRP imputation for absorption-rate imputation.
Referenced methods
C07: M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; adaptations by design are internally designed / E04: M08 §8.2.2, M15 §15.3.1; internal application / H06: M19 §19.1.2–19.2.4, M04 §4.6.3; internal application. The rationale for application to this case is to avoid treating completer results as the effect in all randomized participants or mistaking CRP imputation for absorption-rate imputation. This does not constitute new reading of full methods texts, formal application of RoB 2/GRADE/causal tools or certification of minimum clinical criteria.
N17 · How were adherence and period, sequence and carryover effects handled?
Required materials and conditions
Records of supervised administration, period/sequence/carryover effects and interactions, and definitions of the actual crossover model and contrast
Conditions for verification
Separate the reporting level for supervised administration from unverified crossover handling, and link the scope of verification for paired/adjusted effects.
Requirement and applicability
Required
Application exceptions
Unverified interactions are not treated as established carryover bias or a null effect.
Why this condition is needed
Needed to avoid assuming that time/sequence effects and all confounding were eliminated solely because the comparison was repeated within the same individuals.
Referenced methods
E02: M03 §3.2.3, M08 §8.2.2–8.2.3; internal application / E04: M08 §8.2.2, M15 §15.3.1; internal application / C06: M03 §3.2.4, M15 §15.3.1–15.3.3; outcome adaptation for each question is internally designed. The rationale for application to this case is to avoid assuming that time/sequence effects and all confounding were eliminated solely because the comparison was repeated within the same individuals. This does not constitute new reading of full methods texts, formal application of RoB 2/GRADE/causal tools or certification of minimum clinical criteria.
N18 · Which test and unit define the fractional iron absorption result?
Required materials and conditions
Erythrocyte incorporation of 54Fe·57Fe·58Fe, the dilution method, label-specific measurement windows, the definition of FIA (%) and assay quality
Conditions for verification
Link the selected endpoint to stable-isotope-derived FIA (%) and distinguish it from other iron/hemoglobin outcomes.
Requirement and applicability
Required
Application exceptions
An objective test is not converted into direct proof of clinical events/patient-centered benefit.
Why this condition is needed
Needed to avoid confusing increased blood iron, Hb recovery or ferritin changes with actual stable-isotope absorption measurements.
Referenced methods
C06: M03 §3.2.4, M15 §15.3.1–15.3.3; outcome adaptation for each question is internally designed / E03: M08 Table 8.2.a, M03 §3.2.4; internal application / E09: M03 §3.2.4; internally defined limits on extrapolation. The rationale for application to this case is to avoid confusing increased blood iron, Hb recovery or ferritin changes with actual stable-isotope absorption measurements. This does not constitute new reading of full methods texts, formal application of RoB 2/GRADE/causal tools or certification of minimum clinical criteria.
N19 · What does the assumption of 80% erythrocyte incorporation mean?
Required materials and conditions
The 80% incorporation assumption used in the absorption calculation, individual incorporation fractions and the relevant location in the IAEA method
Conditions for verification
Identify the 80% assumption and the unverified individual fractions, distinguishing methodological explanation from clinical outcome data.
Requirement and applicability
Required
Application exceptions
The IAEA methods explanation is neither an individual measurement in participants in 3115 nor a new replication trial.
Why this condition is needed
Needed to avoid turning a model assumption into an identical incorporation rate actually measured in every participant.
Referenced methods
E03: M08 Table 8.2.a, M03 §3.2.4; internal application / E04: M08 §8.2.2, M15 §15.3.1; internal application / C06: M03 §3.2.4, M15 §15.3.1–15.3.3; outcome adaptation for each question is internally designed. The rationale for application to this case is to avoid turning a model assumption into an identical incorporation rate actually measured in every participant. This does not constitute new reading of full methods texts, formal application of RoB 2/GRADE/causal tools or certification of minimum clinical criteria.
N20 · Have the prespecified hierarchy and analysis plan for the selected absorption comparison been verified?
Required materials and conditions
Prespecified primary/secondary comparisons among the 6 conditions, protocol, SAP, registration history, handling of multiple comparisons and records of actual outcome changes
Conditions for verification
Separate the current page's comparison from the unverified prospective trial hierarchy, and retain the record of no adjustment for multiple comparisons.
Requirement and applicability
Required
Application exceptions
Failure to acquire a plan is not converted into proof of nonregistration or outcome switching.
Why this condition is needed
Needed to avoid promoting the page's selected main comparison to the trial's prospective primary endpoint or to evidence of no selective reporting.
Referenced methods
E06: M08 Table 8.2.a, M04 §4.6.3; internal application / C09: M04 §4.5, §4.6.3; limits on the current data transformation follow the user-defined scope and internal design / C08: M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses is internally designed. The rationale for application to this case is to avoid promoting the page's selected main comparison to the trial's prospective primary endpoint or to evidence of no selective reporting. This does not constitute new reading of full methods texts, formal application of RoB 2/GRADE/causal tools or certification of minimum clinical criteria.
N21 · What are the actual medians, IQRs and P for the two conditions?
Required materials and conditions
FIA medians, IQRs and P with/without the added 80 mg in the same 34 participants, with the corresponding table/figure and test contrast
Conditions for verification
Attribute the added condition's 26.7% (IQR 19.1–32.6%) and the no-addition condition's 20.6% (IQR 12.3–25.5%), the same 34 participants and P<0.001 to their original location.
Requirement and applicability
Required
Application exceptions
An IQR is not a confidence interval, and a significant P is not sufficient evidence of clinical importance or precision.
Why this condition is needed
Needed to preserve the positive absorption observation while keeping the different statistics represented by medians, IQRs and P distinct.
Referenced methods
C06: M03 §3.2.4, M15 §15.3.1–15.3.3; outcome adaptation for each question is internally designed / C07: M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; adaptations by design are internally designed / E04: M08 §8.2.2, M15 §15.3.1; internal application / E05: M15 §15.3.1–15.3.3; internal application. The rationale for application to this case is to preserve the positive absorption observation while keeping the different statistics represented by medians, IQRs and P distinct. This does not constitute new reading of full methods texts, formal application of RoB 2/GRADE/causal tools or certification of minimum clinical criteria.
N22 · As which estimand are 6.1%p, 1.296 and 29.6% preserved?
Required materials and conditions
Historical arithmetic records of differences/ratios of marginal medians, distinguished from individual changes and adjusted crossover effects
Conditions for verification
Preserve the historical 6.1%p, 1.296 and approximately 29.6% only as descriptive comparisons of marginal medians.
Requirement and applicability
Required
Application exceptions
Do not perform new arithmetic or reconstruct paired/standardized effects from IQR/P.
Why this condition is needed
Needed to avoid turning descriptive arithmetic on reported medians into an average individual effect or a model-adjusted estimate.
Referenced methods
C06: M03 §3.2.4, M15 §15.3.1–15.3.3; outcome adaptation for each question is internally designed / E04: M08 §8.2.2, M15 §15.3.1; internal application / E05: M15 §15.3.1–15.3.3; internal application. The rationale for application to this case is to avoid turning descriptive arithmetic on reported medians into an average individual effect or a model-adjusted estimate. This does not constitute new reading of full methods texts, formal application of RoB 2/GRADE/causal tools or certification of minimum clinical criteria.
N23 · Can the CI, SD and SE for the exact paired effect be verified?
Required materials and conditions
The paired/model-adjusted effect, CI, SD, SE, exact test statistic and analysis definition for the selected contrast
Conditions for verification
Retain the empty interval/variance values and reasons for nonverification for the current contrast, without substituting variance from another study.
Requirement and applicability
Required
Application exceptions
Absent or unverified variances/intervals are not calculated and inserted, nor interpreted as absence of an absorption direction.
Why this condition is needed
Needed to avoid filling in the current paired precision using a P-value bound and IQR, or an SD used for sample-size planning in another study.
Referenced methods
E04: M08 §8.2.2, M15 §15.3.1; internal application / E05: M15 §15.3.1–15.3.3; internal application / C07: M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; adaptations by design are internally designed. The rationale for application to this case is to avoid filling in the current paired precision using a P-value bound and IQR, or an SD used for sample-size planning in another study. This does not constitute new reading of full methods texts, formal application of RoB 2/GRADE/causal tools or certification of minimum clinical criteria.
N24 · Has the clinical meaning of the FIA difference been verified?
Required materials and conditions
A justified importance threshold for absorption itself, together with separate Hb/anemia/patient-centered outcomes and follow-up data
Conditions for verification
Distinguish the absorption observation from unverified clinical importance, and retain Hb/health questions as separate endpoints.
Requirement and applicability
Supplementary; required for extension to clinical benefit
Application exceptions
Do not require an anemia-event trial for the narrow absorption question or invent a common numerical MCID.
Why this condition is needed
Needed to avoid automatically extending the direction of a short-term physiological surrogate to anemia treatment or improvement in fatigue/health.
Referenced methods
E05: M15 §15.3.1–15.3.3; internal application / E09: M03 §3.2.4; internally defined limits on extrapolation / C01: Principles for clarifying the question in M03 §3.1, §3.2.1–3.2.4; detailed separation rules are internally designed. The rationale for application to this case is to avoid automatically extending the direction of a short-term physiological surrogate to anemia treatment or improvement in fatigue/health. This does not constitute new reading of full methods texts, formal application of RoB 2/GRADE/causal tools or certification of minimum clinical criteria.
N25 · How have the article's registration number and the probably matching mirror been distinguished?
Required materials and conditions
The printed NCT04074707 and identity of the pregnancy registration, the similar conditions/investigators/enrollment in the NCT05414474 mirror, and official version history
Conditions for verification
Identify the mismatch in the printed number and the provisional link to NCT05414474 separately, retaining the official history as unverified.
Requirement and applicability
Required
Application exceptions
Do not label failure to acquire the official history as absence of registration, or invent a link when the mirror's actual URL is unavailable.
Why this condition is needed
Needed to avoid retaining an incorrectly linked number as correct or promoting an inference from a mirror to confirmation of official prospective registration.
Referenced methods
C02: Distinction between studies and reports in M04 §4.6.1–4.6.2; cohort/outcome linkage is an internal application / C08: M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses is internally designed / C09: M04 §4.5, §4.6.3; limits on the current data transformation follow the user-defined scope and internal design / E06: M08 Table 8.2.a, M04 §4.6.3; internal application. The rationale for application to this case is to avoid retaining an incorrectly linked number as correct or promoting an inference from a mirror to confirmation of official prospective registration. This does not constitute new reading of full methods texts, formal application of RoB 2/GRADE/causal tools or certification of minimum clinical criteria.
N26 · Have conflicts involving recruitment, blood sampling, registration criteria and secondary results been preserved?
Required materials and conditions
Pairs of original records for recruitment year, final blood-sampling day, registration criteria, coffee P and the reference median, with evidence of correction/resolution
Conditions for verification
Identify the retained types of conflict and their scope, leaving unverified any parts lacking both original values/locations.
Requirement and applicability
Required
Application exceptions
Do not treat every difference in values across conditions as a conflict. Do not add counterpart values for conflicts when they are absent from the current original stored summary.
Why this condition is needed
Needed to avoid erasing historical discrepancies by choosing a statement from a single source or inventing a currently unavailable counterpart value.
Referenced methods
C08: M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses is internally designed / E06: M08 Table 8.2.a, M04 §4.6.3; internal application / C09: M04 §4.5, §4.6.3; limits on the current data transformation follow the user-defined scope and internal design. The rationale for application to this case is to avoid erasing historical discrepancies by choosing a statement from a single source or inventing a currently unavailable counterpart value. This does not constitute new reading of full methods texts, formal application of RoB 2/GRADE/causal tools or certification of minimum clinical criteria.
N27 · What is the actual acquisition scope for S1, S2 and the supplementary material?
Required materials and conditions
Corrected DOCX URL, original S1/S2 tables, content/version and actual access/acquisition records
Conditions for verification
Preserve the actual download URL, past failure and unverified S1/S2, keeping the current material type marked as not read.
Requirement and applicability
Required
Application exceptions
The 403 on 2026-09-16 is a historical failure. External access not attempted this time is not marked as current inaccessibility.
Why this condition is needed
Needed to avoid treating appendix references and link correction as verification of appendix content.
Referenced methods
C03: Principles for data collection/selection in M04 §4.5–4.6; separation of access from reading and the hyperlink contract are internally designed / E04: M08 §8.2.2, M15 §15.3.1; internal application / E06: M08 Table 8.2.a, M04 §4.6.3; internal application. The rationale for application to this case is to avoid treating appendix references and link correction as verification of appendix content. This does not constitute new reading of full methods texts, formal application of RoB 2/GRADE/causal tools or certification of minimum clinical criteria.
N28 · Can the findings be extended to the 500 mg comparison or juice alone?
Required materials and conditions
Actual contrasts, variances/intervals for 500 mg versus 80 mg/water, and whether orange juice alone was measured separately
Conditions for verification
Attribute P=0.226 for 500 mg to its corresponding contrast, without interpreting it as equivalence, an optimal dose or an effect of juice alone.
Requirement and applicability
Supplementary; required for extension to dose/juice claims
Application exceptions
Do not require trials of every dose for the narrow 80 mg main comparison.
Why this condition is needed
Needed to avoid turning an unverified additional increase into equivalence/an optimal dose or inventing an unmeasured juice effect.
Referenced methods
E08: M03 §3.2.1–3.2.4; details of dose, duration and effect modification are internally designed / C08: M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses is internally designed / E05: M15 §15.3.1–15.3.3; internal application. The rationale for application to this case is to avoid turning an unverified additional increase into equivalence/an optimal dose or inventing an unmeasured juice effect. This does not constitute new reading of full methods texts, formal application of RoB 2/GRADE/causal tools or certification of minimum clinical criteria.
N29 · Have secondary comparisons involving meals, coffee, timing and similar factors been kept separate from the main comparison?
Required materials and conditions
Actual compositions, times and endpoint contrasts for the same trial's 6 conditions, and original records of conflicts in coffee P/reference medians
Conditions for verification
Separate the two selected conditions from other contrasts, leaving unavailable secondary results within the bibliographic/reference scope.
Requirement and applicability
Required
Application exceptions
The current input only references other_conditions.json; it was not opened. No secondary-condition numbers or counterpart values for conflicts are filled in.
Why this condition is needed
Needed to avoid merging every contrast in the same trial into an identical effect or independent replication of adding AA 80 mg in the fasted state.
Referenced methods
C05: M03 §3.2.2–3.2.3; reverse-direction labeling and adaptation for testing are internally designed / C06: M03 §3.2.4, M15 §15.3.1–15.3.3; outcome adaptation for each question is internally designed / C08: M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses is internally designed / E07: M04 §4.6.1–4.6.2, M15 §15.3.1; internal application. The rationale for application to this case is to avoid merging every contrast in the same trial into an identical effect or independent replication of adding AA 80 mg in the fasted state. This does not constitute new reading of full methods texts, formal application of RoB 2/GRADE/causal tools or certification of minimum clinical criteria.
N30 · What roles do the long-term balance, dietary and nonsimultaneous-administration studies in S05–S08 play?
Required materials and conditions
Each study's actual population, diet/simultaneous exposure, absorption/balance endpoint, timing and original results/denominators
Conditions for verification
Retain S05–S08 as related material, while explaining how their conditions/measures differ from the same fasted-capsule comparison with simultaneous 80 mg administration.
Requirement and applicability
Required
Application exceptions
Do not reconstruct unprovided numbers, effects or durations from bibliographic entries that only reference sources.json.
Why this condition is needed
Needed to avoid merging null findings from other dietary/long-term balance studies into direct refutation of the main comparison, or counting them as direct replications from titles alone.
Referenced methods
E07: M04 §4.6.1–4.6.2, M15 §15.3.1; internal application / C05: M03 §3.2.2–3.2.3; reverse-direction labeling and adaptation for testing are internally designed / C06: M03 §3.2.4, M15 §15.3.1–15.3.3; outcome adaptation for each question is internally designed / C08: M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses is internally designed. The rationale for application to this case is to avoid merging null findings from other dietary/long-term balance studies into direct refutation of the main comparison, or counting them as direct replications from titles alone. This does not constitute new reading of full methods texts, formal application of RoB 2/GRADE/causal tools or certification of minimum clinical criteria.
N31 · Can S09–S12 and S21 be combined as effects for the same main comparison?
Required materials and conditions
Actual ingredients/populations/measures and results in studies of overweight/obesity or inflammation, food fortification/phytase/Na2EDTA, and iron dosing schedules
Conditions for verification
Identify each bibliographic entry's different population/intervention/endpoint, without automatically adding it to the count of directly eligible families.
Requirement and applicability
Required
Application exceptions
Do not claim verification of a full text or direct result solely from S11's title and methods citation or S12's publication timing.
Why this condition is needed
Needed to avoid turning results from other populations, combined compositions, iron schedules or hematological outcomes into direct absorption replications of single-ingredient AA addition.
Referenced methods
C04: M03 §3.2.1; detailed population criteria are internally designed / C05: M03 §3.2.2–3.2.3; reverse-direction labeling and adaptation for testing are internally designed / C06: M03 §3.2.4, M15 §15.3.1–15.3.3; outcome adaptation for each question is internally designed / E07: M04 §4.6.1–4.6.2, M15 §15.3.1; internal application. The rationale for application to this case is to avoid turning results from other populations, combined compositions, iron schedules or hematological outcomes into direct absorption replications of single-ingredient AA addition. This does not constitute new reading of full methods texts, formal application of RoB 2/GRADE/causal tools or certification of minimum clinical criteria.
N32 · Has discovery of registrations/reviews in S18–S20 been treated as verification of results?
Required materials and conditions
Actual result status in the INSECTE registration, the included-trial table in the fruit/juice review, and the exact FeHydroA registration URL and original results
Conditions for verification
Retain the level of plan/index/review discovery, distinguishing the absence of results, included-trial information or a confirmed URL.
Requirement and applicability
Required
Application exceptions
When an exact URL is unverified, do not attach a portal homepage as though it were the link to the specific original record.
Why this condition is needed
Needed to avoid promoting registered plans, review discovery or unresolved search leads to independent positive/no-difference absorption trials.
Referenced methods
C02: Distinction between studies and reports in M04 §4.6.1–4.6.2; cohort/outcome linkage is an internal application / C03: Principles for data collection/selection in M04 §4.5–4.6; separation of access from reading and the hyperlink contract are internally designed / C09: M04 §4.5, §4.6.3; limits on the current data transformation follow the user-defined scope and internal design / E06: M08 Table 8.2.a, M04 §4.6.3; internal application / E07: M04 §4.6.1–4.6.2, M15 §15.3.1; internal application. The rationale for application to this case is to avoid promoting registered plans, review discovery or unresolved search leads to independent positive/no-difference absorption trials. This does not constitute new reading of full methods texts, formal application of RoB 2/GRADE/causal tools or certification of minimum clinical criteria.
N33 · What is the verification scope for ETH funding, product supply and conflicts of interest?
Required materials and conditions
Actual records of ETH Zurich Laboratory of Human Nutrition funding, declarations of competing financial interests, product supply and institutional/author relationships
Conditions for verification
Distinguish reported funding/declarations from unreported product supply, retaining relationships that remain unverified.
Requirement and applicability
Required
Application exceptions
The existing I2 axis is preserved as a historical value, without being used as a new independence grade or certification of replication across families.
Why this condition is needed
Needed to avoid treating academic funding/a declaration of no competing interests as proof of complete independence or absence of bias, or inferring sponsorship from a brand name.
Referenced methods
C10: Chamgap's own independence/attribution criteria. The formal methods sections used in this pilot do not endorse every detail of this item / C02: Distinction between studies and reports in M04 §4.6.1–4.6.2; cohort/outcome linkage is an internal application. The rationale for application to this case is to avoid treating academic funding/a declaration of no competing interests as proof of complete independence or absence of bias, or inferring sponsorship from a brand name. This does not constitute new reading of full methods texts, formal application of RoB 2/GRADE/causal tools or certification of minimum clinical criteria.
N34 · Can adverse reactions and withdrawal frequencies under the same conditions be verified?
Required materials and conditions
Condition-specific AE definitions, collection methods, numbers of exposed people/people with events, event counts and periods, and the condition/causal attribution of the fasting-related withdrawal
Conditions for verification
Separate the record of AEs not reported from the withdrawal reason/unverified condition, without newly calculating incidence or establishing causality.
Requirement and applicability
Supplementary; required for extension to comparative harms/safety
Application exceptions
Do not arbitrarily classify the 1 withdrawal due to difficulty maintaining the fast as vitamin C harm or as 0 events.
Why this condition is needed
Needed to avoid turning positive absorption findings or unreported condition-specific AEs into absence of adverse effects or proof of safety.
Referenced methods
E10: M19 §19.1.2–19.2.4; internal application / H01: M19 §19.1.2–19.2.4; detailed distinctions are internally designed / H02: Design-specific harms questions in M19 §19.2; temporal-relationship details are internally designed / H03: M19 §19.2.2–19.2.4, M03 §3.2.3; internal application / H04: M19 §19.1.2–19.2.4; internal application / H06: M19 §19.1.2–19.2.4, M04 §4.6.3; internal application / H09: Chamgap's own interpretive boundaries. These reference M19 principles and do not constitute formal application of a causality tool. The rationale for application to this case is to avoid turning positive absorption findings or unreported condition-specific AEs into absence of adverse effects or proof of safety. This does not constitute new reading of full methods texts, formal application of RoB 2/GRADE/causal tools or certification of minimum clinical criteria.
N35 · Which safety questions do the NIH, NIDDK and NCI materials address?
Required materials and conditions
Scope of the UL of 2,000 mg/day for adults aged 19 years and older, caution concerning iron overload, the high-dose intravenous/G6PD context and the actual route/dose
Conditions for verification
Separate the actual population, route/dose and general background role of each official source.
Requirement and applicability
Supplementary; required for extension to individual/vulnerable-group safety
Application exceptions
The UL is neither an individual's recommended intake nor a guarantee of unrestricted safety, and the same adult threshold is not extended to age 18.
Why this condition is needed
Needed to avoid promoting official general safety background to individual safety or event incidence in this 80 mg oral trial.
Referenced methods
E10: M19 §19.1.2–19.2.4; internal application / H05: Design considerations in M19 §19.2.2–19.2.4; detailed confounding records are internally designed / H08: M19 §19.1.2–19.2.4; internal application / H09: Chamgap's own interpretive boundaries. These reference M19 principles and do not constitute formal application of a causality tool / C04: M03 §3.2.1; detailed population criteria are internally designed / C05: M03 §3.2.2–3.2.3; reverse-direction labeling and adaptation for testing are internally designed. The rationale for application to this case is to avoid promoting official general safety background to individual safety or event incidence in this 80 mg oral trial. This does not constitute new reading of full methods texts, formal application of RoB 2/GRADE/causal tools or certification of minimum clinical criteria.
N36 · Can the same effect be applied to other populations, durations and health endpoints?
Required materials and conditions
Direct data for men, older people, normal iron stores, anemia, pregnancy/lactation, children, renal disease/inflammation/iron overload and long-term/health endpoints
Conditions for verification
Distinguish the original population/single-exposure FIA from unverified direct evidence for excluded populations and long-term/clinical endpoints.
Requirement and applicability
Supplementary; required for extended claims
Application exceptions
Trials for each extension question are not required to complete the narrow main comparison, and these questions are not converted into a general absence of evidence or an effect of 0.
Why this condition is needed
Needed to avoid extending an acute surrogate in a limited population of young nonanemic women to health benefit or safety for everyone.
Referenced methods
C04: M03 §3.2.1; detailed population criteria are internally designed / E08: M03 §3.2.1–3.2.4; details of dose, duration and effect modification are internally designed / E09: M03 §3.2.4; internally defined limits on extrapolation / H08: M19 §19.1.2–19.2.4; internal application. The rationale for application to this case is to avoid extending an acute surrogate in a limited population of young nonanemic women to health benefit or safety for everyone. This does not constitute new reading of full methods texts, formal application of RoB 2/GRADE/causal tools or certification of minimum clinical criteria.
N37 · Have the original C/50, Caution and axes been kept from being reused as new criterion statuses?
Required materials and conditions
Separation of historical values for the original grade, score, safety, axes, document quality and assessment calculations from the new row statuses
Conditions for verification
Preserve the original assessment, axes and historical calculations unchanged, and let new criterion statuses represent only individual record/gap review.
Requirement and applicability
Required
Application exceptions
The original grade and numbers are neither deleted nor regraded. document_quality A and efficacy C are different original fields.
Why this condition is needed
Needed to avoid arbitrarily introducing n<200 or other existing scoring rules as new sufficiency criteria, or converting them into a criterion-fulfillment rate or clinical certification.
Referenced methods
C09: M04 §4.5, §4.6.3; limits on the current data transformation follow the user-defined scope and internal design / E05: M15 §15.3.1–15.3.3; internal application / H09: Chamgap's own interpretive boundaries. These reference M19 principles and do not constitute formal application of a causality tool. The rationale for application to this case is to avoid arbitrarily introducing n<200 or other existing scoring rules as new sufficiency criteria, or converting them into a criterion-fulfillment rate or clinical certification. This does not constitute new reading of full methods texts, formal application of RoB 2/GRADE/causal tools or certification of minimum clinical criteria.
N38 · Have this table's input, criterion freeze, application and verification scope been recorded?
Required materials and conditions
The 2026-09-16 evidence cutoff and search scope at that time; the actual 2026-10-05 review, original bytes/SHA, and records of criteria frozen before application
Conditions for verification
Link criterion versions/hashes with actual freeze→record→application→writing times, explicitly stating the scope and absence of new work.
Requirement and applicability
Required
Application exceptions
These are internally developed criteria for a development case already read. The 59 searches and 1 failure are historical records, not new searches in this work.
Why this condition is needed
Needed to avoid overstating transformation of the stored summary as an up-to-date comprehensive search, clinical preregistration, methodological certification or completed deployment.
Referenced methods
C03: Principles for data collection/selection in M04 §4.5–4.6; separation of access from reading and the hyperlink contract are internally designed / C09: M04 §4.5, §4.6.3; limits on the current data transformation follow the user-defined scope and internal design / C01: Principles for clarifying the question in M03 §3.1, §3.2.1–3.2.4; detailed separation rules are internally designed. The rationale for application to this case is to avoid overstating transformation of the stored summary as an up-to-date comprehensive search, clinical preregistration, methodological certification or completed deployment. This does not constitute new reading of full methods texts, formal application of RoB 2/GRADE/causal tools or certification of minimum clinical criteria.
Referenced methods and the sections actually reviewed

