# Ordinary thiamine (vitamin B1); actual salt not reported × Three-month Cockcroft–Gault-derived renal-function readout in early diabetic nephropathy Verdict 3121 · Evidence Check Stored-material review date: 2026-10-04 Original evidence date: 2026-09-16 Review-criteria version: 3121-ORAL-THIAMINE-CG-3M-1.0 Public page/material preparation date: 2026-11-07 Clinical papers were not read directly; existing review summaries were checked. No new clinical-literature search was performed. Unverified does not mean that research is absent or that there is no effect. ## Assessment scope - Population: Age 35–65 years, type 2 diabetes and persistent microalbuminuria; CKD stage and uniform deficiency status unverified - Ingredient, formulation and route: Thiamine as the single active ingredient in the trial; salt not reported; conflicting capsule/tablet descriptions - Dose: Nominal 3×100 mg/day; 300 mg/day; free-thiamine equivalent unverified - Comparator: Placebo + usual diabetes/blood-pressure treatment; imbalance in background treatment, including insulin, explicitly noted - Measured outcome: End mean of the value labeled GFR derived using Cockcroft–Gault at 3 months (mL/min); unadjusted descriptive between-group difference - Duration: Treatment duration and main time point: 3 months; the additional 2 months of observation after discontinuation are separate - Questions outside this scope: Urinary albumin, annual slope/long-term events, CKD overall, other derivatives/combinations/dialysis, and observational/acute/animal data are not combined as direct effects. ## Checklist items ### N01 · Which thiamine renal-function question is being presented in a single table? Verification status: Met Reading scope: Only the designated retained stored summaries were actually read. External full texts/abstracts/tables/registries and old separate files have not been read in the current work. - Current findings: The original claim concerns the renal-function readout derived using Cockcroft–Gault at 3 months in early diabetic nephropathy. There are currently no subclaims; the question concerns the end mean with oral ordinary thiamine as a single active ingredient versus placebo/usual care. It was not extended to CKD overall, annual slope or long-term progression. - Why unverified: The boundaries in the Korean body text, facets and primary_result agree. This does not mean that a causal effect or clinical benefit has been verified. - Reason for missing information: The boundaries in the Korean body text, facets and primary_result agree. This does not mean that a causal effect or clinical benefit has been verified. - Required materials and conditions: The current manuscript's boundaries for population, single active ingredient, oral route, placebo/usual care, and CG end mean at 3 months - Materials to obtain first: The current manuscript's boundaries for population, single active ingredient, oral route, placebo/usual care, and CG end mean at 3 months - Further research: Extract direct comparative results within this boundary, and keep eGFR slope and kidney-failure events as separate questions. - Conditions for verification: Retain the same independent question as the original /ko/effect and the actual PICO/time point, and explain the excluded questions. - Why this condition is needed: Required to avoid combining renal-function values, urinary albumin, long-term progression and other preparations into a single efficacy status. - Application exceptions: Do not remove the unspecified CKD stage and unreported salt to present an apparently precise identity. - Remaining uncertainty: The boundaries in the Korean body text, facets and primary_result agree. This does not mean that a causal effect or clinical benefit has been verified. - Referenced methods: Chamgap's own adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/missing data, precision and interpretation of harms. This is not formal implementation or certification of those methods. - Related sources: S01 ### N02 · Have the actual salt and equivalent amount of single-ingredient ordinary thiamine been verified? Verification status: Partly verified Reading scope: Only the designated retained stored summaries were actually read. External full texts/abstracts/tables/registries and old separate files have not been read in the current work. - Current findings: Ordinary thiamine is the trial's sole active ingredient, and the actual salt is not reported. Manufacturing origin, manufacturer, excipients and free-thiamine equivalent are also unverified. Do not identify the trial product from the authorized thiamine hydrochloride product in S13 or benfotiamine in S09. - Why unverified: The single-active-ingredient boundary is recorded, but the actual chemical form and product identity cannot be established from the retained materials. - Reason for missing information: The single-active-ingredient boundary is recorded, but the actual chemical form and product identity cannot be established from the retained materials. - Required materials and conditions: Trial product ingredient list, salt, purity, manufacturer, excipients and free-thiamine equivalent - Materials to obtain first: Trial product ingredient list, salt, purity, manufacturer, excipients and free-thiamine equivalent - Further research: Verify identity against the original product and manufacturing/ingredient records, and review other salts and derivatives separately. - Conditions for verification: Record the original trial's single active ingredient separately from the unverified chemical form/product identity. - Why this condition is needed: Required to avoid treating ordinary thiamine, hydrochloride, nitrate, benfotiamine and a separate authorized product as the same exposure. - Application exceptions: Preserve the record of a single active ingredient, but do not fill in hydrochloride for the unreported salt. - Remaining uncertainty: The single-active-ingredient boundary is recorded, but the actual chemical form and product identity cannot be established from the retained materials. - Referenced methods: Chamgap's own adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/missing data, precision and interpretation of harms. This is not formal implementation or certification of those methods. - Related sources: S01, S09, S13 ### N03 · Has the difference between the capsule and tablet descriptions in the original article been resolved? Verification status: Conflicting information Reading scope: Only the designated retained stored summaries were actually read. External full texts/abstracts/tables/registries and old separate files have not been read in the current work. - Current findings: The current Korean record describes capsules in the S01 abstract and tablets in the methods, leaving the actual physical dosage form in conflict. The boundary of ordinary thiamine as a single active ingredient is separate from this unresolved wording. - Why unverified: Evidence about the actual product that would resolve the capsule/tablet discrepancy in the same trial has not yet been linked. - Reason for missing information: Evidence about the actual product that would resolve the capsule/tablet discrepancy in the same trial has not yet been linked. - Required materials and conditions: Exact dosage-form wording in the S01 abstract and methods, and product/batch verification materials - Materials to obtain first: Exact dosage-form wording in the S01 abstract and methods, and product/batch verification materials - Further research: Compare the original article's dosage-form descriptions with product records to clarify the physical dosage form in the same trial. - Conditions for verification: Preserve both descriptions and retain the conflict until verified against evidence about the actual product. - Why this condition is needed: Required to avoid silently harmonizing different dosage-form descriptions within the same original article. - Application exceptions: Do not infer a different trial or a difference in effects from the capsule/tablet discrepancy. - Remaining uncertainty: Evidence about the actual product that would resolve the capsule/tablet discrepancy in the same trial has not yet been linked. - Referenced methods: Chamgap's own adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/missing data, precision and interpretation of harms. This is not formal implementation or certification of those methods. - Related sources: S01 ### N04 · Have the nominal dose and the actual dosing schedule and adherence been distinguished? Verification status: Partly verified Reading scope: Only the designated retained stored summaries were actually read. External full texts/abstracts/tables/registries and old separate files have not been read in the current work. - Current findings: In S01, the nominal 3×100 mg/day and total 300 mg/day are previously verified values. However, a divided schedule of 3 times a day, meal timing, the actual adherence rate and free-thiamine equivalent remain unverified. Do not turn the nominal amount into an individual dosing recommendation. - Why unverified: The nominal amount is recorded, but materials needed to establish actual exposure, schedule and adherence remain outstanding. - Reason for missing information: The nominal amount is recorded, but materials needed to establish actual exposure, schedule and adherence remain outstanding. - Required materials and conditions: Nominal 3×100 mg/day; actual administration/intake records; meal timing; adherence rate; active-ingredient equivalent - Materials to obtain first: Nominal 3×100 mg/day; actual administration/intake records; meal timing; adherence rate; active-ingredient equivalent - Further research: Link the original intake and adherence records to product identity to extract actual exposure. - Conditions for verification: Preserve the original nominal amount, and indicate gaps in the actual divided-dose schedule, meals, adherence and equivalence conversion. - Why this condition is needed: Required to avoid automatically converting a nominal total amount into actual exposure or a schedule of 3 times a day. - Application exceptions: The retained 300 mg/day is an existing record, not a value calculated in the current work or a suggested dose for self-administration. - Remaining uncertainty: The nominal amount is recorded, but materials needed to establish actual exposure, schedule and adherence remain outstanding. - Referenced methods: Chamgap's own adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/missing data, precision and interpretation of harms. This is not formal implementation or certification of those methods. - Related sources: S01 ### N05 · Have 3 months of treatment and 2 months of observation after discontinuation been separated? Verification status: Partly verified Reading scope: Only the designated retained stored summaries were actually read. External full texts/abstracts/tables/registries and old separate files have not been read in the current work. - Current findings: The selected main time point and treatment duration are 3 months. The 2 months of observation after discontinuation in the existing manuscript are separate; they are not combined with the end mean at 3 months and called 5 months of treatment or a sustained effect. - Why unverified: The distinction between periods has been verified, but specific results addressing maintenance of renal function after discontinuation are separate from the current target result. - Reason for missing information: The distinction between periods has been verified, but specific results addressing maintenance of renal function after discontinuation are separate from the current target result. - Required materials and conditions: Results at the main time point of 3 months; treatment duration; original endpoint-specific results during the additional 2 months of observation after discontinuation - Materials to obtain first: Results at the main time point of 3 months; treatment duration; original endpoint-specific results during the additional 2 months of observation after discontinuation - Further research: Extract actual renal-function results at each visit and post-discontinuation time point separately to retain the time boundaries. - Conditions for verification: Record the main time point/treatment and additional observation after discontinuation separately, and retain the scope for which direct results on maintenance are unavailable. - Why this condition is needed: Required to avoid turning end-of-treatment results into a sustained effect over 5 months or an annual slope. - Application exceptions: Do not establish a sustained effect solely from the existence of additional observation. - Remaining uncertainty: The distinction between periods has been verified, but specific results addressing maintenance of renal function after discontinuation are separate from the current target result. - Referenced methods: Chamgap's own adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/missing data, precision and interpretation of harms. This is not formal implementation or certification of those methods. - Related sources: S01 ### N06 · Have the actual participants' diabetes, microalbuminuria and CKD stage been verified? Verification status: Partly verified Reading scope: Only the designated retained stored summaries were actually read. External full texts/abstracts/tables/registries and old separate files have not been read in the current work. - Current findings: S01 is a pilot trial in adults aged 35–65 years with type 2 diabetes and persistent microalbuminuria, with 40 participants. CKD stage is unspecified, and this is not the same population as dialysis, transplant or nondiabetic CKD populations. - Why unverified: Age, disease and albuminuria are recorded, but stage and applicability to all CKD cannot be established. - Reason for missing information: Age, disease and albuminuria are recorded, but stage and applicability to all CKD cannot be established. - Required materials and conditions: Eligibility criteria for age 35–65 years, type 2 diabetes and persistent microalbuminuria; baseline renal function; CKD stage - Materials to obtain first: Eligibility criteria for age 35–65 years, type 2 diabetes and persistent microalbuminuria; baseline renal function; CKD stage - Further research: Compare original eligibility criteria, baseline distributions and stage data, and review direct comparisons by stage/cause separately. - Conditions for verification: Retain the verified age/disease/albuminuria together with the unverified stage, and indicate population differences. - Why this condition is needed: Required to avoid extending early diabetic nephropathy to CKD of all causes/stages or to dialysis/transplantation. - Application exceptions: Do not replace the currently unspecified CKD stage with an arbitrary stage 1/2/3. - Remaining uncertainty: Age, disease and albuminuria are recorded, but stage and applicability to all CKD cannot be established. - Referenced methods: Chamgap's own adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/missing data, precision and interpretation of harms. This is not formal implementation or certification of those methods. - Related sources: S01 ### N07 · Can correction of deficiency be distinguished from additional supplementation in nondeficient participants? Verification status: Partly verified Reading scope: Only the designated retained stored summaries were actually read. External full texts/abstracts/tables/registries and old separate files have not been read in the current work. - Current findings: The retained manuscript contains both low plasma thiamine and indicators of adequate dietary intake. It did not classify everyone as deficient or replete. For the analysis exclusion of 1 participant with very high baseline thiamine and possible prior supplementation, the arm and the extent of applicability to GFR remain unverified. - Why unverified: Materials needed to distinguish uniform deficiency status in the population and the effects of deficiency correction versus additional supplementation in nondeficient participants remain outstanding. - Reason for missing information: Materials needed to distinguish uniform deficiency status in the population and the effects of deficiency correction versus additional supplementation in nondeficient participants remain outstanding. - Required materials and conditions: Baseline plasma/dietary thiamine status; definition of deficiency; eligibility/analysis exclusions; renal-function results by status - Materials to obtain first: Baseline plasma/dietary thiamine status; definition of deficiency; eligibility/analysis exclusions; renal-function results by status - Further research: Link nutritional-status definitions and analyses by status to actual renal-function denominators. - Conditions for verification: Distinguish verified status indicators from unverified uniform deficiency and separately attributable effects. - Why this condition is needed: Required to avoid harmonizing low plasma levels and indicators of dietary adequacy into a single deficient/nondeficient population. - Application exceptions: Do not confuse the analysis exclusion of 1 participant with high thiamine levels with uniform deficiency status across the whole population. - Remaining uncertainty: Materials needed to distinguish uniform deficiency status in the population and the effects of deficiency correction versus additional supplementation in nondeficient participants remain outstanding. - Referenced methods: Chamgap's own adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/missing data, precision and interpretation of harms. This is not formal implementation or certification of those methods. - Related sources: S01 ### N08 · Has the actual balance of placebo and usual treatment been verified? Verification status: Partly verified Reading scope: Only the designated retained stored summaries were actually read. External full texts/abstracts/tables/registries and old separate files have not been read in the current work. - Current findings: The comparator is placebo with usual diabetes/blood-pressure treatment. The current manuscript explicitly notes imbalances in background treatment, including insulin. Changes and rescue treatment by arm, and the adjusted contribution of thiamine, have not been established. - Why unverified: The direction of comparison and concomitant-treatment imbalance are recorded, but adjustment/change data separating the causal contribution are insufficient. - Reason for missing information: The direction of comparison and concomitant-treatment imbalance are recorded, but adjustment/change data separating the causal contribution are insufficient. - Required materials and conditions: Placebo identity; diabetes/blood-pressure treatment by arm; insulin; changes/rescue treatment; analytical adjustment - Materials to obtain first: Placebo identity; diabetes/blood-pressure treatment by arm; insulin; changes/rescue treatment; analytical adjustment - Further research: Compare baseline/follow-up differences in concomitant treatment and their impact on analysis against the original materials. - Conditions for verification: Distinguish placebo/usual care from actual imbalances and unverified changes/adjustments. - Why this condition is needed: Required to avoid attributing differences in background treatment to thiamine's contribution. - Application exceptions: Compare the actual effect of interest and analysis without requiring every change in both arms to be identical. - Remaining uncertainty: The direction of comparison and concomitant-treatment imbalance are recorded, but adjustment/change data separating the causal contribution are insufficient. - Referenced methods: Chamgap's own adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/missing data, precision and interpretation of harms. This is not formal implementation or certification of those methods. - Related sources: S01, S03 ### N09 · At what level were randomization and concealment procedures reported? Verification status: Partly verified Reading scope: Only the designated retained stored summaries were actually read. External full texts/abstracts/tables/registries and old separate files have not been read in the current work. - Current findings: S01 reports a random-number table, central allocation and numbered opaque envelopes. The retained assessment also distinguishes this from an independent audit of concealment implementation. Do not describe the 40-person pilot trial as certified as a formal confirmatory trial. - Why unverified: The reporting of procedures has been verified, but independent verification of actual implementation and the adequacy of baseline data/analysis are separate matters. - Reason for missing information: The reporting of procedures has been verified, but independent verification of actual implementation and the adequacy of baseline data/analysis are separate matters. - Required materials and conditions: Actual procedures for the random-number table, central allocation and opaque envelopes; baseline balance; implementation records - Materials to obtain first: Actual procedures for the random-number table, central allocation and opaque envelopes; baseline balance; implementation records - Further research: Compare allocation, concealment and baseline-characteristic data for the outcome of interest. - Conditions for verification: Link the level of allocation/concealment recorded in the original source to unverified implementation and baseline limitations. - Why this condition is needed: Required to avoid claiming that allocation/concealment has been verified solely from the randomized-trial label. - Application exceptions: Distinguish reported procedures from an independent audit of implementation, and do not call the pilot trial a formal confirmatory trial. - Remaining uncertainty: The reporting of procedures has been verified, but independent verification of actual implementation and the adequacy of baseline data/analysis are separate matters. - Referenced methods: Chamgap's own adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/missing data, precision and interpretation of harms. This is not formal implementation or certification of those methods. - Related sources: S01 ### N10 · Have reported blinding and actual adherence/blinding success been distinguished? Verification status: Partly verified Reading scope: Only the designated retained stored summaries were actually read. External full texts/abstracts/tables/registries and old separate files have not been read in the current work. - Current findings: Blinding of participants, care providers and assessors is reported, but the actual adherence rate and blinding success remain unverified. Do not erase this limitation solely because the creatinine-derived measure is objective. - Why unverified: Reported blinding and actual success/adherence have different levels of verification. - Reason for missing information: Reported blinding and actual success/adherence have different levels of verification. - Required materials and conditions: Blinding of participants, care providers and assessors; actual adherence rate; blinding success; deviations by arm - Materials to obtain first: Blinding of participants, care providers and assessors; actual adherence rate; blinding success; deviations by arm - Further research: Link data on actual blinding, adherence and changes by arm to the original analysis. - Conditions for verification: Record whose blinding was reported separately from gaps concerning success/adherence. - Why this condition is needed: Required to avoid turning the double-blind label into actual balance of exposure or absence of bias. - Application exceptions: Do not remove post-allocation deviations or changes in measurement/treatment on the grounds that the formula-derived value is objective. - Remaining uncertainty: Reported blinding and actual success/adherence have different levels of verification. - Referenced methods: Chamgap's own adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/missing data, precision and interpretation of harms. This is not formal implementation or certification of those methods. - Related sources: S01 ### N11 · Have the formula, units and measurement boundaries of the value labeled GFR been verified? Verification status: Partly verified Reading scope: Only the designated retained stored summaries were actually read. External full texts/abstracts/tables/registries and old separate files have not been read in the current work. - Current findings: The original article calls it GFR, but the selected value is the end mean derived using Cockcroft–Gault at 3 months, in mL/min. The table notes recorded at the time mention Cockcroft–Gault/Jaffé; the value was not recast as body-surface-area-adjusted eGFR or measured GFR. The current work checked the retained location and did not newly audit the original measurement procedures. - Why unverified: The measure/unit boundaries are recorded, but the original measurement and arm-specific procedures were not directly verified in the current work. - Reason for missing information: The measure/unit boundaries are recorded, but the original measurement and arm-specific procedures were not directly verified in the current work. - Required materials and conditions: Original table notes on Cockcroft–Gault and creatinine/Jaffé; units; body-surface-area adjustment; measurement/assessment procedures - Materials to obtain first: Original table notes on Cockcroft–Gault and creatinine/Jaffé; units; body-surface-area adjustment; measurement/assessment procedures - Further research: Check the table notes and original measurement/calculation procedures to extract results by the same measure and units. - Conditions for verification: Distinguish the formula, units and labeling from unverified measurement procedures/errors. - Why this condition is needed: Required to avoid turning a formula-derived value into measured GFR, body-surface-area-adjusted eGFR or an annual slope. - Application exceptions: What was read in the current work was the retained extraction and the location of the notes, not a new audit of measurement in the original PDF. - Remaining uncertainty: The measure/unit boundaries are recorded, but the original measurement and arm-specific procedures were not directly verified in the current work. - Referenced methods: Chamgap's own adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/missing data, precision and interpretation of harms. This is not formal implementation or certification of those methods. - Related sources: S01 ### N12 · Have the page's target and the original trial's primary endpoint been distinguished? Verification status: Met Reading scope: Only the designated retained stored summaries were actually read. External full texts/abstracts/tables/registries and old separate files have not been read in the current work. - Current findings: GFR is this page's target, and the original trial's primary endpoint is urinary albumin. The retained primary_result also explicitly states that the page's target differs from the trial's primary endpoint. Do not transfer a reduction in urinary albumin to inhibition of renal-function deterioration. - Why unverified: The distinction between the roles of the two endpoints agrees with the retained manuscript. Comparison of the prespecified hierarchy with the original registry/plan separately remains unverified. - Reason for missing information: The distinction between the roles of the two endpoints agrees with the retained manuscript. Comparison of the prespecified hierarchy with the original registry/plan separately remains unverified. - Required materials and conditions: The original trial's urinary-albumin primary endpoint; role of the GFR result; endpoint hierarchy in the registry/plan - Materials to obtain first: The original trial's urinary-albumin primary endpoint; role of the GFR result; endpoint hierarchy in the registry/plan - Further research: Compare the registry and plan with the reported endpoint hierarchy, keeping urinary-albumin and renal-function results separate. - Conditions for verification: Keep the page's renal-function target separate from the trial's primary urinary-albumin endpoint, and indicate the gap in comparison with the original plan. - Why this condition is needed: Required to avoid automatically transferring a reduction in urinary albumin to improved renal function or inhibition of long-term progression. - Application exceptions: GFR being this page's target does not mean it was preregistered as the trial's primary endpoint. - Remaining uncertainty: The distinction between the roles of the two endpoints agrees with the retained manuscript. Comparison of the prespecified hierarchy with the original registry/plan separately remains unverified. - Referenced methods: Chamgap's own adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/missing data, precision and interpretation of harms. This is not formal implementation or certification of those methods. - Related sources: S01 ### N13 · Have the baseline and 3-month end means±SD been retained unchanged? Verification status: Met Reading scope: Only the designated retained stored summaries were actually read. External full texts/abstracts/tables/registries and old separate files have not been read in the current work. - Current findings: The baseline means±SD in the retained original S01 table are thiamine 85±19 and placebo 93±23 mL/min. The 3-month end means±SD are 90±30 and 97±18 mL/min. These are all arm-specific marginal means and SD, distinct from change SD and between-group CI. Analyzed/completer denominators remain null. - Why unverified: The attribution of the retained means, SD, units and time points has been verified. This does not mean that efficacy criteria have been met or analyzed denominators verified. - Reason for missing information: The attribution of the retained means, SD, units and time points has been