M03 · Cochrane Handbook 6.5 (2024), chapter updated 2023-08

Official methodology · §3.1, §3.2.1–3.2.3, MECIR C5/C7/C13

Referenced principle
Clearly record the question, eligibility criteria and reasons for changes, and distinguish variations in the intervention.
Extent of review
Historical reuse of the 5 actual methods HTML copies/SHAs for 1585 and the principles recorded at that time. This is not new reading of full methods texts or formal application/certification.

M04 · Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03

Official methodology · §4.5, §4.6.1–4.6.3, MECIR C42

Referenced principle
Distinguish and link studies and reports, and do not omit a study solely because its outcomes are not reported.
Extent of review
Historical reuse of the 5 actual methods HTML copies/SHAs for 1585 and the principles recorded at that time. This is not new reading of full methods texts or formal application/certification.

M08 · Cochrane Handbook 6.5 (2024), chapter updated 2019-10

Official methodology · §8.1–8.2.3, Table 8.2.a

Referenced principle
Hold the outcome and effect of interest fixed, then assess randomization, deviations, missing data, measurement and selective reporting.
Extent of review
Historical reuse of the 5 actual methods HTML copies/SHAs for 1585 and the principles recorded at that time. This is not new reading of full methods texts or formal application/certification.

M15 · Cochrane Handbook 6.5 (2024), chapter updated 2023-08

Official methodology · §15.2.4, §15.3.1–15.3.3

Referenced principle
Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.
Extent of review
Historical reuse of the 5 actual methods HTML copies/SHAs for 1585 and the principles recorded at that time. This is not new reading of full methods texts or formal application/certification.

M19 · Cochrane Handbook 6.5 (2024), chapter updated 2019-10

Official methodology · §19.1.2, §19.2.1–19.2.4

Referenced principle
Questions about harms may require designs, populations and follow-up different from efficacy questions. Case reports do not establish incidence.
Extent of review
Historical reuse of the 5 actual methods HTML copies/SHAs for 1585 and the principles recorded at that time. This is not new reading of full methods texts or formal application/certification.
What the statuses mean
Met
Fulfillment of narrow documentation criteria, such as question/attribution, historical calculations, current versus past reading and versions. This is not clinical efficacy/safety certification or current verification of external full texts.
Partly verified
Actual retained reports exist, but verification of the relevant material remains outstanding, including original methods/plans, denominators/intervals and identity/access checks.
Unverified
Necessary materials/values cannot be established within the current input and the scope of verification at that time. This does not mean absence of new studies or an effect of 0.
Not reported
Limited to a record of nonreporting in a specific material/section actually read or in an explicitly identified historical summary. It is not extended to the entirety of external full texts not read this time.
Conflicting information
Incompatible records of the same fact retained in the current input. Here, these concern historical conflicts involving registration numbers and QA04, not a new cross-check or resolution against original texts.
Inaccessible
Used only when external access has actually failed this time. Because access is not attempted in this work, historical 403/failure records are not inherited as current status.
Review incomplete
Limited to review that actually remains outstanding or external materials not cross-checked this time. It does not mark all review of the retained stored summary as incomplete when that review has already been completed.
Not applicable
Confirmation for other populations, long-term use, clinical outcomes or individual safety does not apply to this table's narrow FIA question. This does not constitute absence of research, a null effect or safety certification for each extension.

Change history

2026-11-06 · Public page/material version 1.0

Public-facing display and data were produced from the existing 38 items. No new clinical searches, verification-status changes or scoring were performed.

The stored-material review date (2026-10-05) and original evidence cut-off (2026-09-16) were retained unchanged.

Researcher downloads

These materials provide the same evidence, scope and verification status as this page.

View all item details

N01 · Which iron absorption comparison does this table address?

Current findings
The original claim is ‘isotope-measured fractional iron absorption in nonanemic women with low iron stores.’ It compares addition of 80 mg of single-ingredient L-ascorbic acid with an identical fasted oral iron-and-water control. Anemia treatment, fatigue, vitality and Hb recovery in 907 are separate questions.
Verification status
Met
Materials actually read
Summary read: the actual locations and values in the designated source's stored summary were read. Access to the external material types was not attempted this time; they were neither acquired nor read.
Why unverified
The identity of the question and its exclusion boundaries have been linked to the current manuscript. This does not mean that a clinical treatment effect or suitability for an individual's use has been verified.
Reason for missing information
The boundaries of the independent question have been documented. The exact paired effect and clinical benefit remain unverified in other rows.
Required materials and conditions
Identity of the question: nonanemic women with low iron stores, oral single-ingredient L-ascorbic acid, an identical-iron comparator and isotope-measured fractional iron absorption
Materials to obtain first
Identity of the question: nonanemic women with low iron stores, oral single-ingredient L-ascorbic acid, an identical-iron comparator and isotope-measured fractional iron absorption
Further research
Cross-check the original claim, population, exposure, comparator and endpoint to document included/excluded questions and the different Hb endpoint in 907.
Remaining uncertainty
The boundaries of the independent question have been documented. The exact paired effect and clinical benefit remain unverified in other rows. This limitation applies only to the current input and the scope of verification at that time; it does not mean absence of new studies, an effect of 0, safety certification or failed external access this time.
Conditions for verification
Preserve the exact /ko/effect and link the scope to the single comparison adding 80 mg to the same fasted iron exposure.
Why this condition is needed
Needed to avoid merging this absorption question with anemia-treatment assessment 907, which involves the same ingredient and route, or with the energy classification.
Application exceptions
The subclaims array is empty. No additional main table is created for anemia treatment, Hb recovery, fatigue or long-term health effects.
Referenced methods
C01: Principles for clarifying the question in M03 §3.1, §3.2.1–3.2.4; detailed separation rules are internally designed / C04: M03 §3.2.1; detailed population criteria are internally designed / C05: M03 §3.2.2–3.2.3; reverse-direction labeling and adaptation for testing are internally designed / C06: M03 §3.2.4, M15 §15.3.1–15.3.3; outcome adaptation for each question is internally designed / E09: M03 §3.2.4; internally defined limits on extrapolation. The rationale for application to this case is to avoid merging this absorption question with anemia-treatment assessment 907, which involves the same ingredient and route, or with the energy classification. This does not constitute new reading of full methods texts, formal application of RoB 2/GRADE/causal tools or certification of minimum clinical criteria.

Related sources S01 P907

N02 · To which article is the main absorption result attributed?

Current findings
S01 is the 2023 Am J Hematol article by von Siebenthal and colleagues. The PubMed identity in S02 has the same DOI and PMID. The current main-trial summary is attributed to Methods 2.1–2.5 and Results 3/Figure 2A in S01.
Verification status
Met
Materials actually read
Summary read: the actual locations and values in the designated source's stored summary were read. Access to the external material types was not attempted this time; they were neither acquired nor read.
Why unverified
The bibliography and attribution of the main-trial summary agree within the current stored summary. The external publisher site and PubMed were not opened this time.
Reason for missing information
The original article's full text and original tables/figures have not been cross-checked again in the current work.
Required materials and conditions
Link between the stored summary and the title, DOI, PMID and Methods/Results locations of the von Siebenthal 2023 article
Materials to obtain first
Link between the stored summary and the title, DOI, PMID and Methods/Results locations of the von Siebenthal 2023 article
Further research
Cross-check the article identity and citation locations, keeping the roles of other outcomes/cited reports separate.
Remaining uncertainty
The original article's full text and original tables/figures have not been cross-checked again in the current work. This limitation applies only to the current input and the scope of verification at that time; it does not mean absence of new studies, an effect of 0, safety certification or failed external access this time.
Conditions for verification
Link the DOI 10.1002/ajh.26987, PMID 37357807 and main-result locations in S01 and S02 to the same article.
Why this condition is needed
Needed to avoid interpreting ‘iron deficient’ in the bibliographic title as anemia-treatment evidence extending beyond the current population with Hb >12 g/dL.
Application exceptions
Verification of bibliographic agreement does not replace rereading the full text or certification of original-data accuracy.
Referenced methods
C02: Distinction between studies and reports in M04 §4.6.1–4.6.2; cohort/outcome linkage is an internal application / C03: Principles for data collection/selection in M04 §4.5–4.6; separation of access from reading and the hyperlink contract are internally designed / C06: M03 §3.2.4, M15 §15.3.1–15.3.3; outcome adaptation for each question is internally designed. The rationale for application to this case is to avoid interpreting ‘iron deficient’ in the bibliographic title as anemia-treatment evidence extending beyond the current population with Hb >12 g/dL. This does not constitute new reading of full methods texts, formal application of RoB 2/GRADE/causal tools or certification of minimum clinical criteria.

Related sources S01 S02

N03 · Are the 22 bibliographic entries being kept distinct from independent absorption trials?

Current findings
There are 22 bibliographic entries: S01–S21 and P907. S01/S02/S03 belong to the same article family: main text, index and supplementary material. S17 reflects a historical inference that it is probably the registration for the same trial. The 1 directly eligible family in the original evidence_status reflects the verification scope at that time; other bibliographic entries are not added as independent direct trials.
Verification status
Partly verified
Materials actually read
Summary read: the actual locations and values in the designated source's stored summary were read. Access to the external material types was not attempted this time; they were neither acquired nor read.
Why unverified
The same-article family and material types have been distinguished. The official link for S17 and the complete identities of unique cohorts in other reports cannot be established from the current input alone.
Reason for missing information
Official registration linkage and a mapping of unique trials/cohorts in the related articles
Required materials and conditions
The same-article relationship of S01/S02/S03, the provisional registration link in S17 and the roles of each related article, official explanatory source, registration and 907
Materials to obtain first
The same-article relationship of S01/S02/S03, the provisional registration link in S17 and the roles of each related article, official explanatory source, registration and 907
Further research
Cross-check the DOI, registration, population/schedule and included-trial tables across all reports to audit family duplication and unverified relationships.
Remaining uncertainty
Official registration linkage and a mapping of unique trials/cohorts in the related articles. This limitation applies only to the current input and the scope of verification at that time; it does not mean absence of new studies, an effect of 0, safety certification or failed external access this time.
Conditions for verification
Identify verified reports belonging to the same family and provisional/unverified links, distinguishing the bibliographic count from the number of direct trials.
Why this condition is needed
Needed to prevent an article's main text, index and appendix, safety explanations and registration clues from being double-counted as separate direct replications.
Application exceptions
Because sources and trial_families are absent from the current stored summary, no new definitive count of unique families for other cohorts is made.
Referenced methods
C02: Distinction between studies and reports in M04 §4.6.1–4.6.2; cohort/outcome linkage is an internal application / E07: M04 §4.6.1–4.6.2, M15 §15.3.1; internal application / H07: M04 §4.6.1–4.6.2; adaptation for harms material is internally designed. The rationale for application to this case is to prevent an article's main text, index and appendix, safety explanations and registration clues from being double-counted as separate direct replications. This does not constitute new reading of full methods texts, formal application of RoB 2/GRADE/causal tools or certification of minimum clinical criteria.

Related sources S01 S02 S03 S17 P907

N04 · Have materials actually read now been distinguished from full texts read in the past?

Current findings
The current retained KO 16 fields, structured evidence, 22 bibliographic entries, assessment and gap/correction records were read. The original assessment records past verification of the full S01 HTML and official index/safety materials. The content referenced in sources.json, the old ZIP and external materials were not opened this time; all external material types remain unread.
Verification status
Met
Materials actually read
Summary read: the actual locations and values in the designated source's stored summary were read. Access to the external material types was not attempted this time; they were neither acquired nor read.
Why unverified
Actual summary reading has been distinguished from past full-text/partial access and current access not attempted. No new verification of full-text content is claimed.
Reason for missing information
No current cross-check of external original articles, appendices, registration histories or similar materials has been performed.
Required materials and conditions
Sections, bibliography and dates actually read in the current source's stored summary; historical HTML/index/mirror/failure records; and current status by external material type
Materials to obtain first
Sections, bibliography and dates actually read in the current source's stored summary; historical HTML/index/mirror/failure records; and current status by external material type
Further research
Audit the current input scope and the access/acquisition/reading history by material type, and update separately only when an actual new reading event occurs.
Remaining uncertainty
No current cross-check of external original articles, appendices, registration histories or similar materials has been performed. This limitation applies only to the current input and the scope of verification at that time; it does not mean absence of new studies, an effect of 0, safety certification or failed external access this time.
Conditions for verification
Separate reading of the current stored summary from external access not attempted/materials not acquired/not read, and attach only links appropriate to each material type.
Why this condition is needed
Needed to avoid treating past verification or the existence of an original-source URL as external full-text reading performed this time.
Application exceptions
Preserve the past supplementary-material 403 and failed registration-history access as historical records, without labeling them as current inaccessibility.
Referenced methods
C03: Principles for data collection/selection in M04 §4.5–4.6; separation of access from reading and the hyperlink contract are internally designed / C09: M04 §4.5, §4.6.3; limits on the current data transformation follow the user-defined scope and internal design. The rationale for application to this case is to avoid treating past verification or the existence of an original-source URL as external full-text reading performed this time. This does not constitute new reading of full methods texts, formal application of RoB 2/GRADE/causal tools or certification of minimum clinical criteria.

Related sources S01 S03 S04 S17

N05 · What were the actual population's iron stores, anemia status and selection criteria?

Current findings
The population comprises nonpregnant, nonlactating women aged 18–45 years with ferritin ≤30 μg/L, Hb >12 g/dL and CRP <5 mg/L. The retained criteria also specify BMI 18.5–26.5 kg/m², body weight <70 kg and no major chronic disease. This is not classified as a treatment trial in women with anemia.
Verification status
Partly verified
Materials actually read
Summary read: the actual locations and values in the designated source's stored summary were read. Access to the external material types was not attempted this time; they were neither acquired nor read.
Why unverified
The claim's population has been linked to the retained selection criteria. Verification against original data remains outstanding for actual baseline distributions, recruitment representativeness and differences from the registration criteria.
Reason for missing information
Cross-check of baseline characteristics/recruitment distributions and official registration criteria against original data
Required materials and conditions
Criteria for the women's age, pregnancy/lactation, ferritin, Hb, CRP, BMI, weight and disease status, together with baseline characteristics/selection flow
Materials to obtain first
Criteria for the women's age, pregnancy/lactation, ferritin, Hb, CRP, BMI, weight and disease status, together with baseline characteristics/selection flow
Further research
Cross-check inclusion/exclusion criteria, the baseline-characteristics table and recruitment flow to examine the actual analyzed population and scope of generalization.
Remaining uncertainty
Cross-check of baseline characteristics/recruitment distributions and official registration criteria against original data. This limitation applies only to the current input and the scope of verification at that time; it does not mean absence of new studies, an effect of 0, safety certification or failed external access this time.
Conditions for verification
Link ferritin ≤30 μg/L, Hb >12 g/dL and the other criteria for the actual nonpregnant, nonlactating women aged 18–45 years to the limits of applicability.
Why this condition is needed
Needed to avoid equating low iron stores with confirmed anemia or with all iron-deficient populations.
Application exceptions
Iron-store criteria alone do not establish vitamin C deficiency, absence of iron overload or representativeness.
Referenced methods
C04: M03 §3.2.1; detailed population criteria are internally designed / E01: M08 §8.1–8.2.3; internal application. The rationale for application to this case is to avoid equating low iron stores with confirmed anemia or with all iron-deficient populations. This does not constitute new reading of full methods texts, formal application of RoB 2/GRADE/causal tools or certification of minimum clinical criteria.

Related sources S01 S17

N06 · Can this be interpreted as an effect of correcting vitamin C deficiency or of the habitual diet?

Current findings
Baseline vitamin C status, habitual diet and total vitamin C intake are recorded as not reported in the stored summary. The current trial is not classified as a trial of vitamin C deficiency correction.
Verification status
Unverified
Materials actually read
Summary read: the actual locations and values in the designated source's stored summary were read. Access to the external material types was not attempted this time; they were neither acquired nor read.
Why unverified
The current input has no actual baseline test/intake values, so deficiency status and total exposure cannot be established. This does not constitute new verification that reporting is absent from the entire external full text.
Reason for missing information
Baseline vitamin C test values, dietary assessment and total intake
Required materials and conditions
Baseline vitamin C testing, habitual diet/total intake and whether deficiency was a selection criterion
Materials to obtain first
Baseline vitamin C testing, habitual diet/total intake and whether deficiency was a selection criterion
Further research
Cross-check baseline nutritional testing, dietary records and intake by condition to distinguish deficiency status from the contribution of the added dose.
Remaining uncertainty
Baseline vitamin C test values, dietary assessment and total intake. This limitation applies only to the current input and the scope of verification at that time; it does not mean absence of new studies, an effect of 0, safety certification or failed external access this time.
Conditions for verification
Identify the actual reporting scope for baseline vitamin C status, habitual diet and total intake, without classifying this as a deficiency trial.
Why this condition is needed
Needed to avoid recasting the absorption comparison as an effect of correcting vitamin C deficiency or of changing total dietary intake.
Application exceptions
Tests retained as not reported are not filled in as normal values or deficiency.
Referenced methods
C04: M03 §3.2.1; detailed population criteria are internally designed / C05: M03 §3.2.2–3.2.3; reverse-direction labeling and adaptation for testing are internally designed / E02: M03 §3.2.3, M08 §8.2.2–8.2.3; internal application. The rationale for application to this case is to avoid recasting the absorption comparison as an effect of correcting vitamin C deficiency or of changing total dietary intake. This does not constitute new reading of full methods texts, formal application of RoB 2/GRADE/causal tools or certification of minimum clinical criteria.