verified. This does not mean that efficacy criteria have been met or analyzed denominators verified. - Required materials and conditions: S01 Table1: baseline/end means and SD by arm, units, time points and exact analyzed denominators - Materials to obtain first: S01 Table1: baseline/end means and SD by arm, units, time points and exact analyzed denominators - Further research: Extract the original table together with the analyzed denominator at each time point and the definition of dispersion. - Conditions for verification: Assign the original retained arm-specific means/SD to the correct time points/units, leaving gaps in analyzed denominators. - Why this condition is needed: Required to avoid turning arm-specific baseline/end values and SD into change SD or causal-effect intervals. - Application exceptions: Do not fill in analyzed denominators from the 20/20 allocation or newly calculate the difference between the two time points. - Remaining uncertainty: The attribution of the retained means, SD, units and time points has been verified. This does not mean that efficacy criteria have been met or analyzed denominators verified. - Referenced methods: Chamgap's own adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/missing data, precision and interpretation of harms. This is not formal implementation or certification of those methods. - Related sources: S01 ### N14 · Have the historical end-mean difference and the adjusted effect been distinguished? Verification status: Partly verified Reading scope: Only the designated retained stored summaries were actually read. External full texts/abstracts/tables/registries and old separate files have not been read in the current work. - Current findings: The existing unadjusted end-mean difference is −7 mL/min. With baseline means of 85 versus 93, this value is not interpreted as a causal effect or harm. The originally reported between-group estimate, baseline-adjusted effect and CI are null, and no calculation was created in the current work. - Why unverified: The descriptive difference has a defined boundary, but the original estimate/model needed to answer the causal between-group magnitude is unavailable. - Reason for missing information: The descriptive difference has a defined boundary, but the original estimate/model needed to answer the causal between-group magnitude is unavailable. - Required materials and conditions: Originally reported between-group estimate; baseline-adjusted model; effect of interest; analysis population; interval - Materials to obtain first: Originally reported between-group estimate; baseline-adjusted model; effect of interest; analysis population; interval - Further research: Compare effect magnitude only when the original adjusted model, between-group estimate and analyzed denominators have been obtained. - Conditions for verification: Record the historical unadjusted end-mean difference separately from the unverified adjusted causal effect/interval. - Why this condition is needed: Required to avoid interpreting a simple difference in end means with baseline differences as thiamine's causal effect or harm. - Application exceptions: −7 is existing descriptive arithmetic in the manuscript, not a value calculated, estimated or prescribed in the current work. - Remaining uncertainty: The descriptive difference has a defined boundary, but the original estimate/model needed to answer the causal between-group magnitude is unavailable. - Referenced methods: Chamgap's own adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/missing data, precision and interpretation of harms. This is not formal implementation or certification of those methods. - Related sources: S01 ### N15 · Have the 20/20 allocation and actual GFR analyzed/completer denominators been distinguished? Verification status: Unverified Reading scope: Only the designated retained stored summaries were actually read. External full texts/abstracts/tables/registries and old separate files have not been read in the current work. - Current findings: Randomization involved 40 participants, 20/20. Analysis exclusion of 1 participant with very high baseline/urinary thiamine and possible prior supplementation is reported, but the arm and scope of applicability to GFR analysis remain unverified. GFR analyzed/completer denominators were not filled in as 20/20 or 19/20. - Why unverified: The actual arm-specific analyzed/completer denominators for the selected GFR result cannot be established. - Reason for missing information: The actual arm-specific analyzed/completer denominators for the selected GFR result cannot be established. - Required materials and conditions: Numbers randomized, completing and analyzed for GFR by arm; the arm and scope of applicability of the 1-person exclusion - Materials to obtain first: Numbers randomized, completing and analyzed for GFR by arm; the arm and scope of applicability of the 1-person exclusion - Further research: Compare the original flow diagram and analysis exclusions with the arm-specific denominators in the GFR table. - Conditions for verification: Distinguish allocation from analysis/completion, and preserve unverified denominators as null. - Why this condition is needed: Required to avoid automatically using the 40 randomized participants as 40 analyzed participants or as 20/20 outcome denominators. - Application exceptions: From the existing record of 1 participant excluded from analysis, do not infer that an arm had 19 participants. - Remaining uncertainty: The actual arm-specific analyzed/completer denominators for the selected GFR result cannot be established. - Referenced methods: Chamgap's own adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/missing data, precision and interpretation of harms. This is not formal implementation or certification of those methods. - Related sources: S01 ### N16 · Have GFR missing data, analysis populations and change variance been verified? Verification status: Unverified Reading scope: Only the designated retained stored summaries were actually read. External full texts/abstracts/tables/registries and old separate files have not been read in the current work. - Current findings: Beyond the exclusion of 1 participant, arm-specific GFR missing-data handling and analysis populations remain unverified. Paired-change SD and baseline–follow-up correlation are also null. Do not use arm-specific marginal SD as change SD or establish ITT without the original source. - Why unverified: Missing-data handling, analysis populations and change variance are unavailable, so the effect/interval cannot be reconstructed. - Reason for missing information: Missing-data handling, analysis populations and change variance are unavailable, so the effect/interval cannot be reconstructed. - Required materials and conditions: ITT/PP; handling of attrition/missing data; outcome-specific application of exclusions; paired-change SD/correlation - Materials to obtain first: ITT/PP; handling of attrition/missing data; outcome-specific application of exclusions; paired-change SD/correlation - Further research: Link the original analysis population, missing-data/sensitivity handling and change variance to the outcome of interest. - Conditions for verification: Retain the reported exclusion and unverified analysis/missing data and paired variance, without creating new estimates. - Why this condition is needed: Required to avoid reconstructing missing-data handling or change CI from known marginal SD and randomized numbers. - Application exceptions: Do not label the analysis population ITT without the original source. - Remaining uncertainty: Missing-data handling, analysis populations and change variance are unavailable, so the effect/interval cannot be reconstructed. - Referenced methods: Chamgap's own adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/missing data, precision and interpretation of harms. This is not formal implementation or certification of those methods. - Related sources: S01 ### N17 · Have the exact P, CI and clinical importance been verified? Verification status: Unverified Reading scope: Only the designated retained stored summaries were actually read. External full texts/abstracts/tables/registries and old separate files have not been read in the current work. - Current findings: The exact GFR P, CI, adjusted effect and MCID are null. Intervals were not reconstructed merely because arm-specific SD are available. These data do not support saying that clinically important benefit has been excluded or harm established. - Why unverified: The original estimates/intervals/criteria needed to interpret precision and importance remain unverified. - Reason for missing information: The original estimates/intervals/criteria needed to interpret precision and importance remain unverified. - Required materials and conditions: Original GFR between-group estimate/exact P and CI; justified important difference; denominators/model - Materials to obtain first: Original GFR between-group estimate/exact P and CI; justified important difference; denominators/model - Further research: Obtain the original estimate, CI, exact P and endpoint-specific basis for importance to review the scope of interpretation. - Conditions for verification: Link the original intervals/importance criteria, or indicate why interpretation is not possible. - Why this condition is needed: Required to avoid concluding an effect of 0, exclusion of clinical benefit or equivalence from the word nonsignificant alone. - Application exceptions: Do not propose arbitrary numbers for sample size, duration or the minimum important difference. - Remaining uncertainty: The original estimates/intervals/criteria needed to interpret precision and importance remain unverified. - Referenced methods: Chamgap's own adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/missing data, precision and interpretation of harms. This is not formal implementation or certification of those methods. - Related sources: S01 ### N18 · Has a nonsignificant result been kept from being recast as an effect of 0 or equivalence? Verification status: Met Reading scope: Only the designated retained stored summaries were actually read. External full texts/abstracts/tables/registries and old separate files have not been read in the current work. - Current findings: The authors reported no statistically significant effect on GFR during treatment. The manuscript did not strengthen this to a true effect of 0, equivalence, exclusion of clinical benefit or exclusion of inhibition of long-term progression. It also retained the gap in exact effect magnitude. - Why unverified: The distinction between nonsignificance and uncertainty agrees with the retained original text. This is not a finding that efficacy criteria are met. - Reason for missing information: The distinction between nonsignificance and uncertainty agrees with the retained original text. This is not a finding that efficacy criteria are met. - Required materials and conditions: Original report of nonsignificant renal-function results; unverified estimates/CI; separate evidence for equivalence/exclusion of benefit - Materials to obtain first: Original report of nonsignificant renal-function results; unverified estimates/CI; separate evidence for equivalence/exclusion of benefit - Further research: Review the original nonsignificant results together with intervals/denominators, avoiding an inaccurate interpretation as an effect of 0. - Conditions for verification: Preserve the reported direction together with uncertainty, distinguishing them from a true effect of 0, equivalence or exclusion of benefit. - Why this condition is needed: Required to avoid strengthening verified nonsignificant results into definitive favorable or unfavorable conclusions. - Application exceptions: Retain the record of nonsignificance, but do not use it to assign a new efficacy/safety grade. - Remaining uncertainty: The distinction between nonsignificance and uncertainty agrees with the retained original text. This is not a finding that efficacy criteria are met. - Referenced methods: Chamgap's own adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/missing data, precision and interpretation of harms. This is not formal implementation or certification of those methods. - Related sources: S01 ### N19 · Have reports, mirrors and companion reports been kept from being summed as independent trials? Verification status: Partly verified Reading scope: Only the designated retained stored summaries were actually read. External full texts/abstracts/tables/registries and old separate files have not been read in the current work. - Current findings: For the locked 3-month CG result, the sole direct family at the time was TF01. Publisher PDF/HTML, PubMed and author uploads are mirrors, while S03/04 are correspondence. Participant-level overlap in the S05–08 companion reports is unresolved, so no additional replications or participants were counted. - Why unverified: Direct families and mirrors are distinguished, but exact cohort links for companion reports remain unverified. - Reason for missing information: Direct families and mirrors are distinguished, but exact cohort links for companion reports remain unverified. - Required materials and conditions: TF01–TF08 families; original articles/mirrors; correspondence/companion reports; links for overlapping denominators/results - Materials to obtain first: TF01–TF08 families; original articles/mirrors; correspondence/companion reports; links for overlapping denominators/results - Further research: Compare family/registry/report/result/participant relationships to separate independent comparisons from potential overlaps. - Conditions for verification: Distinguish verified families from provisional links, and preserve only their contributions to the direct locked result. - Why this condition is needed: Required to avoid counting publisher/PubMed/author mirrors and companion analyses as independent replications/participants. - Application exceptions: Do not turn unverified participant overlap in companion reports into confirmation of either the same cohort or a different trial. - Remaining uncertainty: Direct families and mirrors are distinguished, but exact cohort links for companion reports remain unverified. - Referenced methods: Chamgap's own adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/missing data, precision and interpretation of harms. This is not formal implementation or certification of those methods. - Related sources: S01, S03, S04, S05, S06, S07, S08 ### N20 · Have the substantive content of the critical letter and the unread reply been distinguished? Verification status: Partly verified Reading scope: Only the designated retained stored summaries were actually read. External full texts/abstracts/tables/registries and old separate files have not been read in the current work. - Current findings: S03 is a critical letter on background treatment and