Related sources S01

N07 · Have selection boundaries relating to iron, renal status and G6PD been verified?

Current findings
Entry criteria for TSAT and renal function, and screening for iron overload and G6PD, remain in unresolved_facets. This unverified information does not justify directly applying risks from high-dose intravenous vitamin C materials to the current oral condition.
Verification status
Unverified
Materials actually read
Summary read: the actual locations and values in the designated source's stored summary were read. Access to the external material types was not attempted this time; they were neither acquired nor read.
Why unverified
Specific screening criteria/results cannot be verified from the current input. No conclusion that the individuals are safe candidates is drawn.
Reason for missing information
TSAT/renal entry criteria and iron-overload/G6PD screening records
Required materials and conditions
Entry criteria for TSAT and renal function, procedures for iron-overload and G6PD screening, and participant-specific records
Materials to obtain first
Entry criteria for TSAT and renal function, procedures for iron-overload and G6PD screening, and participant-specific records
Further research
Cross-check entry-test tables and exclusion/safety-screening records to examine the actual eligible population and separate vulnerable groups.
Remaining uncertainty
TSAT/renal entry criteria and iron-overload/G6PD screening records. This limitation applies only to the current input and the scope of verification at that time; it does not mean absence of new studies, an effect of 0, safety certification or failed external access this time.
Conditions for verification
Retain unverified information for each entry/screening record and identify boundaries for safety interpretation appropriate to the route and dose.
Why this condition is needed
Needed to avoid establishing specific screening or individual safety solely from a statement excluding major chronic diseases.
Application exceptions
The safety context of G6PD and high-dose intravenous administration is not transferred to the 80 mg oral exposure as an equivalent risk estimate.
Referenced methods
C04: M03 §3.2.1; detailed population criteria are internally designed / H05: Design considerations in M19 §19.2.2–19.2.4; detailed confounding records are internally designed / H08: M19 §19.1.2–19.2.4; internal application. The rationale for application to this case is to avoid establishing specific screening or individual safety solely from a statement excluding major chronic diseases. This does not constitute new reading of full methods texts, formal application of RoB 2/GRADE/causal tools or certification of minimum clinical criteria.

Related sources S01 S14 S15

N08 · What are the identities of the trial's vitamin C ingredient and product?

Current findings
The added ingredient is food-grade, single-ingredient L-ascorbic acid from Sigma Aldrich. Manufacturing origin, lot and exact purity are recorded as not reported in the stored summary. It is distinguished from sodium/calcium salts, juice and multinutrient products.
Verification status
Partly verified
Materials actually read
Summary read: the actual locations and values in the designated source's stored summary were read. Access to the external material types was not attempted this time; they were neither acquired nor read.
Why unverified
The active ingredient and product designation are verified, but manufacturing/batch/purity information remains outstanding. Equivalence to other formulations has not been verified.
Reason for missing information
Manufacturing origin, lot, exact purity and actual batch specifications
Required materials and conditions
Actual manufacturing origin, lot and purity of Sigma Aldrich food-grade, single-ingredient L-ascorbic acid, and its distinction from other formulations
Materials to obtain first
Actual manufacturing origin, lot and purity of Sigma Aldrich food-grade, single-ingredient L-ascorbic acid, and its distinction from other formulations
Further research
Cross-check product specifications, trial batches and ingredient records to verify a reproducible identity for the active ingredient and formulation.
Remaining uncertainty
Manufacturing origin, lot, exact purity and actual batch specifications. This limitation applies only to the current input and the scope of verification at that time; it does not mean absence of new studies, an effect of 0, safety certification or failed external access this time.
Conditions for verification
Distinguish food-grade L-ascorbic acid as a single ingredient from verified/unverified product attributes.
Why this condition is needed
Needed to avoid assuming an exposure equivalent to salts, juice or combination products solely from a trade name or the name vitamin C.
Application exceptions
Do not fill unverified manufacturing origin, lot or purity with estimates, or infer product supply/funding from a brand name.
Referenced methods
C05: M03 §3.2.2–3.2.3; reverse-direction labeling and adaptation for testing are internally designed / E02: M03 §3.2.3, M08 §8.2.2–8.2.3; internal application. The rationale for application to this case is to avoid assuming an exposure equivalent to salts, juice or combination products solely from a trade name or the name vitamin C. This does not constitute new reading of full methods texts, formal application of RoB 2/GRADE/causal tools or certification of minimum clinical criteria.

Related sources S01

N09 · By what route and in what prepared form were they administered together?

Current findings
Single-ingredient L-ascorbic acid dissolved in water was administered orally together with iron in the fasted state. The effect size is not transferred to intravenous administration, juice, foods, salts, combination products or other iron formulations.
Verification status
Met
Materials actually read
Summary read: the actual locations and values in the designated source's stored summary were read. Access to the external material types was not attempted this time; they were neither acquired nor read.
Why unverified
The criteria for documenting the actual route and excluded formulations are met. This does not verify efficacy of other formulations or safety by route.
Reason for missing information
Equivalence of other routes/formulations and actual preparation details require separate examination.
Required materials and conditions
Oral coadministration of L-ascorbic acid dissolved in water, distinguished from the iron capsule and meal/juice/intravenous conditions
Materials to obtain first
Oral coadministration of L-ascorbic acid dissolved in water, distinguished from the iron capsule and meal/juice/intravenous conditions
Further research
Cross-check preparation/administration procedures, and design separate questions and direct comparisons when examining other routes/media.
Remaining uncertainty
Equivalence of other routes/formulations and actual preparation details require separate examination. This limitation applies only to the current input and the scope of verification at that time; it does not mean absence of new studies, an effect of 0, safety certification or failed external access this time.
Conditions for verification
Identify the addition of a single-ingredient oral aqueous solution together with exposure to the same iron capsule, excluding other routes/formulations.
Why this condition is needed
Needed to avoid replacing the actual route and medium of the absorption comparison with efficacy or safety information from another route.
Application exceptions
An intravenous-administration trial is not required as direct evidence for this narrow oral condition.
Referenced methods
C05: M03 §3.2.2–3.2.3; reverse-direction labeling and adaptation for testing are internally designed / E02: M03 §3.2.3, M08 §8.2.2–8.2.3; internal application / E08: M03 §3.2.1–3.2.4; details of dose, duration and effect modification are internally designed. The rationale for application to this case is to avoid replacing the actual route and medium of the absorption comparison with efficacy or safety information from another route. This does not constitute new reading of full methods texts, formal application of RoB 2/GRADE/causal tools or certification of minimum clinical criteria.

Related sources S01 S15

N10 · How are the 100 mg capsule and the amount of isotope label distinguished?

Current findings
The same Ferrum Hausmann 100 mg Kaps is reported to contain 100 mg of elemental iron, with an isotope label of 3 mg also reported. The authors' molar ratio of 0.24:1 is preserved. Because the record states that total elemental iron including the label was not presented in a separate table, absolute absorbed iron in mg is not calculated.
Verification status
Partly verified
Materials actually read
Summary read: the actual locations and values in the designated source's stored summary were read. Access to the external material types was not attempted this time; they were neither acquired nor read.
Why unverified
The capsule amount, label amount and reported molar ratio have been linked, but the actual total elemental iron amount is unverified. No new addition or calculation of absolute absorption was performed.
Reason for missing information
Actual total elemental iron including the label and the preparation mass table
Required materials and conditions
The capsule's 100 mg of elemental iron, the reported 3 mg label, the authors' molar ratio of 0.24:1 and explicit information on actual total elemental iron
Materials to obtain first
The capsule's 100 mg of elemental iron, the reported 3 mg label, the authors' molar ratio of 0.24:1 and explicit information on actual total elemental iron
Further research
Cross-check preparation/label masses and the actual total-dose table to distinguish the different estimands for fractional and absolute amounts.
Remaining uncertainty
Actual total elemental iron including the label and the preparation mass table. This limitation applies only to the current input and the scope of verification at that time; it does not mean absence of new studies, an effect of 0, safety certification or failed external access this time.
Conditions for verification
Preserve separately the nominal capsule amount, label amount, unverified total and author-reported molar ratio.
Why this condition is needed
Needed to avoid treating the capsule amount as total exposure or arbitrarily deriving absolute absorbed mg from fractional absorption.
Application exceptions
Do not add the reported label amount to create a new total or recalculate the authors' molar ratio.
Referenced methods
C05: M03 §3.2.2–3.2.3; reverse-direction labeling and adaptation for testing are internally designed / C06: M03 §3.2.4, M15 §15.3.1–15.3.3; outcome adaptation for each question is internally designed / E04: M08 §8.2.2, M15 §15.3.1; internal application. The rationale for application to this case is to avoid treating the capsule amount as total exposure or arbitrarily deriving absolute absorbed mg from fractional absorption. This does not constitute new reading of full methods texts, formal application of RoB 2/GRADE/causal tools or certification of minimum clinical criteria.

Related sources S01 S17

N11 · Apart from the added 80 mg, are the iron and water exposures identical in the main comparison?

Current findings
The comparison concerns conditions in which the same participant takes a labeled ferrous fumarate capsule with 200 mL of water. In the main comparison, the difference is whether 80 mg of food-grade L-ascorbic acid is added. Other comparisons among the 6 conditions are not merged with these two conditions.
Verification status
Partly verified
Materials actually read
Summary read: the actual locations and values in the designated source's stored summary were read. Access to the external material types was not attempted this time; they were neither acquired nor read.
Why unverified
The retained manuscript explicitly specifies the same iron-and-water comparator. A current cross-check of the original composition table and condition-specific concomitant-treatment/adherence records remains outstanding.
Reason for missing information
Condition-specific composition, concomitant treatments/adherence and verification of actual administration
Required materials and conditions
The same participant's exposure to the same labeled iron capsule and 200 mL of water, with or without added ascorbic acid, and actual records of common concomitant treatments
Materials to obtain first
The same participant's exposure to the same labeled iron capsule and 200 mL of water, with or without added ascorbic acid, and actual records of common concomitant treatments
Further research
Cross-check the composition/common-treatment table for each dosing condition to audit the actual comparison of interest and differences in concomitant treatments/media.
Remaining uncertainty
Condition-specific composition, concomitant treatments/adherence and verification of actual administration. This limitation applies only to the current input and the scope of verification at that time; it does not mean absence of new studies, an effect of 0, safety certification or failed external access this time.
Conditions for verification
Link the selected main comparison to whether it adds only 80 mg of ascorbic acid under the same fasted iron-and-water conditions.
Why this condition is needed
Needed to distinguish the contribution of added vitamin C from other differences in iron dose, medium or concomitant treatments.
Application exceptions
Compare only the two selected conditions, without forcing all elements of the 6 different conditions into a common control.
Referenced methods
C05: M03 §3.2.2–3.2.3; reverse-direction labeling and adaptation for testing are internally designed / E02: M03 §3.2.3, M08 §8.2.2–8.2.3; internal application. The rationale for application to this case is to distinguish the contribution of added vitamin C from other differences in iron dose, medium or concomitant treatments. This does not constitute new reading of full methods texts, formal application of RoB 2/GRADE/causal tools or certification of minimum clinical criteria.

Related sources S01

N12 · What were the meal and morning dosing conditions for the absorption comparison?

Current findings
The main comparison concerns simultaneous administration of the same iron and water with vitamin C at 07:00–09:00 in the morning after an overnight fast. An identical effect size with meals has not been verified.
Verification status
Partly verified
Materials actually read
Summary read: the actual locations and values in the designated source's stored summary were read. Access to the external material types was not attempted this time; they were neither acquired nor read.
Why unverified
The nominal fasting and timing conditions are preserved. Individual adherence and corresponding effect data for other times/meals have not been cross-checked in the current work.
Reason for missing information
Fasting/timing adherence and separate comparative data for dosing after meals or at other times
Required materials and conditions
Procedures for overnight fasting, morning dosing at 07:00–09:00 and simultaneous administration, with actual adherence records by condition
Materials to obtain first
Procedures for overnight fasting, morning dosing at 07:00–09:00 and simultaneous administration, with actual adherence records by condition
Further research
Cross-check meal/administration diaries and observation records, and examine questions about dosing after meals or at different times through separate comparisons.
Remaining uncertainty
Fasting/timing adherence and separate comparative data for dosing after meals or at other times. This limitation applies only to the current input and the scope of verification at that time; it does not mean absence of new studies, an effect of 0, safety certification or failed external access this time.
Conditions for verification
Identify fasting, administration time, simultaneous administration and unverified adherence separately.
Why this condition is needed
Needed to avoid extending the result for high-dose iron in the fasted state to an identical effect size during routine use with meals.
Application exceptions
Do not arbitrarily attribute the 1 withdrawal due to difficulty adhering to fasting to a safety event or failure of a particular condition.
Referenced methods
C05: M03 §3.2.2–3.2.3; reverse-direction labeling and adaptation for testing are internally designed / E02: M03 §3.2.3, M08 §8.2.2–8.2.3; internal application / E08: M03 §3.2.1–3.2.4; details of dose, duration and effect modification are internally designed. The rationale for application to this case is to avoid extending the result for high-dose iron in the fasted state to an identical effect size during routine use with meals. This does not constitute new reading of full methods texts, formal application of RoB 2/GRADE/causal tools or certification of minimum clinical criteria.

Related sources S01

N13 · Have single-exposure absorption measurements been distinguished from the duration of long-term use?

Current findings
Each condition involves exposure 1 time, with crossover dosing on days 1·3·5·22·24·26. According to the Methods section, blood sampling occurs on days 22/43, with label-specific incorporation measured 17–21 days after each dose. The recorded conflict over the final blood-sampling day remains unresolved, and this is not interpreted as an effect of long-term use.
Verification status
Partly verified
Materials actually read
Summary read: the actual locations and values in the designated source's stored summary were read. Access to the external material types was not attempted this time; they were neither acquired nor read.
Why unverified
The Methods schedule and single exposure are preserved. The conflict with other records over the final blood-sampling day remains, so the schedule is not promoted to a definitive final schedule.
Reason for missing information
Cross-check of the conflicting final blood-sampling day across the original schedule/figures/registration history
Required materials and conditions
Dosing days 1·3·5·22·24·26 for the 6 conditions, blood sampling on days 22/43 in the Methods section, incorporation measurements 17–21 days after administration of each label and records of conflicting information
Materials to obtain first
Dosing days 1·3·5·22·24·26 for the 6 conditions, blood sampling on days 22/43 in the Methods section, incorporation measurements 17–21 days after administration of each label and records of conflicting information
Further research
Cross-check dosing/blood-sampling schedules, figures and registration history by date to verify the exposure window and label-specific observation windows.
Remaining uncertainty
Cross-check of the conflicting final blood-sampling day across the original schedule/figures/registration history. This limitation applies only to the current input and the scope of verification at that time; it does not mean absence of new studies, an effect of 0, safety certification or failed external access this time.
Conditions for verification
Separate exposure 1 time per condition from the incorporation-measurement window, linking both the Methods schedule and the unresolved schedule conflict.
Why this condition is needed
Needed to avoid turning the incorporation-observation period into a period of long-term vitamin C administration or sustained absorption effects.
Application exceptions
Preserve the Methods schedule with its source attribution, without treating it as a definitive resolution of the conflicting final blood-sampling dates.
Referenced methods
C05: M03 §3.2.2–3.2.3; reverse-direction labeling and adaptation for testing are internally designed / C06: M03 §3.2.4, M15 §15.3.1–15.3.3; outcome adaptation for each question is internally designed / E08: M03 §3.2.1–3.2.4; details of dose, duration and effect modification are internally designed / C08: M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses is internally designed. The rationale for application to this case is to avoid turning the incorporation-observation period into a period of long-term vitamin C administration or sustained absorption effects. This does not constitute new reading of full methods texts, formal application of RoB 2/GRADE/causal tools or certification of minimum clinical criteria.

Related sources S01 S17

N14 · What was the actual extent of crossover allocation and blinding?

Current findings
The study is recorded as a randomized, open-label crossover trial with a computer-generated sequence. Allocation concealment and laboratory blinding remain not reported in the retained assessment. The objectivity of the isotope method is not used as evidence that blinding was completed.
Verification status
Partly verified
Materials actually read
Summary read: the actual locations and values in the designated source's stored summary were read. Access to the external material types was not attempted this time; they were neither acquired nor read.
Why unverified
The design and sequence generation were reported, but actual information on concealment/laboratory-blinding procedures remains outstanding.
Reason for missing information
Allocation concealment, laboratory blinding and baseline/allocation records by sequence
Required materials and conditions
Computer-generated crossover sequence, allocation-concealment/laboratory-blinding/open-label procedures, and baseline/sequence data
Materials to obtain first
Computer-generated crossover sequence, allocation-concealment/laboratory-blinding/open-label procedures, and baseline/sequence data
Further research
Cross-check random-sequence generation, allocation/testing procedures and baseline data by sequence to examine allocation limitations for the selected result.
Remaining uncertainty
Allocation concealment, laboratory blinding and baseline/allocation records by sequence. This limitation applies only to the current input and the scope of verification at that time; it does not mean absence of new studies, an effect of 0, safety certification or failed external access this time.
Conditions for verification
Distinguish the actual open-label randomized crossover design and reported/unreported procedures in relation to the endpoint.
Why this condition is needed
Needed to avoid assuming that concealment, assessment blinding or allocation problems have been resolved solely because the study is described as randomized.
Application exceptions
An open-label design or unreported blinding does not automatically render the measurement invalid.
Referenced methods
E01: M08 §8.1–8.2.3; internal application / E03: M08 Table 8.2.a, M03 §3.2.4; internal application / C04: M03 §3.2.1; detailed population criteria are internally designed. The rationale for application to this case is to avoid assuming that concealment, assessment blinding or allocation problems have been resolved solely because the study is described as randomized. This does not constitute new reading of full methods texts, formal application of RoB 2/GRADE/causal tools or certification of minimum clinical criteria.

Related sources S01

N15 · Can 35 participants, 34 participants and 204 observations be distinguished?

Current findings
Of 35 enrolled participants, 34 completed all 6 conditions and were analyzed. The 204 observations are repeated observations, not 204 people. The main comparison uses the same 34 participants, whose counts are not combined as sample sizes for two independent groups.
Verification status
Partly verified
Materials actually read
Summary read: the actual locations and values in the designated source's stored summary were read. Access to the external material types was not attempted this time; they were neither acquired nor read.
Why unverified
The retained enrollment, analysis and observation denominators have been distinguished. A current cross-check of the original condition-specific missing-data/analysis flowchart remains outstanding.
Reason for missing information
Original tables of condition-specific analysis/missing measurements and participant linkage
Required materials and conditions
35 enrolled participants, 34 analyzed participants who completed the 6 conditions, 204 observations, and linkage of the same participants across the two selected conditions
Materials to obtain first
35 enrolled participants, 34 analyzed participants who completed the 6 conditions, 204 observations, and linkage of the same participants across the two selected conditions
Further research
Cross-check participant flow and condition-specific analysis tables to distinguish denominators for people, repeated observations and pairs.
Remaining uncertainty
Original tables of condition-specific analysis/missing measurements and participant linkage. This limitation applies only to the current input and the scope of verification at that time; it does not mean absence of new studies, an effect of 0, safety certification or failed external access this time.
Conditions for verification
Link the original enrollment/completion/analysis/observation counts unchanged, identifying the comparison as paired within the same 34 participants.
Why this condition is needed
Needed to avoid counting repeated observations as people or combining the same 34 participants as two independent groups.
Application exceptions
Do not turn 204 observations into 204 participants or calculate a new total participant count.
Referenced methods
C07: M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; adaptations by design are internally designed / E04: M08 §8.2.2, M15 §15.3.1; internal application. The rationale for application to this case is to avoid counting repeated observations as people or combining the same 34 participants as two independent groups. This does not constitute new reading of full methods texts, formal application of RoB 2/GRADE/causal tools or certification of minimum clinical criteria.

Related sources S01

N16 · Have the completer analysis, withdrawal and imputation records been distinguished?

Current findings
This is a per-protocol completer analysis; 1 of the 35 participants withdrew after the first visit because of difficulty maintaining the fast. The condition involved is unverified. CRP imputation in the retained assessment is a separate record from imputation of fractional iron absorption.
Verification status
Partly verified
Materials actually read
Summary read: the actual locations and values in the designated source's stored summary were read. Access to the external material types was not attempted this time; they were neither acquired nor read.
Why unverified
The reason for attrition and the analysis/imputation boundaries are preserved. The condition of withdrawal, original details of missing-data handling and analysis of all randomized participants are unverified.
Reason for missing information
Condition of withdrawal, handling of missing FIA data and definitions of assignment/adherence analyses
Required materials and conditions
Reason/condition for the 1 withdrawal after the first visit, the per-protocol completer analysis, and separate handling of CRP imputation and missing FIA data
Materials to obtain first
Reason/condition for the 1 withdrawal after the first visit, the per-protocol completer analysis, and separate handling of CRP imputation and missing FIA data
Further research
Cross-check the flow diagram, missing-data/imputation rules and analysis code to examine the distinction between effects of assignment and adherence, and the possible influence of attrition.
Remaining uncertainty
Condition of withdrawal, handling of missing FIA data and definitions of assignment/adherence analyses. This limitation applies only to the current input and the scope of verification at that time; it does not mean absence of new studies, an effect of 0, safety certification or failed external access this time.
Conditions for verification
Preserve separately the distinction between the analysis of 34 completers and enrollment of 35 participants, the imputed variable and the unverified condition of withdrawal.
Why this condition is needed
Needed to avoid treating completer results as the effect in all randomized participants or mistaking CRP imputation for absorption-rate imputation.
Application exceptions
Do not attribute the withdrawal to an adverse effect of iron or vitamin C while its condition remains unverified.
Referenced methods
C07: M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; adaptations by design are internally designed / E04: M08 §8.2.2, M15 §15.3.1; internal application / H06: M19 §19.1.2–19.2.4, M04 §4.6.3; internal application. The rationale for application to this case is to avoid treating completer results as the effect in all randomized participants or mistaking CRP imputation for absorption-rate imputation. This does not constitute new reading of full methods texts, formal application of RoB 2/GRADE/causal tools or certification of minimum clinical criteria.

Related sources S01

N17 · How were adherence and period, sequence and carryover effects handled?

Current findings
Supervised administration is recorded, but interactions involving period, sequence and carryover effects remain in unresolved_facets. A comparison within the same participants is distinguished from estimation of an adjusted crossover effect.
Verification status
Unverified
Materials actually read
Summary read: the actual locations and values in the designated source's stored summary were read. Access to the external material types was not attempted this time; they were neither acquired nor read.
Why unverified
Supervised administration alone cannot establish the actual model contrasts or handling of sequence/carryover.
Reason for missing information
Adherence records, crossover-model contrasts and period/sequence/carryover interactions
Required materials and conditions
Records of supervised administration, period/sequence/carryover effects and interactions, and definitions of the actual crossover model and contrast
Materials to obtain first
Records of supervised administration, period/sequence/carryover effects and interactions, and definitions of the actual crossover model and contrast
Further research
Cross-check administration logs, the repeated-measures model, period/sequence terms and prespecified contrasts to examine the adequacy of the crossover handling.
Remaining uncertainty
Adherence records, crossover-model contrasts and period/sequence/carryover interactions. This limitation applies only to the current input and the scope of verification at that time; it does not mean absence of new studies, an effect of 0, safety certification or failed external access this time.
Conditions for verification
Separate the reporting level for supervised administration from unverified crossover handling, and link the scope of verification for paired/adjusted effects.
Why this condition is needed
Needed to avoid assuming that time/sequence effects and all confounding were eliminated solely because the comparison was repeated within the same individuals.
Application exceptions
Unverified interactions are not treated as established carryover bias or a null effect.
Referenced methods
E02: M03 §3.2.3, M08 §8.2.2–8.2.3; internal application / E04: M08 §8.2.2, M15 §15.3.1; internal application / C06: M03 §3.2.4, M15 §15.3.1–15.3.3; outcome adaptation for each question is internally designed. The rationale for application to this case is to avoid assuming that time/sequence effects and all confounding were eliminated solely because the comparison was repeated within the same individuals. This does not constitute new reading of full methods texts, formal application of RoB 2/GRADE/causal tools or certification of minimum clinical criteria.

Related sources S01

N18 · Which test and unit define the fractional iron absorption result?

Current findings
The endpoint is FIA (%) obtained from erythrocyte incorporation of 54Fe·57Fe·58Fe and isotope dilution. The incorporation model uses measurements 17–21 days after administration of each label; blood iron concentration or an increase in Hb is not substituted for absorption.
Verification status
Partly verified
Materials actually read
Summary read: the actual locations and values in the designated source's stored summary were read. Access to the external material types was not attempted this time; they were neither acquired nor read.
Why unverified
The assay type, unit and measurement window have been linked. A current cross-check of original assay quality and actual label-specific measurements remains outstanding.
Reason for missing information
Label-specific assays/quality control and original isotope-dilution measurement data
Required materials and conditions
Erythrocyte incorporation of 54Fe·57Fe·58Fe, the dilution method, label-specific measurement windows, the definition of FIA (%) and assay quality
Materials to obtain first
Erythrocyte incorporation of 54Fe·57Fe·58Fe, the dilution method, label-specific measurement windows, the definition of FIA (%) and assay quality
Further research
Cross-check isotope assays, label-specific incorporation/dilution procedures and outcome units to examine measurement limitations of the selected endpoint.
Remaining uncertainty
Label-specific assays/quality control and original isotope-dilution measurement data. This limitation applies only to the current input and the scope of verification at that time; it does not mean absence of new studies, an effect of 0, safety certification or failed external access this time.
Conditions for verification
Link the selected endpoint to stable-isotope-derived FIA (%) and distinguish it from other iron/hemoglobin outcomes.
Why this condition is needed
Needed to avoid confusing increased blood iron, Hb recovery or ferritin changes with actual stable-isotope absorption measurements.
Application exceptions
An objective test is not converted into direct proof of clinical events/patient-centered benefit.
Referenced methods
C06: M03 §3.2.4, M15 §15.3.1–15.3.3; outcome adaptation for each question is internally designed / E03: M08 Table 8.2.a, M03 §3.2.4; internal application / E09: M03 §3.2.4; internally defined limits on extrapolation. The rationale for application to this case is to avoid confusing increased blood iron, Hb recovery or ferritin changes with actual stable-isotope absorption measurements. This does not constitute new reading of full methods texts, formal application of RoB 2/GRADE/causal tools or certification of minimum clinical criteria.

Related sources S01 S16

N19 · What does the assumption of 80% erythrocyte incorporation mean?

Current findings
Fractional iron absorption is modeled assuming 80% erythrocyte incorporation. Actual individual incorporation fractions are unverified. The IAEA methods section in S16 is historical background for the calculation principles; it neither verifies incorporation rates in these participants nor provides independent effect data.
Verification status
Partly verified
Materials actually read
Summary read: the actual locations and values in the designated source's stored summary were read. Access to the external material types was not attempted this time; they were neither acquired nor read.
Why unverified
The assumption and methodological source are preserved. Individual incorporation fractions and actual model-sensitivity data have not been verified.
Reason for missing information
Individual incorporation fractions and data for checking the applied model/assumptions
Required materials and conditions
The 80% incorporation assumption used in the absorption calculation, individual incorporation fractions and the relevant location in the IAEA method
Materials to obtain first
The 80% incorporation assumption used in the absorption calculation, individual incorporation fractions and the relevant location in the IAEA method
Further research
Cross-check the absorption model/assumptions against individual incorporation data, and examine interpretation of changes to assumptions through an appropriate prespecified analysis.
Remaining uncertainty
Individual incorporation fractions and data for checking the applied model/assumptions. This limitation applies only to the current input and the scope of verification at that time; it does not mean absence of new studies, an effect of 0, safety certification or failed external access this time.
Conditions for verification
Identify the 80% assumption and the unverified individual fractions, distinguishing methodological explanation from clinical outcome data.
Why this condition is needed
Needed to avoid turning a model assumption into an identical incorporation rate actually measured in every participant.
Application exceptions
The IAEA methods explanation is neither an individual measurement in participants in 3115 nor a new replication trial.
Referenced methods
E03: M08 Table 8.2.a, M03 §3.2.4; internal application / E04: M08 §8.2.2, M15 §15.3.1; internal application / C06: M03 §3.2.4, M15 §15.3.1–15.3.3; outcome adaptation for each question is internally designed. The rationale for application to this case is to avoid turning a model assumption into an identical incorporation rate actually measured in every participant. This does not constitute new reading of full methods texts, formal application of RoB 2/GRADE/causal tools or certification of minimum clinical criteria.

Related sources S01 S16

N20 · Have the prespecified hierarchy and analysis plan for the selected absorption comparison been verified?