urinary-albumin summaries/interpretation, not a correction, retraction or new trial. The body of the S04 reply was unread at the time. Do not assume that a difference of medians equals the median of individual changes or state that the authors' substantive response was verified. - Why unverified: The role of the critique has been verified, but the actual arguments in the reply remain unverified. - Reason for missing information: The role of the critique has been verified, but the actual arguments in the reply remain unverified. - Required materials and conditions: S03 critique/endpoint interpretation; S04 full reply; distinction between correspondence and corrections/retractions - Materials to obtain first: S03 critique/endpoint interpretation; S04 full reply; distinction between correspondence and corrections/retractions - Further research: Compare the full reply with the points in the original critique by endpoint, checking actual correction events separately. - Conditions for verification: Keep the scope of the verified critique separate from that of the unread reply. - Why this condition is needed: Required to avoid claiming that the authors' substantive reply was read or turning correspondence into a new trial/correction. - Application exceptions: Do not automatically transfer the issue concerning urinary-albumin medians to an error in the GFR result. - Remaining uncertainty: The role of the critique has been verified, but the actual arguments in the reply remain unverified. - Referenced methods: Chamgap's own adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/missing data, precision and interpretation of harms. This is not formal implementation or certification of those methods. - Related sources: S03, S04 ### N21 · Have the same participants and additional results in S05–S08 been verified? Verification status: Unverified Reading scope: Only the designated retained stored summaries were actually read. External full texts/abstracts/tables/registries and old separate files have not been read in the current work. - Current findings: S05 risk-factor, S06 transketolase, S07 protein-marker and S08 enzyme reports are companion discovery materials. Some registry leads exist, but recruitment wording differs, so they are neither established as the same 40 participants nor counted as independent additional participants. Do not read the S08 repository upload date as the year of a new trial. - Why unverified: Full texts, participant-level links and additional contributions to the direct CG result remain unverified. - Reason for missing information: Full texts, participant-level links and additional contributions to the direct CG result remain unverified. - Required materials and conditions: Registration, recruitment, populations and denominators; participant/result links between reports - Materials to obtain first: Registration, recruitment, populations and denominators; participant/result links between reports - Further research: Compare full companion reports, recruitment/registration and denominators to verify cohort links. - Conditions for verification: Separate verified links from unverified participant-level overlap. - Why this condition is needed: Required to avoid adding companion analyses as new participants or direct replications. - Application exceptions: Do not establish that all of the same 40 participants were included solely from a shared registry lead. - Remaining uncertainty: Full texts, participant-level links and additional contributions to the direct CG result remain unverified. - Referenced methods: Chamgap's own adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/missing data, precision and interpretation of harms. This is not formal implementation or certification of those methods. - Related sources: S05, S06, S07, S08 ### N22 · Have a printed registration number and actual reading of the registry/plan been distinguished? Verification status: Unverified Reading scope: Only the designated retained stored summaries were actually read. External full texts/abstracts/tables/registries and old separate files have not been read in the current work. - Current findings: S01 prints CTRI2008/091/000112. The official S15 lookup at the time did not obtain the actual registry record because of a human-verification barrier. Registration dates and comparisons of plans/analyses/hierarchy remain unverified; no conclusion of nonregistration is drawn. - Why unverified: Beyond the number, the actual original registry and plan contents remain unread/unverified. - Reason for missing information: Beyond the number, the actual original registry and plan contents remain unread/unverified. - Required materials and conditions: CTRI2008/091/000112 actual registry record, dates, original protocol/SAP and outcome hierarchy - Materials to obtain first: CTRI2008/091/000112 actual registry record, dates, original protocol/SAP and outcome hierarchy - Further research: In an authorized update, link the actual registry/plan and change history to the outcome hierarchy. - Conditions for verification: Record the reported number, actual failure/nonreading and gaps in the prespecified hierarchy. - Why this condition is needed: Required to avoid turning a printed number into comparison with the entire registry record or verification of the prespecified hierarchy. - Application exceptions: Do not use an access barrier as evidence of nonregistration. - Remaining uncertainty: Beyond the number, the actual original registry and plan contents remain unread/unverified. - Referenced methods: Chamgap's own adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/missing data, precision and interpretation of harms. This is not formal implementation or certification of those methods. - Related sources: S01, S15 ### N23 · Have the levels of verification of public funding and conflict-of-interest declarations been distinguished? Verification status: Partly verified Reading scope: Only the designated retained stored summaries were actually read. External full texts/abstracts/tables/registries and old separate files have not been read in the current work. - Current findings: S01 records public/nonprofit support from Pakistan's HEC, a Warwick doctoral programme and the British Heart Foundation, along with a declaration of no conflicts of interest. Product provision/involvement and an independent audit remain unverified. Do not turn declarations into independent replication or certification of absence of bias. - Why unverified: Reported funding/declarations are available, but product involvement and independent verification remain unverified. - Reason for missing information: Reported funding/declarations are available, but product involvement and independent verification remain unverified. - Required materials and conditions: Reported funding; product provision/involvement; author relationships; scope of independent verification - Materials to obtain first: Reported funding; product provision/involvement; author relationships; scope of independent verification - Further research: Compare original funding, product provision and relationships, and review independent replication separately. - Conditions for verification: Retain reported declarations together with gaps in product involvement/independent verification. - Why this condition is needed: Required to avoid turning reported declarations into an independent audit of implementation or replication. - Application exceptions: Do not automatically exclude results or establish absence of bias solely from funding. - Remaining uncertainty: Reported funding/declarations are available, but product involvement and independent verification remain unverified. - Referenced methods: Chamgap's own adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/missing data, precision and interpretation of harms. This is not formal implementation or certification of those methods. - Related sources: S01 ### N24 · What do the different stage, duration and eGFR change in S02 answer? Verification status: Partly verified Reading scope: Only the designated retained stored summaries were actually read. External full texts/abstracts/tables/registries and old separate files have not been read in the current work. - Current findings: S02 is a study in type 2 diabetes and CKD3 lasting 24 weeks, with 35 participants allocated 18/17. Preserve median eGFR changes of 1.59 versus 1.78 mL/min/1.73m² and the existing difference of −0.19 and P=0.61. Actual route, adult age, salt/product and analyzed denominators/CI remain unverified within the abstract's scope. An annual slope or equivalence was not verified. - Why unverified: Adjacent numerical results are available, but actual exposure/denominators, precision and direct comparability remain unverified. - Reason for missing information: Adjacent numerical results are available, but actual exposure/denominators, precision and direct comparability remain unverified. - Required materials and conditions: S02 actual population, exposure/salt, definition of change over 24 weeks, analyzed denominators and original estimate/CI - Materials to obtain first: S02 actual population, exposure/salt, definition of change over 24 weeks, analyzed denominators and original estimate/CI - Further research: Verify actual exposure, change, denominators/intervals in the adjacent full text and review them as a separate question. - Conditions for verification: Indicate the scope of the adjacent abstract and the unverified exposure/denominators and precision. - Why this condition is needed: Required to avoid transferring results with a different measure and duration into direct replication of the 3-month CG result. - Application exceptions: Do not fill in analyzed denominators from the randomization of 35 participants, 18/17. - Remaining uncertainty: Adjacent numerical results are available, but actual exposure/denominators, precision and direct comparability remain unverified. - Referenced methods: Chamgap's own adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/missing data, precision and interpretation of harms. This is not formal implementation or certification of those methods. - Related sources: S02 ### N25 · Have S02 and S22 been kept from being counted as different trials? Verification status: Met Reading scope: Only the designated retained stored summaries were actually read. External full texts/abstracts/tables/registries and old separate files have not been read in the current work. - Current findings: Preserve the S02 online date of 2025-06-12 and print publication record of 2026. The S22 KKU bibliographic entry refers to the same TF02 and is not an additional trial. TF02 concerns change in body-surface-area-adjusted eGFR over 24 weeks, distinct from direct replication of the CG end mean at 3 months. - Why unverified: This verifies bibliographic/family and measure boundaries, not the adjacent effect. - Reason for missing information: This verifies bibliographic/family and measure boundaries, not the adjacent effect. - Required materials and conditions: Online/print dates, DOI/institutional bibliography and links to the same TF02 report - Materials to obtain first: Online/print dates, DOI/institutional bibliography and links to the same TF02 report - Further research: Retain links to the same DOI/report, and verify any new independent comparison separately. - Conditions for verification: Distinguish the bibliography of the same TF02 report and its different measure/duration relative to the locked question. - Why this condition is needed: Required to avoid adding an institutional bibliographic entry as an independent replication. - Application exceptions: Do not arbitrarily harmonize the 2025 online and 2026 print publication years into a single year. - Remaining uncertainty: This verifies bibliographic/family and measure boundaries, not the adjacent effect. - Referenced methods: Chamgap's own adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/missing data, precision and interpretation of harms. This is not formal implementation or certification of those methods. - Related sources: S02, S22 ### N26 · Has the relationship between the review's 0.31 estimate and the original end means been verified? Verification status: Unverified Reading scope: Only the designated retained stored summaries were actually read. External full texts/abstracts/tables/registries and old separate files have not been read in the current work. - Current findings: In the S12 review, GFR MD0.31 and CI[−4.51,5.13] do not directly correspond to the descriptive difference between the original end means of 90 versus 97. The possibility of a different estimand, change or additional data remains unresolved. They were not automatically judged to represent the same effect or a review error/conflicting information. - Why unverified: The actual analysis/data provenance of the review estimate remains unverified. - Reason for missing information: The actual analysis/data provenance of the review estimate remains unverified. - Required materials and conditions: S12 estimand, denominators, additional-data/change definitions and links to original results - Materials to obtain first: S12 estimand, denominators, additional-data/change definitions and links to original results - Further research: Compare the review's extraction table, estimand and additional data with the original results. - Conditions for verification: Retain the unverified link between the review's MD/CI and the original end means. - Why this condition is needed: Required to avoid removing the possibility of a different analysis and automatically declaring an error or the same effect. - Application exceptions: Do not declare a review error or conflicting information solely from the current difference. - Remaining uncertainty: The actual analysis/data provenance of the review estimate remains unverified. - Referenced methods: Chamgap's own adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/missing data, precision and interpretation of harms. This is not formal implementation or certification of those methods. - Related sources: S01, S12 ### N27 · Has benfotiamine been transferred into a direct effect of ordinary thiamine? Verification status: Does not apply Reading scope: Only the designated retained stored summaries were actually read. External full texts/abstracts/tables/registries and old separate files have not been read in the current work. - Current findings: S09 Alkhalaf2010 concerns benfotiamine, TF03. Preserve the access limitations for the primary abstract/full text at the time. Do not import its effects, safety or denominators into the ordinary-thiamine CG result at 3 months. - Why unverified: Because it is a different molecule, it does not meet the conditions of the locked direct comparison. - Reason for missing information: Because it is a different molecule, it does not meet the conditions of the locked direct comparison. - Required materials and conditions: Distinctions between molecule/exposure, endpoints