Current findings
The original evidence concerns 1 main comparison selected for the page from the 6 conditions in the same participants. The official prospective endpoint hierarchy is unverified, and the retained assessment records no adjustment for multiple comparisons. This limitation alone does not establish selective reporting.
Verification status
Unverified
Materials actually read
Summary read: the actual locations and values in the designated source's stored summary were read. Access to the external material types was not attempted this time; they were neither acquired nor read.
Why unverified
The current input lacks an official prior plan/history, so prespecification of the page's comparison and the multiple-comparison plan cannot be cross-checked.
Reason for missing information
Official prospective endpoint hierarchy, protocol/SAP and multiple-comparison plan
Required materials and conditions
Prespecified primary/secondary comparisons among the 6 conditions, protocol, SAP, registration history, handling of multiple comparisons and records of actual outcome changes
Materials to obtain first
Prespecified primary/secondary comparisons among the 6 conditions, protocol, SAP, registration history, handling of multiple comparisons and records of actual outcome changes
Further research
Cross-check initial/revised registrations, the protocol, SAP and actual results for the 6 conditions to verify the endpoint/contrast hierarchy and reasons for changes.
Remaining uncertainty
Official prospective endpoint hierarchy, protocol/SAP and multiple-comparison plan. This limitation applies only to the current input and the scope of verification at that time; it does not mean absence of new studies, an effect of 0, safety certification or failed external access this time.
Conditions for verification
Separate the current page's comparison from the unverified prospective trial hierarchy, and retain the record of no adjustment for multiple comparisons.
Why this condition is needed
Needed to avoid promoting the page's selected main comparison to the trial's prospective primary endpoint or to evidence of no selective reporting.
Application exceptions
Failure to acquire a plan is not converted into proof of nonregistration or outcome switching.
Referenced methods
E06: M08 Table 8.2.a, M04 §4.6.3; internal application / C09: M04 §4.5, §4.6.3; limits on the current data transformation follow the user-defined scope and internal design / C08: M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses is internally designed. The rationale for application to this case is to avoid promoting the page's selected main comparison to the trial's prospective primary endpoint or to evidence of no selective reporting. This does not constitute new reading of full methods texts, formal application of RoB 2/GRADE/causal tools or certification of minimum clinical criteria.

Related sources S01 S04 S17

N21 · What are the actual medians, IQRs and P for the two conditions?

Current findings
With the added 80 mg, median FIA is 26.7% and the IQR is 19.1–32.6%. Without the addition, it is 20.6%, with an IQR of 12.3–25.5%; P<0.001 for the comparison in the same 34 participants is preserved. The IQR is not a CI.
Verification status
Partly verified
Materials actually read
Summary read: the actual locations and values in the designated source's stored summary were read. Access to the external material types was not attempted this time; they were neither acquired nor read.
Why unverified
The stored summary's numbers, direction and denominator have been linked. The original test contrast, paired interval and a current full-text check of the original table/figure remain outstanding.
Reason for missing information
Original table/figure, exact test contrast and paired-effect interval
Required materials and conditions
FIA medians, IQRs and P with/without the added 80 mg in the same 34 participants, with the corresponding table/figure and test contrast
Materials to obtain first
FIA medians, IQRs and P with/without the added 80 mg in the same 34 participants, with the corresponding table/figure and test contrast
Further research
Cross-check the original table/figure and test contrast to verify agreement of the reported medians, distributions, P and analysis denominator.
Remaining uncertainty
Original table/figure, exact test contrast and paired-effect interval. This limitation applies only to the current input and the scope of verification at that time; it does not mean absence of new studies, an effect of 0, safety certification or failed external access this time.
Conditions for verification
Attribute the added condition's 26.7% (IQR 19.1–32.6%) and the no-addition condition's 20.6% (IQR 12.3–25.5%), the same 34 participants and P<0.001 to their original location.
Why this condition is needed
Needed to preserve the positive absorption observation while keeping the different statistics represented by medians, IQRs and P distinct.
Application exceptions
An IQR is not a confidence interval, and a significant P is not sufficient evidence of clinical importance or precision.
Referenced methods
C06: M03 §3.2.4, M15 §15.3.1–15.3.3; outcome adaptation for each question is internally designed / C07: M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; adaptations by design are internally designed / E04: M08 §8.2.2, M15 §15.3.1; internal application / E05: M15 §15.3.1–15.3.3; internal application. The rationale for application to this case is to preserve the positive absorption observation while keeping the different statistics represented by medians, IQRs and P distinct. This does not constitute new reading of full methods texts, formal application of RoB 2/GRADE/causal tools or certification of minimum clinical criteria.

Related sources S01

N22 · As which estimand are 6.1%p, 1.296 and 29.6% preserved?

Current findings
The historical calculation record's median difference of 6.1%p, median ratio of 1.296 and approximately 29.6% higher value are descriptive comparisons of marginal medians. They are not the mean/median of individual changes or an adjusted crossover effect. No calculation was performed this time.
Verification status
Met
Materials actually read
Summary read: the actual locations and values in the designated source's stored summary were read. Access to the external material types was not attempted this time; they were neither acquired nor read.
Why unverified
The historical arithmetic's units, estimand and limits of application have been kept distinct and unchanged. No new effect size or paired confidence interval was created.
Reason for missing information
Individual paired or model-adjusted contrasts remain unverified and require separate data.
Required materials and conditions
Historical arithmetic records of differences/ratios of marginal medians, distinguished from individual changes and adjusted crossover effects
Materials to obtain first
Historical arithmetic records of differences/ratios of marginal medians, distinguished from individual changes and adjusted crossover effects
Further research
Cross-check inputs, units and estimands in the retained calculation record against the original results to distinguish descriptive arithmetic from inferential estimation.
Remaining uncertainty
Individual paired or model-adjusted contrasts remain unverified and require separate data. This limitation applies only to the current input and the scope of verification at that time; it does not mean absence of new studies, an effect of 0, safety certification or failed external access this time.
Conditions for verification
Preserve the historical 6.1%p, 1.296 and approximately 29.6% only as descriptive comparisons of marginal medians.
Why this condition is needed
Needed to avoid turning descriptive arithmetic on reported medians into an average individual effect or a model-adjusted estimate.
Application exceptions
Do not perform new arithmetic or reconstruct paired/standardized effects from IQR/P.
Referenced methods
C06: M03 §3.2.4, M15 §15.3.1–15.3.3; outcome adaptation for each question is internally designed / E04: M08 §8.2.2, M15 §15.3.1; internal application / E05: M15 §15.3.1–15.3.3; internal application. The rationale for application to this case is to avoid turning descriptive arithmetic on reported medians into an average individual effect or a model-adjusted estimate. This does not constitute new reading of full methods texts, formal application of RoB 2/GRADE/causal tools or certification of minimum clinical criteria.

Related sources S01

N23 · Can the CI, SD and SE for the exact paired effect be verified?

Current findings
The paired or model-adjusted contrast, CI, SD, SE and exact test statistic are unverified. Fields such as mean_changes, sd_changes, standard_error and interval in the original calculation structure are empty. They are not reconstructed from the IQR and P<0.001, and a planning SD from another study is not used.
Verification status
Unverified
Materials actually read
Summary read: the actual locations and values in the designated source's stored summary were read. Access to the external material types was not attempted this time; they were neither acquired nor read.
Why unverified
The current input lacks the actual variance/interval for this contrast. A significant P alone cannot establish precision or a standardized effect.
Reason for missing information
Paired/adjusted effect, variance, confidence interval and test output for the selected contrast
Required materials and conditions
The paired/model-adjusted effect, CI, SD, SE, exact test statistic and analysis definition for the selected contrast
Materials to obtain first
The paired/model-adjusted effect, CI, SD, SE, exact test statistic and analysis definition for the selected contrast
Further research
Acquire the analysis output, paired data and model SE/CI for the selected contrast, and cross-check them against the original estimand/denominator.
Remaining uncertainty
Paired/adjusted effect, variance, confidence interval and test output for the selected contrast. This limitation applies only to the current input and the scope of verification at that time; it does not mean absence of new studies, an effect of 0, safety certification or failed external access this time.
Conditions for verification
Retain the empty interval/variance values and reasons for nonverification for the current contrast, without substituting variance from another study.
Why this condition is needed
Needed to avoid filling in the current paired precision using a P-value bound and IQR, or an SD used for sample-size planning in another study.
Application exceptions
Absent or unverified variances/intervals are not calculated and inserted, nor interpreted as absence of an absorption direction.
Referenced methods
E04: M08 §8.2.2, M15 §15.3.1; internal application / E05: M15 §15.3.1–15.3.3; internal application / C07: M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; adaptations by design are internally designed. The rationale for application to this case is to avoid filling in the current paired precision using a P-value bound and IQR, or an SD used for sample-size planning in another study. This does not constitute new reading of full methods texts, formal application of RoB 2/GRADE/causal tools or certification of minimum clinical criteria.

Related sources S01 S03

N24 · Has the clinical meaning of the FIA difference been verified?

Current findings
The retained manuscript describes the direction of absorption positively, but states that clinical meaning and the exact paired magnitude are unverified. FIA is a physiological surrogate; this result does not establish anemia treatment, Hb recovery or improvement in fatigue or health.
Verification status
Unverified
Materials actually read
Summary read: the actual locations and values in the designated source's stored summary were read. Access to the external material types was not attempted this time; they were neither acquired nor read.
Why unverified
A validated threshold for clinical importance and direct clinical-benefit data for the condition have not been verified. This does not erase the FIA observation or turn it into an effect of 0.
Reason for missing information
An importance threshold for absorption and direct clinical outcome/long-term follow-up data
Required materials and conditions
A justified importance threshold for absorption itself, together with separate Hb/anemia/patient-centered outcomes and follow-up data
Materials to obtain first
A justified importance threshold for absorption itself, together with separate Hb/anemia/patient-centered outcomes and follow-up data
Further research
Examine the basis for absorption's importance and direct clinical outcomes by endpoint, designing a separate long-term clinical comparison if needed.
Remaining uncertainty
An importance threshold for absorption and direct clinical outcome/long-term follow-up data. This limitation applies only to the current input and the scope of verification at that time; it does not mean absence of new studies, an effect of 0, safety certification or failed external access this time.
Conditions for verification
Distinguish the absorption observation from unverified clinical importance, and retain Hb/health questions as separate endpoints.
Why this condition is needed
Needed to avoid automatically extending the direction of a short-term physiological surrogate to anemia treatment or improvement in fatigue/health.
Application exceptions
Do not require an anemia-event trial for the narrow absorption question or invent a common numerical MCID.
Referenced methods
E05: M15 §15.3.1–15.3.3; internal application / E09: M03 §3.2.4; internally defined limits on extrapolation / C01: Principles for clarifying the question in M03 §3.1, §3.2.1–3.2.4; detailed separation rules are internally designed. The rationale for application to this case is to avoid automatically extending the direction of a short-term physiological surrogate to anemia treatment or improvement in fatigue/health. This does not constitute new reading of full methods texts, formal application of RoB 2/GRADE/causal tools or certification of minimum clinical criteria.

Related sources S01 P907

N25 · How have the article's registration number and the probably matching mirror been distinguished?

Current findings
The record states that the printed NCT04074707 appears to concern a pregnancy study and does not match this population. NCT05414474 was provisionally linked by inference from a mirror as a probable registration with the same 6 conditions, investigators and enrollment. The historical record of inability to access the official history is preserved, without treating it as absence of registration or a confirmed link.
Verification status
Conflicting information
Materials actually read
Summary read: the actual locations and values in the designated source's stored summary were read. Access to the external material types was not attempted this time; they were neither acquired nor read.
Why unverified
The current input records a population mismatch for the printed registration number and a provisional alternative link. Without a cross-check of the official history, registration identity cannot be marked as resolved.
Reason for missing information
Official registration version history, correction of the article's registration and the actual mirror URL
Required materials and conditions
The printed NCT04074707 and identity of the pregnancy registration, the similar conditions/investigators/enrollment in the NCT05414474 mirror, and official version history
Materials to obtain first
The printed NCT04074707 and identity of the pregnancy registration, the similar conditions/investigators/enrollment in the NCT05414474 mirror, and official version history
Further research
Cross-check the official initial/revised registration history against the population, 6 conditions, investigators and enrollment in the article/mirror to verify the actual link.
Remaining uncertainty
Official registration version history, correction of the article's registration and the actual mirror URL. This limitation applies only to the current input and the scope of verification at that time; it does not mean absence of new studies, an effect of 0, safety certification or failed external access this time.
Conditions for verification
Identify the mismatch in the printed number and the provisional link to NCT05414474 separately, retaining the official history as unverified.
Why this condition is needed
Needed to avoid retaining an incorrectly linked number as correct or promoting an inference from a mirror to confirmation of official prospective registration.
Application exceptions
Do not label failure to acquire the official history as absence of registration, or invent a link when the mirror's actual URL is unavailable.
Referenced methods
C02: Distinction between studies and reports in M04 §4.6.1–4.6.2; cohort/outcome linkage is an internal application / C08: M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses is internally designed / C09: M04 §4.5, §4.6.3; limits on the current data transformation follow the user-defined scope and internal design / E06: M08 Table 8.2.a, M04 §4.6.3; internal application. The rationale for application to this case is to avoid retaining an incorrectly linked number as correct or promoting an inference from a mirror to confirmation of official prospective registration. This does not constitute new reading of full methods texts, formal application of RoB 2/GRADE/causal tools or certification of minimum clinical criteria.

Related sources S01 S04 S17

N26 · Have conflicts involving recruitment, blood sampling, registration criteria and secondary results been preserved?

Current findings
QA04 records preservation of conflicts involving recruitment year, blood-sampling day, registration criteria, coffee P values and the reference median. Because the current stored summary does not contain all original values from both sides, no counterpart year, blood-sampling day, coffee P or median is newly supplied. Blood sampling on days 22/43 in the Methods section is also retained only as that section's record.
Verification status
Conflicting information
Materials actually read
Summary read: the actual locations and values in the designated source's stored summary were read. Access to the external material types was not attempted this time; they were neither acquired nor read.
Why unverified
The historical conflict records are explicit and unresolved. The counterpart original values have not been reread in the current work, so no new confirmation or resolution of conflicts is claimed.
Reason for missing information
Original values/locations on both sides of each conflict, correction history and actual evidence of resolution
Required materials and conditions
Pairs of original records for recruitment year, final blood-sampling day, registration criteria, coffee P and the reference median, with evidence of correction/resolution
Materials to obtain first
Pairs of original records for recruitment year, final blood-sampling day, registration criteria, coffee P and the reference median, with evidence of correction/resolution
Further research
Cross-check the article's Methods, figures/results, original registration versions and correction records fact by fact, preserving incompatible pairs and the evidence for resolution.
Remaining uncertainty
Original values/locations on both sides of each conflict, correction history and actual evidence of resolution. This limitation applies only to the current input and the scope of verification at that time; it does not mean absence of new studies, an effect of 0, safety certification or failed external access this time.
Conditions for verification
Identify the retained types of conflict and their scope, leaving unverified any parts lacking both original values/locations.
Why this condition is needed
Needed to avoid erasing historical discrepancies by choosing a statement from a single source or inventing a currently unavailable counterpart value.
Application exceptions
Do not treat every difference in values across conditions as a conflict. Do not add counterpart values for conflicts when they are absent from the current original stored summary.
Referenced methods
C08: M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses is internally designed / E06: M08 Table 8.2.a, M04 §4.6.3; internal application / C09: M04 §4.5, §4.6.3; limits on the current data transformation follow the user-defined scope and internal design. The rationale for application to this case is to avoid erasing historical discrepancies by choosing a statement from a single source or inventing a currently unavailable counterpart value. This does not constitute new reading of full methods texts, formal application of RoB 2/GRADE/causal tools or certification of minimum clinical criteria.