and trial families - Materials to obtain first: Distinctions between molecule/exposure, endpoints and trial families - Further research: Check the relevant original materials when separately reviewing a question about the derivative. - Conditions for verification: Exclude the different derivative TF03 from the locked direct comparison. - Why this condition is needed: Required to avoid attributing results and safety for other derivatives to ordinary thiamine. - Application exceptions: Retain the historical access limitations for S09. - Remaining uncertainty: Because it is a different molecule, it does not meet the conditions of the locked direct comparison. - Referenced methods: Chamgap's own adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/missing data, precision and interpretation of harms. This is not formal implementation or certification of those methods. - Related sources: S09 ### N28 · Has the individual contribution been verified from combination products or multinutrient registry records? Verification status: Does not apply Reading scope: Only the designated retained stored summaries were actually read. External full texts/abstracts/tables/registries and old separate files have not been read in the current work. - Current findings: S10 concerns thiamine+folic-acid cognition data in maintenance hemodialysis. S18 NCT01473914 is a registry index record for multinutrient/trace-element supplementation. Neither is a direct CG comparison of single-ingredient ordinary thiamine in early diabetic nephropathy. - Why unverified: The combination, dialysis and endpoint/registry boundaries differ, so these do not apply to the direct locked comparison. - Reason for missing information: The combination, dialysis and endpoint/registry boundaries differ, so these do not apply to the direct locked comparison. - Required materials and conditions: Combination ingredients; dialysis population; cognition/other endpoints; distinction between registry records and results - Materials to obtain first: Combination ingredients; dialysis population; cognition/other endpoints; distinction between registry records and results - Further research: For combination/dialysis questions, separately review the results and whether the individual contribution can be identified. - Conditions for verification: Separate S10 combination cognition data and the S18 multinutrient registry record from the locked direct comparison. - Why this condition is needed: Required to avoid turning combination results into the renal-function contribution of single-ingredient ordinary thiamine. - Application exceptions: Do not label a registry index record as completed results. - Remaining uncertainty: The combination, dialysis and endpoint/registry boundaries differ, so these do not apply to the direct locked comparison. - Referenced methods: Chamgap's own adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/missing data, precision and interpretation of harms. This is not formal implementation or certification of those methods. - Related sources: S10, S18 ### N29 · Have status associations, acute AKI and animal data been transferred into chronic oral effects? Verification status: Does not apply Reading scope: Only the designated retained stored summaries were actually read. External full texts/abstracts/tables/registries and old separate files have not been read in the current work. - Current findings: S19 concerns observational thiamine-status data in ESRD, S20 associations in critically ill patients with AKI, and S21 animal CKD transporter data. Do not count them as causal renal-function effects of chronic oral ordinary thiamine in humans or as additional direct families/participants. - Why unverified: The designs and populations/exposures differ, so these do not apply to the locked direct comparison. - Reason for missing information: The designs and populations/exposures differ, so these do not apply to the locked direct comparison. - Required materials and conditions: Distinctions between population/design, exposure, endpoints and data roles - Materials to obtain first: Distinctions between population/design, exposure, endpoints and data roles - Further research: For each separate question, verify eligible direct materials and the scope actually read. - Conditions for verification: Retain the design and population differences in S19–S21. - Why this condition is needed: Required to avoid calling observational/acute/animal data a causal effect of chronic oral treatment in humans. - Application exceptions: Do not expand the scope of index/abstract reading into full-text review. - Remaining uncertainty: The designs and populations/exposures differ, so these do not apply to the locked direct comparison. - Referenced methods: Chamgap's own adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/missing data, precision and interpretation of harms. This is not formal implementation or certification of those methods. - Related sources: S19, S20, S21 ### N30 · Do single-dose 100 mg data in ESRD answer chronic 300 mg safety? Verification status: Partly verified Reading scope: Only the designated retained stored summaries were actually read. External full texts/abstracts/tables/registries and old separate files have not been read in the current work. - Current findings: S11 is an abstract on pharmacokinetics in ESRD following a single oral dose of ordinary thiamine nitrate or benfotiamine, 100 mg, over 24 hours. It does not establish renal benefit, safety regarding accumulation, stage-specific doses or dialysis prescribing for chronic 300 mg ordinary thiamine. - Why unverified: Adjacent single-dose data are available, but the actual connection to chronic exposure/harms remains unverified. - Reason for missing information: Adjacent single-dose data are available, but the actual connection to chronic exposure/harms remains unverified. - Required materials and conditions: S11 actual molecule, single dose/24 hours and ESRD; distinction between concentration/excretion and chronic harms - Materials to obtain first: S11 actual molecule, single dose/24 hours and ESRD; distinction between concentration/excretion and chronic harms - Further research: Separately verify pharmacokinetic/harm data for the same molecule, stage and repeated exposure. - Conditions for verification: Separate the reported single-dose conditions from gaps concerning chronic harms/dose. - Why this condition is needed: Required to avoid turning pharmacokinetic exposure into chronic efficacy or prescribing by kidney-disease stage. - Application exceptions: Do not harmonize single-dose nitrate/benfotiamine with the trial's 300 mg regimen whose salt was not reported. - Remaining uncertainty: Adjacent single-dose data are available, but the actual connection to chronic exposure/harms remains unverified. - Referenced methods: Chamgap's own adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/missing data, precision and interpretation of harms. This is not formal implementation or certification of those methods. - Related sources: S11 ### N31 · Has the identity of the S13 SmPC product and the trial product been established as the same? Verification status: Partly verified Reading scope: Only the designated retained stored summaries were actually read. External full texts/abstracts/tables/registries and old separate files have not been read in the current work. - Current findings: S13 is the Flamingo UK thiamine hydrochloride 100 mg SmPC, PL43461/0038. Preserve the historical update record of 2025-09-08 and text revision of 2025-02-18. Do not use this product to identify the salt, manufacturer, excipients or stage-specific dose in S01. - Why unverified: Information on the separate product is available, but whether it is the same as the trial product and whether the version is current remain unverified. - Reason for missing information: Information on the separate product is available, but whether it is the same as the trial product and whether the version is current remain unverified. - Required materials and conditions: Authorized product identity, version, ingredients/warnings and whether it is the same as the trial product - Materials to obtain first: Authorized product identity, version, ingredients/warnings and whether it is the same as the trial product - Further research: Verify the relationship between the actual trial product and the authorized product, and the version/warnings. - Conditions for verification: Separate historical verification of the separate product from the unverified trial product. - Why this condition is needed: Required to avoid substituting a separate regulated product for the unreported trial product. - Application exceptions: Do not turn an authorized product's doses/warnings into an individual CKD prescription. - Remaining uncertainty: Information on the separate product is available, but whether it is the same as the trial product and whether the version is current remain unverified. - Referenced methods: Chamgap's own adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/missing data, precision and interpretation of harms. This is not formal implementation or certification of those methods. - Related sources: S01, S13 ### N32 · Does the absence of an established UL mean unlimited safety? Verification status: Partly verified Reading scope: Only the designated retained stored summaries were actually read. External full texts/abstracts/tables/registries and old separate files have not been read in the current work. - Current findings: Do not interpret the absence of an upper intake level in S14 NIH ODS as unlimited safety. Preserve the locations of the medication explanations for Furosemide and fluorouracil, but do not create incidence rates or high-dose CKD prescriptions. No UL does not mean unlimited safety. - Why unverified: Official context is available, but quantitative harms/interactions for the same exposure in CKD remain unverified. - Reason for missing information: Official context is available, but quantitative harms/interactions for the same exposure in CKD remain unverified. - Required materials and conditions: Insufficient data in the official explanation; medication/exposure context; version; harms in the actual population - Materials to obtain first: Insufficient data in the official explanation; medication/exposure context; version; harms in the actual population - Further research: Compare official explanations separately with harms for the actual exposure/population concerned. - Conditions for verification: Retain insufficient data and medication wording together with gaps in quantitative harms. - Why this condition is needed: Required to avoid turning the absence of an established UL into high-dose CKD safety or unrestricted intake. - Application exceptions: Do not use general explanations as direct CKD trials or prescribing guidance. - Remaining uncertainty: Official context is available, but quantitative harms/interactions for the same exposure in CKD remain unverified. - Referenced methods: Chamgap's own adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/missing data, precision and interpretation of harms. This is not formal implementation or certification of those methods. - Related sources: S14 ### N33 · Have denominators for adverse reactions, serious events and discontinuations been verified? Verification status: Unverified Reading scope: Only the designated retained stored summaries were actually read. External full texts/abstracts/tables/registries and old separate files have not been read in the current work. - Current findings: AE/SAE, discontinuations due to adverse reactions and exact exposure denominators/duration in the selected oral trial remain unverified. Do not describe insufficient reporting as 0 events or as certification of individual safety. Do not transfer parenteral reactions into oral incidence rates. - Why unverified: Arm-specific harm events, exposure and collection/discontinuation data remain unverified. - Reason for missing information: Arm-specific harm events, exposure and collection/discontinuation data remain unverified. - Required materials and conditions: Arm-specific AE/SAE for the same exposure; collection/duration; exposure denominators; reasons for discontinuation - Materials to obtain first: Arm-specific AE/SAE for the same exposure; collection/duration; exposure denominators; reasons for discontinuation - Further research: Verify arm-specific harm collection, denominators/duration and discontinuations for the same oral regimen. - Conditions for verification: Retain unverified events/denominators and duration for the original harms data. - Why this condition is needed: Required to avoid turning unverified quantitative harms into 0 events/0 risk. - Application exceptions: Do not transfer reactions to injectable products into oral incidence rates. - Remaining uncertainty: Arm-specific harm events, exposure and collection/discontinuation data remain unverified. - Referenced methods: Chamgap's own adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/missing data, precision and interpretation of harms. This is not formal implementation or certification of those methods. - Related sources: S01, S11, S13, S14 ### N34 · Have long-term accumulation and doses for special populations/by stage been verified? Verification status: Unverified Reading scope: Only the designated retained stored summaries were actually read. External full texts/abstracts/tables/registries and old separate files have not been read in the current work. - Current findings: Direct data on long-term high-dose CKD safety, accumulation, doses by kidney-disease stage and special populations/concomitant use remain unverified. Do not combine the mean at 3 months, single-dose ESRD pharmacokinetics and a separate authorized product into long-term/optimal-dose prescribing. - Why unverified: Long-term and stage-specific repeated-exposure/dose and special-population results remain unverified. - Reason for missing information: Long-term and stage-specific repeated-exposure/dose and special-population results remain unverified. - Required materials and conditions: Actual data on repeated/long-term exposure, accumulation, doses by kidney-disease stage and vulnerable populations/concomitant use - Materials to obtain first: Actual data on repeated/long-term exposure, accumulation, doses by kidney-disease stage and vulnerable populations/concomitant use - Further research: For extension questions, review harms and direct dose comparisons for the same molecule, stage and repeated exposure. - Conditions for verification: Indicate the scope for which direct long-term/special-population data are unavailable. - Why this condition is needed: Required to avoid extending a short-term pilot trial into long-term/stage-specific prescribing. - Application exceptions: Do not require all extension studies as prerequisites for the narrow question about the mean at 3 months. - Remaining uncertainty: Long-term and stage-specific repeated-exposure/dose and special-population results remain unverified. - Referenced methods: Chamgap's own adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/missing data, precision and interpretation of harms. This is not formal implementation or certification of those methods. - Related sources: S01, S11, S13, S14 ### N35 · Does the 3-month CG readout answer questions about annual slope or kidney-failure events? Verification status: Does not apply Reading scope: Only the designated retained stored summaries were actually read. External full texts/abstracts/tables/registries and old separate files have not been read in the current work. - Current findings: The annualized_slope for the original 3-month CG end mean is null. Do not extend a reduction in urinary albumin or this readout into preventing dialysis, kidney failure or death, or slowing long-term progression. These events differ from the currently selected endpoint. - Why unverified: This does not apply to the conditions of the currently selected readout, and direct data are needed for long-term-event claims. - Reason for missing information: This does not apply to the conditions of the currently selected readout, and direct data are needed for long-term-event claims. - Required materials and conditions: Direct endpoints of annual slope, dialysis/kidney failure/death in the same population/exposure - Materials to obtain first: Direct endpoints of annual slope, dialysis/kidney failure/death in the same population/exposure - Further research: For a long-term-progression question, review direct endpoints and adequate follow-up/denominators separately. - Conditions for verification: Do not claim annual slope and long-term events as direct locked results. - Why this condition is needed: Required to avoid turning a surrogate renal-function readout and urinary albumin into patient-centered inhibition of progression. - Application exceptions: Distinguish the status of the current narrow numerical question from that of the long-term-event question. - Remaining uncertainty: This does not apply to the conditions of the currently selected readout, and direct data are needed for long-term-event claims. - Referenced methods: Chamgap's own adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/missing data, precision and interpretation of harms. This is not formal implementation or certification of those methods. - Related sources: S01, S02 ### N36 · Has the actual body of NCT06322212 been read? Verification status: Unverified Reading scope: Only the designated retained stored summaries were actually read. External full texts/abstracts/tables/registries and old separate files have not been read in the current work. - Current findings: For S17 NCT06322212, the structured body was not obtained at the time because access yielded a JavaScript shell/API failure. Do not read CKD background descriptions as actual eligible populations/results or add eligible families/participants. - Why unverified: The actual registry body, eligibility/exposure and results remain unverified. - Reason for missing information: The actual registry body, eligibility/exposure and results remain unverified. - Required materials and conditions: Actual structured registry body; eligibility/exposure; results/status; original change history - Materials to obtain first: Actual structured registry body; eligibility/exposure; results/status; original change history - Further research: In an authorized update, verify the actual registry body and results/changes to reconsider the boundaries. - Conditions for verification: Distinguish the unacquired body and failed access from background/eligibility criteria. - Why this condition is needed: Required to avoid calling a JavaScript shell and CKD background descriptions actual participants/results. - Application exceptions: Do not automatically promote a registry lead to an eligible direct comparison or completed results. - Remaining uncertainty: The actual registry body, eligibility/exposure and results remain unverified. - Referenced methods: Chamgap's own adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/missing data, precision and interpretation of harms. This is not formal implementation or certification of those methods. - Related sources: S17 ### N37 · Have search attempts been distinguished from completed native-database/correction reviews? Verification status: Partly verified Reading scope: Only the designated retained stored summaries were actually read. External full texts/abstracts/tables/registries and old separate files have not been read in the current work. - Current findings: The original cutoff date is 2026-09-16, and the 41 general-web searches at that time were not an exhaustive native PubMed search. The S23 native query returned no result set because of an internal error, and S16 viewed only the Thai registry homepage. No external search, correction/retraction lookup or reading of the old qa/corrections.json was performed in the current work. - Why unverified: Current exhaustive checks, checks of unpublished results/corrections and incomplete native searches remain outstanding. - Reason for missing information: Current exhaustive checks, checks of unpublished results/corrections and incomplete native searches remain outstanding. - Required materials and conditions: Cutoff date; search routes/results; actual scope of negative/unpublished results, registry records and corrections/retractions - Materials to obtain first: Cutoff date; search routes/results; actual scope of negative/unpublished results, registry records and corrections/retractions - Further research: In a separately authorized update, record actual search/registry/correction results and the scope of failures. - Conditions for verification: Distinguish the historical 41 general-web searches from incomplete native lookups and the current local conversion. - Why this condition is needed: Required to avoid turning search errors, homepages and existing routes into exhaustive searches or current correction reviews. - Application exceptions: No new search in the current work does not mean 0 studies or no recent corrections. - Remaining uncertainty: Current exhaustive checks, checks of unpublished results/corrections and incomplete native searches remain outstanding. - Referenced methods: Chamgap's own adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/missing data, precision and interpretation of harms. This is not formal implementation or certification of those methods. - Related sources: S15, S16, S23 ### N38 · Are the existing D30 and document A being read as new clinical verification? Verification status: Met Reading scope: Only the designated retained stored summaries were actually read. External full texts/abstracts/tables/registries and old separate files have not been read in the current work. - Current findings: Preserve the existing D, 30 and Caution and the original verdict, including axes such as E0/CX. Document A and self-checking by the same model are not independent clinical review or efficacy/safety certification. The current work converted stored materials into a table; no new grade, score or clinical calculation was created. - Why unverified: This verifies the distinction between original values and document roles, not a new clinical verdict. - Reason for missing information: This verifies the distinction between original values and document roles, not a new clinical verdict. - Required materials and conditions: Original grade/score; document assessment; verification actor; actual scope of conversion - Materials to obtain first: Original grade/score; document assessment; verification actor; actual scope of conversion - Further research: If a new evidence event is authorized, link a separate version/decision to the clinical evidence. - Conditions for verification: Preserve the original D30/Caution and document/self-checking records as historical values. - Why this condition is needed: Required to separate document self-checking from clinical/safety certification. - Application exceptions: Do not use the current table's statuses/counts as a new efficacy score. - Remaining uncertainty: This verifies the distinction between original values and document roles, not a new clinical verdict. - Referenced methods: Chamgap's own adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/missing data, precision and interpretation of harms. This is not formal implementation or certification of those methods. - Related sources: S01 ### N39 · Are summary links and past publication metadata being read as verification of current original sources/publication? Verification status: Met Reading scope: Only the designated retained stored summaries were actually read. External full texts/abstracts/tables/registries and old separate files have not been read in the current work. - Current findings: Preserve the current 3121 identity, original URL, cutoff/publication and deployment metadata of 2026-09-16, and revision history. What was read in the current work was the local stored summary; historical access differs among the 23 provenance entries. All local_original_copy values are null. Summary links connect to retained locations/values/SHA, without claiming current external full-text reading or public publication in the current work. - Why unverified: This verifies preservation/linking conditions. External original bytes, current versions and new corrections/publication remain unverified. - Reason for missing information: This verifies preservation/linking conditions. External original bytes, current versions and new corrections/publication remain unverified. - Required materials and conditions: ID/URL; dates/revisions; historical/current reading by material; exact pointer/literal/SHA; update links - Materials to obtain first: ID/URL; dates/revisions; historical/current reading by material; exact pointer/literal/SHA; update links - Further research: When new materials arrive, preserve everything before changes and reconsider the relevant rows, materials, criteria version and change decision. - Conditions for verification: Link to the exact stored summary, and indicate current nonreading of external materials and local nonpublication. - Why this condition is needed: Required to distinguish reading retained stored summaries from external clinical originals/public publication in the current work. - Application exceptions: Do not use a local stored-summary SHA as the hash of an external PDF's original bytes. - Remaining uncertainty: This verifies preservation/linking conditions. External original bytes, current versions and new corrections/publication remain unverified. - Referenced methods: Chamgap's own adaptation of the retained M03/M04/M08/M15/M19 principles on questions, families, measurement/missing data, precision and interpretation of harms. This is not formal implementation or certification of those methods. - Related sources: S01, S02, S03, S04, S11, S12, S13, S14 ## Evidence and sources ### S01 Rabbani et al. High-dose thiamine therapy for patients with type 2 diabetes and microalbuminuria: a randomised, double-blind placebo-controlled pilot study [Source](https://link.springer.com/content/pdf/10.1007/s00125-008-1224-4.pdf) Materials actually read: The designated retained stored summaries were actually read. External/old separate originals have not been read in the current work. Findings recorded in the summary: This is one trial. Author uploads, publisher HTML, PDF and PubMed are not counted as separate replications. Salt and exact analyzed denominators remain unverified. Thiamine 90±30, placebo 97±18 mL/min; unadjusted end-mean difference −7 mL/min. No significant improvement was reported, and exact CI and P remain unverified. Randomized 20/20; the arm of the 1 participant excluded from analysis and GFR analyzed/completer denominators remain unverified. The only direct trial family for the locked endpoint; not extended to a causal effect, equivalence or inhibition of long-term progression. Record level: A stored summary within the scope of historical extraction/access; this is not new verification of original clinical materials in the current work. Independent replication: Distinguish actual report roles/families from access attempts, and do not count the 23 entries as 23 clinical trials. | Material | Public availability | Access status | Actually read | Notes | |---|---|---|---|---| | Original article PDF/HTML | Unverified (no external lookup in the current work) | Access not attempted | Not read | Distinguish historical success/failure from current nonattempted access and reading of retained stored summaries | ### S02 Phrawong et al. Thiamine for Increasing Estimated Glomerular Filtration Rate in Type 2 Diabetes Mellitus with Chronic Kidney Disease Stage 3: A Randomized Controlled Trial [Source](https://www.benthamscience.com/article/148808) Materials actually read: The designated retained stored summaries were actually read. External/old separate originals have not been read in the current work. Findings recorded in the summary: The route was not explicitly stated in the abstract, and adult age criteria, salt, composition, analyzed denominators and CI were not verified. This is a between-group difference in median changes at 24 weeks, not a slope. 