Related sources S01 S17

N27 · What is the actual acquisition scope for S1, S2 and the supplementary material?

Current findings
S03 refers to S01's approximately 22.1 KB supplementary DOCX and S1/S2. QA06 corrected the link to the actual download URL and recorded the 403 failure at that time. External access has not been attempted in the current work; the content of S1/S2 and condition-specific analyses remain unverified.
Verification status
Unverified
Materials actually read
Summary read: the actual locations and values in the designated source's stored summary were read. Access to the external material types was not attempted this time; they were neither acquired nor read.
Why unverified
Supplementary-material content is absent from the current input, and a past acquisition failure is recorded. The existence of a link alone does not support a claim that the full text was read or the analysis verified.
Reason for missing information
Original S1/S2 tables, appendix version/bytes and actual acquisition records
Required materials and conditions
Corrected DOCX URL, original S1/S2 tables, content/version and actual access/acquisition records
Materials to obtain first
Corrected DOCX URL, original S1/S2 tables, content/version and actual access/acquisition records
Further research
Upon an authorized actual acquisition event, cross-check the DOCX version/original bytes and S1/S2 against the main-text contrasts, denominators and variances.
Remaining uncertainty
Original S1/S2 tables, appendix version/bytes and actual acquisition records. This limitation applies only to the current input and the scope of verification at that time; it does not mean absence of new studies, an effect of 0, safety certification or failed external access this time.
Conditions for verification
Preserve the actual download URL, past failure and unverified S1/S2, keeping the current material type marked as not read.
Why this condition is needed
Needed to avoid treating appendix references and link correction as verification of appendix content.
Application exceptions
The 403 on 2026-09-16 is a historical failure. External access not attempted this time is not marked as current inaccessibility.
Referenced methods
C03: Principles for data collection/selection in M04 §4.5–4.6; separation of access from reading and the hyperlink contract are internally designed / E04: M08 §8.2.2, M15 §15.3.1; internal application / E06: M08 Table 8.2.a, M04 §4.6.3; internal application. The rationale for application to this case is to avoid treating appendix references and link correction as verification of appendix content. This does not constitute new reading of full methods texts, formal application of RoB 2/GRADE/causal tools or certification of minimum clinical criteria.

Related sources S01 S03

N28 · Can the findings be extended to the 500 mg comparison or juice alone?

Current findings
The record reports P=0.226 for no verified additional increase with 500 mg over 80 mg, although absorption with the former condition was higher than with water. This does not prove equivalence or an optimal dose. The record that orange juice alone was not measured is retained.
Verification status
Partly verified
Materials actually read
Summary read: the actual locations and values in the designated source's stored summary were read. Access to the external material types was not attempted this time; they were neither acquired nor read.
Why unverified
The reported direction for the secondary dose and the limits on extrapolation are preserved. Paired intervals, an equivalence plan and a direct juice-alone comparison have not been verified.
Reason for missing information
Dose contrasts/intervals, a prespecified equivalence plan and a separate juice-alone comparison
Required materials and conditions
Actual contrasts, variances/intervals for 500 mg versus 80 mg/water, and whether orange juice alone was measured separately
Materials to obtain first
Actual contrasts, variances/intervals for 500 mg versus 80 mg/water, and whether orange juice alone was measured separately
Further research
Examine prespecified dose contrasts/intervals, and address equivalence, optimal-dose or juice-alone questions through appropriate separate direct comparisons.
Remaining uncertainty
Dose contrasts/intervals, a prespecified equivalence plan and a separate juice-alone comparison. This limitation applies only to the current input and the scope of verification at that time; it does not mean absence of new studies, an effect of 0, safety certification or failed external access this time.
Conditions for verification
Attribute P=0.226 for 500 mg to its corresponding contrast, without interpreting it as equivalence, an optimal dose or an effect of juice alone.
Why this condition is needed
Needed to avoid turning an unverified additional increase into equivalence/an optimal dose or inventing an unmeasured juice effect.
Application exceptions
Do not require trials of every dose for the narrow 80 mg main comparison.
Referenced methods
E08: M03 §3.2.1–3.2.4; details of dose, duration and effect modification are internally designed / C08: M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses is internally designed / E05: M15 §15.3.1–15.3.3; internal application. The rationale for application to this case is to avoid turning an unverified additional increase into equivalence/an optimal dose or inventing an unmeasured juice effect. This does not constitute new reading of full methods texts, formal application of RoB 2/GRADE/causal tools or certification of minimum clinical criteria.

Related sources S01

N29 · Have secondary comparisons involving meals, coffee, timing and similar factors been kept separate from the main comparison?

Current findings
The current evidence describes a crossover trial with 6 conditions and references secondary material in other_conditions.json. That separate file was not read this time. Conflicts in coffee P and the reference median are retained as QA04 records; those values are neither newly extracted nor merged into the main comparison.
Verification status
Unverified
Materials actually read
Summary read: the actual locations and values in the designated source's stored summary were read. Access to the external material types was not attempted this time; they were neither acquired nor read.
Why unverified
Detailed contrasts/numbers for secondary conditions are absent from the current stored summary, so their actual direction and counterpart values for conflicts cannot be established.
Reason for missing information
Composition/contrasts for the 6 conditions, original tables of secondary results and locations of conflicts
Required materials and conditions
Actual compositions, times and endpoint contrasts for the same trial's 6 conditions, and original records of conflicts in coffee P/reference medians
Materials to obtain first
Actual compositions, times and endpoint contrasts for the same trial's 6 conditions, and original records of conflicts in coffee P/reference medians
Further research
Check the table of 6 conditions, prespecified contrasts and original other_conditions records to attribute each result individually to the corresponding composition/time.
Remaining uncertainty
Composition/contrasts for the 6 conditions, original tables of secondary results and locations of conflicts. This limitation applies only to the current input and the scope of verification at that time; it does not mean absence of new studies, an effect of 0, safety certification or failed external access this time.
Conditions for verification
Separate the two selected conditions from other contrasts, leaving unavailable secondary results within the bibliographic/reference scope.
Why this condition is needed
Needed to avoid merging every contrast in the same trial into an identical effect or independent replication of adding AA 80 mg in the fasted state.
Application exceptions
The current input only references other_conditions.json; it was not opened. No secondary-condition numbers or counterpart values for conflicts are filled in.
Referenced methods
C05: M03 §3.2.2–3.2.3; reverse-direction labeling and adaptation for testing are internally designed / C06: M03 §3.2.4, M15 §15.3.1–15.3.3; outcome adaptation for each question is internally designed / C08: M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses is internally designed / E07: M04 §4.6.1–4.6.2, M15 §15.3.1; internal application. The rationale for application to this case is to avoid merging every contrast in the same trial into an identical effect or independent replication of adding AA 80 mg in the fasted state. This does not constitute new reading of full methods texts, formal application of RoB 2/GRADE/causal tools or certification of minimum clinical criteria.

Related sources S01

N30 · What roles do the long-term balance, dietary and nonsimultaneous-administration studies in S05–S08 play?

Current findings
S05–S08 concern apparent absorption with low iron stores, ongoing absorption/status, total-diet nonheme iron, and iron status/tea/AA in young Indian women. The original counterview records that null long-term balance findings, nonsimultaneous administration and whole-diet changes differ from this main comparison. The current bibliographic entries do not contain actual numerical results for each study.
Verification status
Partly verified
Materials actually read
Summary read: the actual locations and values in the designated source's stored summary were read. Access to the external material types was not attempted this time; they were neither acquired nor read.
Why unverified
The related questions and the historical boundaries on treating them as refutation have been read. Detailed exposure, denominators and results for each trial cannot be directly cross-checked from the current input alone.
Reason for missing information
Individual methods, diet/exposure, endpoints, denominators and original results for S05–S08
Required materials and conditions
Each study's actual population, diet/simultaneous exposure, absorption/balance endpoint, timing and original results/denominators
Materials to obtain first
Each study's actual population, diet/simultaneous exposure, absorption/balance endpoint, timing and original results/denominators
Further research
Cross-check each article's methods/original results separately to verify differences in simultaneous exposure, dietary changes, balance and isotope endpoints.
Remaining uncertainty
Individual methods, diet/exposure, endpoints, denominators and original results for S05–S08. This limitation applies only to the current input and the scope of verification at that time; it does not mean absence of new studies, an effect of 0, safety certification or failed external access this time.
Conditions for verification
Retain S05–S08 as related material, while explaining how their conditions/measures differ from the same fasted-capsule comparison with simultaneous 80 mg administration.
Why this condition is needed
Needed to avoid merging null findings from other dietary/long-term balance studies into direct refutation of the main comparison, or counting them as direct replications from titles alone.
Application exceptions
Do not reconstruct unprovided numbers, effects or durations from bibliographic entries that only reference sources.json.
Referenced methods
E07: M04 §4.6.1–4.6.2, M15 §15.3.1; internal application / C05: M03 §3.2.2–3.2.3; reverse-direction labeling and adaptation for testing are internally designed / C06: M03 §3.2.4, M15 §15.3.1–15.3.3; outcome adaptation for each question is internally designed / C08: M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses is internally designed. The rationale for application to this case is to avoid merging null findings from other dietary/long-term balance studies into direct refutation of the main comparison, or counting them as direct replications from titles alone. This does not constitute new reading of full methods texts, formal application of RoB 2/GRADE/causal tools or certification of minimum clinical criteria.

Related sources S05 S06 S07 S08

N31 · Can S09–S12 and S21 be combined as effects for the same main comparison?

Current findings
S09 concerns overweight/obese women; S10 concerns ferrous fumarate, AA and Na2EDTA; S11's title concerns fortified foods, millet porridge and phytase/AA. S12 is a hematological comparison of daily/alternate-day iron, not single-ingredient AA addition. S21 provides a lead concerning inflammation, hepcidin and absorption in overweight women. No numerical results beyond the bibliographic verification level are added.
Verification status
Partly verified
Materials actually read
Summary read: the actual locations and values in the designated source's stored summary were read. Access to the external material types was not attempted this time; they were neither acquired nor read.
Why unverified
The roles of different questions in the titles and retained locations have been distinguished. Detailed original results/denominators and actual family identities are not provided in the current summary.
Reason for missing information
Populations/compositions, measures, denominators/results and unique families for S09–S12 and S21
Required materials and conditions
Actual ingredients/populations/measures and results in studies of overweight/obesity or inflammation, food fortification/phytase/Na2EDTA, and iron dosing schedules
Materials to obtain first
Actual ingredients/populations/measures and results in studies of overweight/obesity or inflammation, food fortification/phytase/Na2EDTA, and iron dosing schedules
Further research
Verify the actual populations, exposure/concomitant treatments, endpoints and study families of related studies individually to assess their directness for this question.
Remaining uncertainty
Populations/compositions, measures, denominators/results and unique families for S09–S12 and S21. This limitation applies only to the current input and the scope of verification at that time; it does not mean absence of new studies, an effect of 0, safety certification or failed external access this time.
Conditions for verification
Identify each bibliographic entry's different population/intervention/endpoint, without automatically adding it to the count of directly eligible families.
Why this condition is needed
Needed to avoid turning results from other populations, combined compositions, iron schedules or hematological outcomes into direct absorption replications of single-ingredient AA addition.
Application exceptions
Do not claim verification of a full text or direct result solely from S11's title and methods citation or S12's publication timing.
Referenced methods
C04: M03 §3.2.1; detailed population criteria are internally designed / C05: M03 §3.2.2–3.2.3; reverse-direction labeling and adaptation for testing are internally designed / C06: M03 §3.2.4, M15 §15.3.1–15.3.3; outcome adaptation for each question is internally designed / E07: M04 §4.6.1–4.6.2, M15 §15.3.1; internal application. The rationale for application to this case is to avoid turning results from other populations, combined compositions, iron schedules or hematological outcomes into direct absorption replications of single-ingredient AA addition. This does not constitute new reading of full methods texts, formal application of RoB 2/GRADE/causal tools or certification of minimum clinical criteria.

Related sources S09 S10 S11 S12 S21

N32 · Has discovery of registrations/reviews in S18–S20 been treated as verification of results?

Current findings
S18 is the indexed Study Plan for a registration concerning insect-derived dietary iron and chitin/AA. S19 is an indexed title of a fruit/juice review, with its full text recorded as not acquired. S20 is a title lead for FeHydroA; its exact registration URL remains unresolved. These are not counted as independent results for the current main comparison.
Verification status
Unverified
Materials actually read
Summary read: the actual locations and values in the designated source's stored summary were read. Access to the external material types was not attempted this time; they were neither acquired nor read.
Why unverified
Plan/discovery identities are present, but no material is available to verify direct results, the review's included trials or the exact original S20 record.
Reason for missing information
Actual S18 results, S19's included-trial table, and the exact S20 registration and results
Required materials and conditions
Actual result status in the INSECTE registration, the included-trial table in the fruit/juice review, and the exact FeHydroA registration URL and original results
Materials to obtain first
Actual result status in the INSECTE registration, the included-trial table in the fruit/juice review, and the exact FeHydroA registration URL and original results
Further research
Cross-check posted registration results, review tables of included trials and exact records to distinguish unique trials/reports from information that remains a plan.
Remaining uncertainty
Actual S18 results, S19's included-trial table, and the exact S20 registration and results. This limitation applies only to the current input and the scope of verification at that time; it does not mean absence of new studies, an effect of 0, safety certification or failed external access this time.
Conditions for verification
Retain the level of plan/index/review discovery, distinguishing the absence of results, included-trial information or a confirmed URL.
Why this condition is needed
Needed to avoid promoting registered plans, review discovery or unresolved search leads to independent positive/no-difference absorption trials.
Application exceptions
When an exact URL is unverified, do not attach a portal homepage as though it were the link to the specific original record.
Referenced methods
C02: Distinction between studies and reports in M04 §4.6.1–4.6.2; cohort/outcome linkage is an internal application / C03: Principles for data collection/selection in M04 §4.5–4.6; separation of access from reading and the hyperlink contract are internally designed / C09: M04 §4.5, §4.6.3; limits on the current data transformation follow the user-defined scope and internal design / E06: M08 Table 8.2.a, M04 §4.6.3; internal application / E07: M04 §4.6.1–4.6.2, M15 §15.3.1; internal application. The rationale for application to this case is to avoid promoting registered plans, review discovery or unresolved search leads to independent positive/no-difference absorption trials. This does not constitute new reading of full methods texts, formal application of RoB 2/GRADE/causal tools or certification of minimum clinical criteria.