1.59 versus 1.78 mL/min/1.73 m², difference −0.19, P=0.61; CI unverified. Randomized 18/17; analyzed/completer denominators unverified. Endpoint, time point and boundaries differ; not summed as a direct replication, and efficacy axes are not borrowed. Record level: A stored summary within the scope of historical extraction/access; this is not new verification of original clinical materials in the current work. Independent replication: Distinguish actual report roles/families from access attempts, and do not count the 23 entries as 23 clinical trials. | Material | Public availability | Access status | Actually read | Notes | |---|---|---|---|---| | Publisher abstract, bibliography and graphical abstract | Unverified (no external lookup in the current work) | Access not attempted | Not read | Distinguish historical success/failure from current nonattempted access and reading of retained stored summaries | ### S03 Alkhalaf et al. Thiamine in diabetic nephropathy: a novel treatment modality? [Source](https://link.springer.com/article/10.1007/s00125-009-1326-7) Materials actually read: The designated retained stored summaries were actually read. External/old separate originals have not been read in the current work. Findings recorded in the summary: This is a critical letter, not a correction, retraction or new clinical trial. A difference of medians is not assumed to equal the median of individual changes. Record level: A stored summary within the scope of historical extraction/access; this is not new verification of original clinical materials in the current work. Independent replication: Distinguish actual report roles/families from access attempts, and do not count the 23 entries as 23 clinical trials. | Material | Public availability | Access status | Actually read | Notes | |---|---|---|---|---| | Critical letter HTML/PDF | Unverified (no external lookup in the current work) | Access not attempted | Not read | Distinguish historical success/failure from current nonattempted access and reading of retained stored summaries | ### S04 Rabbani et al. Thiamine in diabetic nephropathy: a novel treatment modality? Reply to Alkhalaf A, Kleefstra N, Groenier KH et al. [Source](https://link.springer.com/article/10.1007/s00125-009-1334-7) Materials actually read: The designated retained stored summaries were actually read. External/old separate originals have not been read in the current work. Findings recorded in the summary: The full reply was not read. Do not state that the authors' substantive response to the critique was verified. Record level: A stored summary within the scope of historical extraction/access; this is not new verification of original clinical materials in the current work. Independent replication: Distinguish actual report roles/families from access attempts, and do not count the 23 entries as 23 clinical trials. | Material | Public availability | Access status | Actually read | Notes | |---|---|---|---|---| | Reply preview/repository bibliography | Unverified (no external lookup in the current work) | Access not attempted | Not read | Distinguish historical success/failure from current nonattempted access and reading of retained stored summaries | ### S05 Alam et al. Effect of High Dose Thiamine Therapy on Risk Factors in Type 2 Diabetics [Source](https://www.iomcworld.com/open-access/effect-of-high-dose-thiamine-therapy-on-risk-factors-in-type-2-diabetics-26626.html) Materials actually read: The designated retained stored summaries were actually read. External/old separate originals have not been read in the current work. Findings recorded in the summary: A potential companion report with the same investigators, dose and duration. Participant-level overlap was not verified, so it was not counted as an independent replication or additional participants. Record level: A stored summary within the scope of historical extraction/access; this is not new verification of original clinical materials in the current work. Independent replication: Distinguish actual report roles/families from access attempts, and do not count the 23 entries as 23 clinical trials. | Material | Public availability | Access status | Actually read | Notes | |---|---|---|---|---| | Article index/abstract | Unverified (no external lookup in the current work) | Access not attempted | Not read | Distinguish historical success/failure from current nonattempted access and reading of retained stored summaries | ### S06 Alam et al. Effect of high dose thiamine therapy on activity and molecular aspects of transketolase in Type 2 diabetic patients [Source](https://www.researchgate.net/publication/228438546_Effect_of_high_dose_thiamine_therapy_on_activity_and_molecular_aspects_of_transketolase_in_Type_2_diabetic_patients) Materials actually read: The designated retained stored summaries were actually read. External/old separate originals have not been read in the current work. Findings recorded in the summary: Recruitment numbers are described differently from the 40-person trial, so it is not definitively merged as the same 40 participants. This is a registry-linked report with potential overlap, not counted as an independent replication of the renal-function endpoint. Record level: A stored summary within the scope of historical extraction/access; this is not new verification of original clinical materials in the current work. Independent replication: Distinguish actual report roles/families from access attempts, and do not count the 23 entries as 23 clinical trials. | Material | Public availability | Access status | Actually read | Notes | |---|---|---|---|---| | Article abstract/registry index | Unverified (no external lookup in the current work) | Access not attempted | Not read | Distinguish historical success/failure from current nonattempted access and reading of retained stored summaries | ### S07 Riaz et al. Effect of high dose thiamine on the levels of urinary protein biomarkers in diabetes mellitus type 2 [Source](https://www.ovid.com/journals/jpaba/fulltext/10.1016/j.jpba.2010.11.008~effect-of-high-dose-thiamine-on-the-levels-of-urinary) Materials actually read: The designated retained stored summaries were actually read. External/old separate originals have not been read in the current work. Findings recorded in the summary: These are protein biomarkers, not the locked renal-function endpoint. Potential overlap prevents counting additional participants. Record level: A stored summary within the scope of historical extraction/access; this is not new verification of original clinical materials in the current work. Independent replication: Distinguish actual report roles/families from access attempts, and do not count the 23 entries as 23 clinical trials. | Material | Public availability | Access status | Actually read | Notes | |---|---|---|---|---| | Article index excerpts | Unverified (no external lookup in the current work) | Access not attempted | Not read | Distinguish historical success/failure from current nonattempted access and reading of retained stored summaries | ### S08 Alam et al. thiamine / pyruvate dehydrogenase and alpha-ketoglutarate dehydrogenase report [Source](https://hal.science/hal-05496736v1) Materials actually read: The designated retained stored summaries were actually read. External/old separate originals have not been read in the current work. Findings recorded in the summary: The repository upload time is not treated as the year of a new trial. The full text was not read and is not used as evidence for decisive facts. Record level: A stored summary within the scope of historical extraction/access; this is not new verification of original clinical materials in the current work. Independent replication: Distinguish actual report roles/families from access attempts, and do not count the 23 entries as 23 clinical trials. | Material | Public availability | Access status | Actually read | Notes | |---|---|---|---|---| | Repository search index | Unverified (no external lookup in the current work) | Access not attempted | Not read | Distinguish historical success/failure from current nonattempted access and reading of retained stored summaries | ### S09 Alkhalaf et al. A Double-Blind, Randomized, Placebo-Controlled Clinical Trial on Benfotiamine Treatment in Patients With Diabetic Nephropathy [Source](https://pmc.ncbi.nlm.nih.gov/articles/PMC2890365/) Materials actually read: The designated retained stored summaries were actually read. External/old separate originals have not been read in the current work. Findings recorded in the summary: Benfotiamine is separate from ordinary thiamine. That trial's effects, denominators and safety are not imported into this page. Record level: A stored summary within the scope of historical extraction/access; this is not new verification of original clinical materials in the current work. Independent replication: Distinguish actual report roles/families from access attempts, and do not count the 23 entries as 23 clinical trials. | Material | Public availability | Access status | Actually read | Notes | |---|---|---|---|---| | Original article abstract | Unverified (no external lookup in the current work) | Access not attempted | Not read | Distinguish historical success/failure from current nonattempted access and reading of retained stored summaries | ### S10 Xie et al. A prospective, randomized, double-blind, placebo-controlled, multicenter study of thiamin plus folic acid in the treatment of cognitive impairment in patients undergoing maintenance hemodialysis [Source](https://pubmed.ncbi.nlm.nih.gov/42059045/) Materials actually read: The designated retained stored summaries were actually read. External/old separate originals have not been read in the current work. Findings recorded in the summary: This concerns thiamine+folic acid, maintenance hemodialysis and a cognitive endpoint. It is not counted as a renal-function replication for single-ingredient ordinary thiamine. Record level: A stored summary within the scope of historical extraction/access; this is not new verification of original clinical materials in the current work. Independent replication: Distinguish actual report roles/families from access attempts, and do not count the 23 entries as 23 clinical trials. | Material | Public availability | Access status | Actually read | Notes | |---|---|---|---|---| | Original article abstract/author's full-text copy | Unverified (no external lookup in the current work) | Access not attempted | Not read | Distinguish historical success/failure from current nonattempted access and reading of retained stored summaries | ### S11 Frank et al. Alteration of thiamine pharmacokinetics by end-stage renal disease (ESRD) [Source](https://pubmed.ncbi.nlm.nih.gov/10507244/) Materials actually read: The designated retained stored summaries were actually read. External/old separate originals have not been read in the current work. Findings recorded in the summary: This is a study of a single oral dose of 100 mg thiamine nitrate or benfotiamine, with pharmacokinetics over 24 hours. It does not establish long-term CKD safety, dose adjustment or renal-function efficacy at 300 mg/day. Record level: A stored summary within the scope of historical extraction/access; this is not new verification of original clinical materials in the current work. Independent replication: Distinguish actual report roles/families from access attempts, and do not count the 23 entries as 23 clinical trials. | Material | Public availability | Access status | Actually read | Notes | |---|---|---|---|---| | PubMed article abstract | Unverified (no external lookup in the current work) | Access not attempted | Not read | Distinguish historical success/failure from current nonattempted access and reading of retained stored summaries | ### S12 Raval et al. Vitamin B and its derivatives for diabetic kidney disease [Source](https://pmc.ncbi.nlm.nih.gov/articles/PMC11252721/) Materials actually read: The designated retained stored summaries were actually read. External/old separate originals have not been read in the current work. Findings recorded in the summary: The review's GFR MD 0.31 and CI −4.51~5.13 do not directly match the original table's end means. The estimand and provenance of additional data remain unverified, so these were not promoted to estimates verified against the original study. Record level: A stored summary within the scope of historical extraction/access; this is not new verification of original clinical materials in the current work. Independent replication: Distinguish actual report roles/families from access attempts, and do not count the 23 entries as 23 clinical trials. | Material | Public availability | Access status | Actually read | Notes | |---|---|---|---|---| | Review HTML | Unverified (no external lookup in the current work) | Access not attempted | Not read | Distinguish historical success/failure from current nonattempted access and reading of retained stored summaries | ### S13 Flamingo Pharma UK Ltd. Thiamine Hydrochloride 100 mg Tablets — Summary of Product Characteristics [Source](https://www.medicines.org.uk/emc/product/13528/smpc) Materials actually read: The designated retained stored summaries were actually read. External/old separate originals have not been read in the current work. Findings recorded in the summary: This is safety information for a separate authorized product and does not establish the trial product's salt, manufacturer or excipients. Record level: A stored summary within the scope of historical extraction/access; this is not new verification of original clinical materials in the current work. Independent replication: Distinguish actual report roles/families from access attempts, and do not count the 23 entries as 23 clinical trials. | Material | Public availability | Access status | Actually read | Notes | |---|---|---|---|---| | Authorized-product SmPC HTML | Unverified (no external lookup in the current work) | Access not attempted | Not read | Distinguish historical success/failure from current nonattempted access and reading of retained stored summaries | ### S14 NIH Office of Dietary Supplements. Thiamin — Fact Sheet for Health Professionals [Source](https://ods.od.nih.gov/factsheets/Thiamin-HealthProfessional/) Materials actually read: The designated retained stored summaries were actually read. External/old separate originals have not been read in the current work. Findings recorded in the summary: The absence of an upper intake level is not interpreted as unlimited safety. General nutritional information is not kidney-disease-specific dose prescribing. Record level: A stored summary within the scope of historical extraction/access; this is not new verification of original clinical materials in the current work. Independent replication: Distinguish actual report roles/families from access attempts, and do not count the 23 entries as 23 clinical trials. | Material | Public availability | Access status | Actually read | Notes | |---|---|---|---|---| | Official nutrition fact sheet HTML | Unverified (no external lookup in the current work) | Access not attempted | Not read | Distinguish historical success/failure from current nonattempted access and reading of retained stored summaries | ### S15 Clinical Trials Registry–India official portal [Source](https://ctri.nic.in/Clinicaltrials/searchbyctri.php) Materials actually read: The designated retained stored summaries were actually read. External/old separate originals have not been read in the current work. Findings recorded in the summary: A human-verification barrier in the search form prevented comparison of the actual registration date, primary endpoint and analysis plan. This does not mean that registration is absent. Record level: A stored summary within the scope of historical extraction/access; this is not new verification of original clinical materials in the current work. Independent replication: Distinguish actual report roles/families from access attempts, and do not count the 23 entries as 23 clinical trials. | Material | Public availability | Access status | Actually read | Notes | |---|---|---|---|---| | CTRI lookup screen/actual registry record | Unverified (no external lookup in the current work) | Access not attempted | Not read | Distinguish historical success/failure from current nonattempted access and reading of retained stored summaries | ### S16 Thai Clinical Trials Registry official portal [Source](https://www.thaiclinicaltrials.org/) Materials actually read: The designated retained stored summaries were actually read. External/old separate originals have not been read in the current work. Findings recorded in the summary: The Phrawong trial's registration number was not verified. Do not conclude that it was unregistered. Record level: A stored summary within the scope of historical extraction/access; this is not new verification of original clinical materials in the current work. Independent replication: Distinguish actual report roles/families from access attempts, and do not count the 23 entries as 23 clinical trials. | Material | Public availability | Access status | Actually read | Notes | |---|---|---|---|---| | Thai registry homepage/search results | Unverified (no external lookup in the current work) | Access not attempted | Not read | Distinguish historical success/failure from current nonattempted access and reading of retained stored summaries | ### S17 ClinicalTrials.gov NCT06322212 [Source](https://clinicaltrials.gov/study/NCT06322212) Materials actually read: The designated retained stored summaries were actually read. External/old separate originals have not been read in the current work. Findings recorded in the summary: Do not infer participants' CKD eligibility or renal-function results from a CKD mention in background literature. Record level: A stored summary within the scope of historical extraction/access; this is not new verification of original clinical materials in the current work. Independent replication: Distinguish actual report roles/families from access attempts, and do not count the 23 entries as 23 clinical trials. | Material | Public availability | Access status | Actually read | Notes | |---|---|---|---|---| | NCT structured registry body | Unverified (no external lookup in the current work) | Access not attempted | Not read | Distinguish historical success/failure from current nonattempted access and reading of retained stored summaries | ### S18 ClinicalTrials.gov NCT01473914 — Trace Element Replenishment in Hemodialysis [Source](https://clinicaltrials.gov/study/NCT01473914) Materials actually read: The designated retained stored summaries were actually read. External/old separate originals have not been read in the current work. Findings recorded in the summary: This is a multinutrient formulation lead; efficacy is not attributed to single-ingredient thiamine. Record level: A stored summary within the scope of historical extraction/access; this is not new verification of original clinical materials in the current work. Independent replication: Distinguish actual report roles/families from access attempts, and do not count the 23 entries as 23 clinical trials. | Material | Public availability | Access status | Actually read | Notes | |---|---|---|---|---| | NCT registry index | Unverified (no external lookup in the current work) | Access not attempted | Not read | Distinguish historical success/failure from current nonattempted access and reading of retained stored summaries | ### S19 Thiamine status in end-stage chronic kidney disease patients — PMID 30182293 [Source](https://europepmc.org/article/med/30182293) Materials actually read: The designated retained stored summaries were actually read. External/old separate originals have not been read in the current work. Findings recorded in the summary: Observational nutritional-status data are not a causal renal-function effect of oral treatment. Record level: A stored summary within the scope of historical extraction/access; this is not new verification of original clinical materials in the current work. Independent replication: Distinguish actual report roles/families from access attempts, and do not count the 23 entries as 23 clinical trials. | Material | Public availability | Access status | Actually read | Notes | |---|---|---|---|---| | Article bibliography/index | Unverified (no external lookup in the current work) | Access not attempted | Not read | Distinguish historical success/failure from current nonattempted access and reading of retained stored summaries | ### S20 Li et al. Associations between early thiamine administration and clinical outcomes in critically ill patients with acute kidney injury [Source](https://www.cambridge.org/core/journals/british-journal-of-nutrition/article/associations-between-early-thiamine-administration-and-clinical-outcomes-in-critically-ill-patients-with-acute-kidney-injury/C178876656FB314C6EBECC46D7FEFE76) Materials actually read: The designated retained stored summaries were actually read. External/old separate originals have not been read in the current work. Findings recorded in the summary: Critically ill patients with acute kidney injury are not recast as a chronic CKD oral single-ingredient trial. Record level: A stored summary within the scope of historical extraction/access; this is not new verification of original clinical materials in the current work. Independent replication: Distinguish actual report roles/families from access attempts, and do not count the 23 entries as 23 clinical trials. | Material | Public availability | Access status | Actually read | Notes | |---|---|---|---|---| | Original article abstract | Unverified (no external lookup in the current work) | Access not attempted | Not read | Distinguish historical success/failure from current nonattempted access and reading of retained stored summaries | ### S21 Bukhari et al. thiamine transporter expression in experimental chronic kidney disease [Source](https://pmc.ncbi.nlm.nih.gov/articles/PMC3164444/) Materials actually read: The designated retained stored summaries were actually read. External/old separate originals have not been read in the current work. Findings recorded in the summary: This is animal/mechanistic research, not counted as evidence of renal-function efficacy in humans. Record level: A stored summary within the scope of historical extraction/access; this is not new verification of original clinical materials in the current work. Independent replication: Distinguish actual report roles/families from access attempts, and do not count the 23 entries as 23 clinical trials. | Material | Public availability | Access status | Actually read | Notes | |---|---|---|---|---| | Animal-study bibliography/index | Unverified (no external lookup in the current work) | Access not attempted | Not read | Distinguish historical success/failure from current nonattempted access and reading of retained stored summaries | ### S22 Khon Kaen University research publication catalogue — 2025 [Source](https://medres.kku.ac.th/mdpaper/dbresearch/show_pub_num_db3_2/18/2025) Materials actually read: The designated retained stored summaries were actually read. External/old separate originals have not been read in the current work. Findings recorded in the summary: This is for bibliographic verification, not material that verifies route, salt or detailed results. Record level: A stored summary within the scope of historical extraction/access; this is not new verification of original clinical materials in the current work. Independent replication: Distinguish actual report roles/families from access attempts, and do not count the 23 entries as 23 clinical trials. | Material | Public availability | Access status | Actually read | Notes | |---|---|---|---|---| | Institutional bibliography page | Unverified (no external lookup in the current work) | Access not attempted | Not read | Distinguish historical success/failure from current nonattempted access and reading of retained stored summaries | ### S23 PubMed native query access attempt [Source](https://pubmed.ncbi.nlm.nih.gov/?term=thiamine+chronic+kidney+disease+randomized) Materials actually read: The designated retained stored summaries were actually read. External/old separate originals have not been read in the current work. Findings recorded in the summary: This is not represented as a completed PubMed database search. Record level: A stored summary within the scope of historical extraction/access; this is not new verification of original clinical materials in the current work. Independent replication: Distinguish actual report roles/families from access attempts, and do not count the 23 entries as 23 clinical trials. | Material | Public availability | Access status | Actually read | Notes | |---|---|---|---|---| | PubMed search result set | Unverified (no external lookup in the current work) | Access not attempted | Not read | Distinguish historical success/failure from current nonattempted access and reading of retained stored summaries | ## Review criteria and methods These are Chamgap's own application conditions, informed by the relevant sections of official methodological guidance. They do not constitute official assessment-tool certification or a new efficacy score. - M03 [Cochrane Handbook 6.5 (2024), chapter updated 2023-08](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03) · §3.1, §3.2.1–3.2.3, MECIR C5/C7/C13 · Clearly record the question, eligibility criteria and reasons for changes, and distinguish variations in the intervention. · From 1585, reuse of the retained methodological principles/versions and actual HTML5 copies. This is not new reading of the full methodological texts or formal implementation/certification in the current work. - M04 [Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04) · §4.5, §4.6.1–4.6.3, MECIR C42 · Distinguish and link studies and reports, and do not omit a study solely because its outcomes are not reported. · From 1585, reuse of the retained methodological principles/versions and actual HTML5 copies. This is not new reading of the full methodological texts or formal implementation/certification in the current work. - M08 [Cochrane Handbook 6.5 (2024), chapter updated 2019-10](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08) · §8.1–8.2.3, Table 8.2.a · Hold the outcome and effect of interest fixed, then assess randomization, deviations, missing data, measurement and selective reporting. · From 1585, reuse of the retained methodological principles/versions and actual HTML5 copies. This is not new reading of the full methodological texts or formal implementation/certification in the current work. - M15 [Cochrane Handbook 6.5 (2024), chapter updated 2023-08](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15) · §15.2.4, §15.3.1–15.3.3 · Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision. · From 1585, reuse of the retained methodological principles/versions and actual HTML5 copies. This is not new reading of the full methodological texts or formal implementation/certification in the current work. - M19 [Cochrane Handbook 6.5 (2024), chapter updated 2019-10](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19) · §19.1.2, §19.2.1–19.2.4 · Questions about harms may require designs, populations and follow-up different from efficacy questions. Case reports do not establish incidence. · From 1585, reuse of the retained methodological principles/versions and actual HTML5 copies. This is not new reading of the full methodological texts or formal implementation/certification in the current work. ## What the statuses mean - Partly verified: Some records are available, but gaps remain in actual exposure, population/comparator, denominators/intervals and original-source access. - Unverified: The necessary information/conditions cannot be established within the scope checked in the current work. - Review incomplete: Comparison/search of original materials was not performed within the authorized scope. - Not reported: A scope-limited status indicating that the item was not stated in the specific material/section read. - Inaccessible: Used only for materials where access was actually attempted and failed. Not assigned to clinical materials in the current work. - Insufficient eligible evidence: Used only when relevant studies within a defined scope have been reviewed and the evidence is insufficient to answer the conditions. Not applied exhaustively in the current work. - Not applicable: A specific exception under the applicability conditions. Not a substitute status for material that has not been read. - Conflicting information: An unresolved difference in dosage-form descriptions within the same trial. Differences in results from different analyses/measures are not automatically called conflicts. - Met: Verification of the specified preservation/distinction/linking conditions. This is not certification of clinical efficacy, reading of external full texts or individual safety. - Does not apply: A material/extension boundary that does not apply to the direct conditions of the current locked question. Direct evidence is required for the corresponding separate claim. ## Change history 2026-11-07 · Public page/materials 1.0. Public-facing display and data were created from the existing 39 items. No new clinical search, change in verification status or scoring was performed. ## Material-specific source addresses - S01-M1 · Original article PDF/HTML: Material URL unverified; external material unread. - S02-M1 · Publisher abstract, bibliography and graphical abstract: Material URL unverified; external material unread. - S03-M1 · Critical letter HTML/PDF: Material URL unverified; external material unread. - S04-M1 · Reply preview/repository bibliography: Material URL unverified; external material unread. - S05-M1 · Article index/abstract: Material URL unverified; external material unread. - S06-M1 · Article abstract/registry index: Material URL unverified; external material unread. - S07-M1 · Article index excerpts: Material URL unverified; external material unread. - S08-M1 · Repository search index: Material URL unverified; external material unread. - S09-M1 · Original article abstract: Material URL unverified; external material unread. - S10-M1 · Original article abstract/author's full-text copy: Material URL unverified; external material unread. - S11-M1 · PubMed article abstract: Material URL unverified; external material unread. - S12-M1 · Review HTML: Material URL unverified; external material unread. - S13-M1 · Authorized-product SmPC HTML: Material URL unverified; external material unread. - S14-M1 · Official nutrition fact sheet HTML: Material URL unverified; external material unread. - S15-M1 · CTRI lookup screen/actual registry record: Material URL unverified; external material unread. - S16-M1 · Thai registry homepage/search results: Material URL unverified; external material unread. - S17-M1 · NCT structured registry body: Material URL unverified; external material unread. - S18-M1 · NCT registry index: Material URL unverified; external material unread. - S19-M1 · Article bibliography/index: Material URL unverified; external material unread. - S20-M1 · Original article abstract: Material URL unverified; external material unread. - S21-M1 · Animal-study bibliography/index: Material URL unverified; external material unread. - S22-M1 · Institutional bibliography page: Material URL unverified; external material unread. - S23-M1 · PubMed search result set: Material URL unverified; external material unread.