Related sources S18 S19 S20

N33 · What is the verification scope for ETH funding, product supply and conflicts of interest?

Current findings
The retained record describes funding from the ETH Zurich Laboratory of Human Nutrition and a declaration of no competing financial interests. The Ferrum Hausmann/Vifor and Sigma Aldrich product names are not evidence of donated products or manufacturer funding. Product supply remains not reported.
Verification status
Partly verified
Materials actually read
Summary read: the actual locations and values in the designated source's stored summary were read. Access to the external material types was not attempted this time; they were neither acquired nor read.
Why unverified
The funding and declaration level are documented, but product supply and the full set of relationships cannot be established. The existing I2 is not reused as a new criterion assessment.
Reason for missing information
Detailed records of product supply/support and institutional/author relationships
Required materials and conditions
Actual records of ETH Zurich Laboratory of Human Nutrition funding, declarations of competing financial interests, product supply and institutional/author relationships
Materials to obtain first
Actual records of ETH Zurich Laboratory of Human Nutrition funding, declarations of competing financial interests, product supply and institutional/author relationships
Further research
Cross-check funding/acknowledgments/COI and product-supply records to examine the level of disclosure and scope of funding/institutional independence.
Remaining uncertainty
Detailed records of product supply/support and institutional/author relationships. This limitation applies only to the current input and the scope of verification at that time; it does not mean absence of new studies, an effect of 0, safety certification or failed external access this time.
Conditions for verification
Distinguish reported funding/declarations from unreported product supply, retaining relationships that remain unverified.
Why this condition is needed
Needed to avoid treating academic funding/a declaration of no competing interests as proof of complete independence or absence of bias, or inferring sponsorship from a brand name.
Application exceptions
The existing I2 axis is preserved as a historical value, without being used as a new independence grade or certification of replication across families.
Referenced methods
C10: Chamgap's own independence/attribution criteria. The formal methods sections used in this pilot do not endorse every detail of this item / C02: Distinction between studies and reports in M04 §4.6.1–4.6.2; cohort/outcome linkage is an internal application. The rationale for application to this case is to avoid treating academic funding/a declaration of no competing interests as proof of complete independence or absence of bias, or inferring sponsorship from a brand name. This does not constitute new reading of full methods texts, formal application of RoB 2/GRADE/causal tools or certification of minimum clinical criteria.

Related sources S01

N34 · Can adverse reactions and withdrawal frequencies under the same conditions be verified?

Current findings
Condition-specific adverse-reaction counts are recorded as not reported in the stored summary. Of 35 participants, 1 withdrew after the first visit because of difficulty maintaining the fast, but the condition is unverified. This is not recast as 0 AEs or an AA-related withdrawal.
Verification status
Unverified
Materials actually read
Summary read: the actual locations and values in the designated source's stored summary were read. Access to the external material types was not attempted this time; they were neither acquired nor read.
Why unverified
Without condition-specific events, exposure denominators/periods and collection definitions, comparative harms, incidence and causality cannot be established.
Reason for missing information
Condition-specific AE collection/events, exposure/periods and the condition of withdrawal
Required materials and conditions
Condition-specific AE definitions, collection methods, numbers of exposed people/people with events, event counts and periods, and the condition/causal attribution of the fasting-related withdrawal
Materials to obtain first
Condition-specific AE definitions, collection methods, numbers of exposed people/people with events, event counts and periods, and the condition/causal attribution of the fasting-related withdrawal
Further research
Cross-check the AE collection plan, condition-specific event/exposure/withdrawal tables and follow-up records to verify event frequency and the scope of signal interpretation.
Remaining uncertainty
Condition-specific AE collection/events, exposure/periods and the condition of withdrawal. This limitation applies only to the current input and the scope of verification at that time; it does not mean absence of new studies, an effect of 0, safety certification or failed external access this time.
Conditions for verification
Separate the record of AEs not reported from the withdrawal reason/unverified condition, without newly calculating incidence or establishing causality.
Why this condition is needed
Needed to avoid turning positive absorption findings or unreported condition-specific AEs into absence of adverse effects or proof of safety.
Application exceptions
Do not arbitrarily classify the 1 withdrawal due to difficulty maintaining the fast as vitamin C harm or as 0 events.
Referenced methods
E10: M19 §19.1.2–19.2.4; internal application / H01: M19 §19.1.2–19.2.4; detailed distinctions are internally designed / H02: Design-specific harms questions in M19 §19.2; temporal-relationship details are internally designed / H03: M19 §19.2.2–19.2.4, M03 §3.2.3; internal application / H04: M19 §19.1.2–19.2.4; internal application / H06: M19 §19.1.2–19.2.4, M04 §4.6.3; internal application / H09: Chamgap's own interpretive boundaries. These reference M19 principles and do not constitute formal application of a causality tool. The rationale for application to this case is to avoid turning positive absorption findings or unreported condition-specific AEs into absence of adverse effects or proof of safety. This does not constitute new reading of full methods texts, formal application of RoB 2/GRADE/causal tools or certification of minimum clinical criteria.

Related sources S01

N35 · Which safety questions do the NIH, NIDDK and NCI materials address?

Current findings
The retained general safety background includes a total-intake upper limit of 2,000 mg/day for adults aged 19 years and older, caution concerning iron overload and G6PD in the high-dose intravenous context. S13–S15 are official explanatory sources; they are not condition-specific event counts for oral 80 mg or individual intake recommendations.
Verification status
Met
Materials actually read
Summary read: the actual locations and values in the designated source's stored summary were read. Access to the external material types was not attempted this time; they were neither acquired nor read.
Why unverified
The interpretive routes and age/exposure boundaries for each background source have been distinguished. This does not mean that external original texts or individual safety have been verified in the current work.
Reason for missing information
Direct harms data for this oral condition and evidence for vulnerable groups/long-term exposure are unverified.
Required materials and conditions
Scope of the UL of 2,000 mg/day for adults aged 19 years and older, caution concerning iron overload, the high-dose intravenous/G6PD context and the actual route/dose
Materials to obtain first
Scope of the UL of 2,000 mg/day for adults aged 19 years and older, caution concerning iron overload, the high-dose intravenous/G6PD context and the actual route/dose
Further research
Compare the populations/routes/doses in official safety materials with the trial, examining direct harms comparisons separately from general cautions.
Remaining uncertainty
Direct harms data for this oral condition and evidence for vulnerable groups/long-term exposure are unverified. This limitation applies only to the current input and the scope of verification at that time; it does not mean absence of new studies, an effect of 0, safety certification or failed external access this time.
Conditions for verification
Separate the actual population, route/dose and general background role of each official source.
Why this condition is needed
Needed to avoid promoting official general safety background to individual safety or event incidence in this 80 mg oral trial.
Application exceptions
The UL is neither an individual's recommended intake nor a guarantee of unrestricted safety, and the same adult threshold is not extended to age 18.
Referenced methods
E10: M19 §19.1.2–19.2.4; internal application / H05: Design considerations in M19 §19.2.2–19.2.4; detailed confounding records are internally designed / H08: M19 §19.1.2–19.2.4; internal application / H09: Chamgap's own interpretive boundaries. These reference M19 principles and do not constitute formal application of a causality tool / C04: M03 §3.2.1; detailed population criteria are internally designed / C05: M03 §3.2.2–3.2.3; reverse-direction labeling and adaptation for testing are internally designed. The rationale for application to this case is to avoid promoting official general safety background to individual safety or event incidence in this 80 mg oral trial. This does not constitute new reading of full methods texts, formal application of RoB 2/GRADE/causal tools or certification of minimum clinical criteria.

Related sources S13 S14 S15

N36 · Can the same effect be applied to other populations, durations and health endpoints?

Current findings
Do not generalize directly to men, older people, people with normal iron stores, anemia, pregnancy/lactation, children, renal disease, iron overload or inflammatory disease. The direction of acute FIA is not a result for long-term maintenance, anemia treatment, fatigue/vitality or overall safety.
Verification status
Not applicable
Materials actually read
Summary read: the actual locations and values in the designated source's stored summary were read. Access to the external material types was not attempted this time; they were neither acquired nor read.
Why unverified
Confirmation of extended effects does not apply to this table's narrow question. No judgment has been made that evidence for each extension is absent or that the effect is null.
Reason for missing information
Direct verification in other populations, of long-term maintenance or of clinical health outcomes is a separate question.
Required materials and conditions
Direct data for men, older people, normal iron stores, anemia, pregnancy/lactation, children, renal disease/inflammation/iron overload and long-term/health endpoints
Materials to obtain first
Direct data for men, older people, normal iron stores, anemia, pregnancy/lactation, children, renal disease/inflammation/iron overload and long-term/health endpoints
Further research
Examine direct comparisons and prespecified subgroups/interactions separately by population, exposure, duration and endpoint, designing necessary extension questions separately.
Remaining uncertainty
Direct verification in other populations, of long-term maintenance or of clinical health outcomes is a separate question. This limitation applies only to the current input and the scope of verification at that time; it does not mean absence of new studies, an effect of 0, safety certification or failed external access this time.
Conditions for verification
Distinguish the original population/single-exposure FIA from unverified direct evidence for excluded populations and long-term/clinical endpoints.
Why this condition is needed
Needed to avoid extending an acute surrogate in a limited population of young nonanemic women to health benefit or safety for everyone.
Application exceptions
Trials for each extension question are not required to complete the narrow main comparison, and these questions are not converted into a general absence of evidence or an effect of 0.
Referenced methods
C04: M03 §3.2.1; detailed population criteria are internally designed / E08: M03 §3.2.1–3.2.4; details of dose, duration and effect modification are internally designed / E09: M03 §3.2.4; internally defined limits on extrapolation / H08: M19 §19.1.2–19.2.4; internal application. The rationale for application to this case is to avoid extending an acute surrogate in a limited population of young nonanemic women to health benefit or safety for everyone. This does not constitute new reading of full methods texts, formal application of RoB 2/GRADE/causal tools or certification of minimum clinical criteria.

Related sources S01 P907

N37 · Have the original C/50, Caution and axes been kept from being reused as new criterion statuses?

Current findings
Preserve the original C/50, Caution, the B·S·R1·I2·EX·CX·B2 axes and document quality as historical values. The existing scoring explanation involving n<200/completer analysis is not a minimum-participant criterion for the new table. No new calculation, grade or fulfillment rate was created.
Verification status
Met
Materials actually read
Summary read: the actual locations and values in the designated source's stored summary were read. Access to the external material types was not attempted this time; they were neither acquired nor read.
Why unverified
The roles of existing values and new record statuses have been separated. Met in the table does not signify the original efficacy grade, confirmation of safety or a probability.
Reason for missing information
Reassessment of the existing judgment and new scoring are outside the work performed in this scope.
Required materials and conditions
Separation of historical values for the original grade, score, safety, axes, document quality and assessment calculations from the new row statuses
Materials to obtain first
Separation of historical values for the original grade, score, safety, axes, document quality and assessment calculations from the new row statuses
Further research
Compare hashes/values between the original input and the produced version to check preservation of the assessment, axes and calculations, and audit the meaning of criterion statuses separately.
Remaining uncertainty
Reassessment of the existing judgment and new scoring are outside the work performed in this scope. This limitation applies only to the current input and the scope of verification at that time; it does not mean absence of new studies, an effect of 0, safety certification or failed external access this time.
Conditions for verification
Preserve the original assessment, axes and historical calculations unchanged, and let new criterion statuses represent only individual record/gap review.
Why this condition is needed
Needed to avoid arbitrarily introducing n<200 or other existing scoring rules as new sufficiency criteria, or converting them into a criterion-fulfillment rate or clinical certification.
Application exceptions
The original grade and numbers are neither deleted nor regraded. document_quality A and efficacy C are different original fields.
Referenced methods
C09: M04 §4.5, §4.6.3; limits on the current data transformation follow the user-defined scope and internal design / E05: M15 §15.3.1–15.3.3; internal application / H09: Chamgap's own interpretive boundaries. These reference M19 principles and do not constitute formal application of a causality tool. The rationale for application to this case is to avoid arbitrarily introducing n<200 or other existing scoring rules as new sufficiency criteria, or converting them into a criterion-fulfillment rate or clinical certification. This does not constitute new reading of full methods texts, formal application of RoB 2/GRADE/causal tools or certification of minimum clinical criteria.

Related sources S01

N38 · Have this table's input, criterion freeze, application and verification scope been recorded?

Current findings
The evidence cutoff is 2026-09-16; records of 59 general web searches and 1 failed PubMed-specific search at that time are preserved. The 2026-10-05 review described here read the designated stored summary and family definitions, recording actual copies/hashes and individual criterion freezes/applications. External searches, full-text reading, API access, clinical calculations/reassessment and deployment are not performed.
Verification status
Met
Materials actually read
Summary read: the actual locations and values in the designated source's stored summary were read. Access to the external material types was not attempted this time; they were neither acquired nor read.
Why unverified
The actual retained input/version, times and current work scope have been recorded. This is not official preregistration, independent clinical certification or an up-to-date verification of the entire literature.
Reason for missing information
New cross-checks of external full texts/searches, content QA by another author, derived tables, UI, and shared registration/deployment are separate stages.
Required materials and conditions
The 2026-09-16 evidence cutoff and search scope at that time; the actual 2026-10-05 review, original bytes/SHA, and records of criteria frozen before application
Materials to obtain first
The 2026-09-16 evidence cutoff and search scope at that time; the actual 2026-10-05 review, original bytes/SHA, and records of criteria frozen before application
Further research
Audit original bytes, pointers, versions/event times and row-level model records, updating new-material/criterion-revision events separately.
Remaining uncertainty
New cross-checks of external full texts/searches, content QA by another author, derived tables, UI, and shared registration/deployment are separate stages. This limitation applies only to the current input and the scope of verification at that time; it does not mean absence of new studies, an effect of 0, safety certification or failed external access this time.
Conditions for verification
Link criterion versions/hashes with actual freeze→record→application→writing times, explicitly stating the scope and absence of new work.
Why this condition is needed
Needed to avoid overstating transformation of the stored summary as an up-to-date comprehensive search, clinical preregistration, methodological certification or completed deployment.
Application exceptions
These are internally developed criteria for a development case already read. The 59 searches and 1 failure are historical records, not new searches in this work.
Referenced methods
C03: Principles for data collection/selection in M04 §4.5–4.6; separation of access from reading and the hyperlink contract are internally designed / C09: M04 §4.5, §4.6.3; limits on the current data transformation follow the user-defined scope and internal design / C01: Principles for clarifying the question in M03 §3.1, §3.2.1–3.2.4; detailed separation rules are internally designed. The rationale for application to this case is to avoid overstating transformation of the stored summary as an up-to-date comprehensive search, clinical preregistration, methodological certification or completed deployment. This does not constitute new reading of full methods texts, formal application of RoB 2/GRADE/causal tools or certification of minimum clinical criteria.

Related sources S01