{ "schema_version": "chamgap-public-evidence-check-1.0", "public_id": "v3121-main", "verdict_number": "3121", "title": "Ordinary thiamine (vitamin B1); actual salt not reported × Three-month Cockcroft–Gault-derived renal-function readout in early diabetic nephropathy", "view_version": "1.0", "view_created_date": "2026-11-07", "criteria_version": "3121-ORAL-THIAMINE-CG-3M-1.0", "criteria_date": "2026-10-04", "review_date": "2026-10-04", "legacy_evidence_date": "2026-09-16", "review_scope": { "materials_read": "Stored Korean and English manuscripts and case-specific criteria and application records", "clinical_papers_directly_read": false, "new_clinical_search": false, "limitation": "Reading stored summaries is distinguished from not reading external source materials or historical separate documents, while preserving the original verdict, numerical values and unverified information. No new clinical search, source reading, effect calculation or reassessment was performed.", "date_meaning": "This is the date the stored materials were checked, not the date of an up-to-date clinical literature search." }, "claim_context": { "population": "Age 35–65 years, type 2 diabetes and persistent microalbuminuria; CKD stage and uniform deficiency status unverified", "intervention": "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", "endpoint": "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", "excluded_extensions": "Urinary albumin, annual slope/long-term events, CKD overall, other derivatives/combinations/dialysis, and observational/acute/animal data are not combined as direct effects." }, "requirements": [ { "item_id": "N01", "question_type": "Independent claim", "question": "Which thiamine renal-function question is being presented in a single table?", "needed": "The current manuscript's boundaries for population, single active ingredient, oral route, placebo/usual care, and CG end mean at 3 months", "role": "Required (selected renal-function question)", "role_reason": "Required to avoid combining renal-function values, urinary albumin, long-term progression and other preparations into a single efficacy status.", "application_exception": "Do not remove the unspecified CKD stage and unreported salt to present an apparently precise identity.", "criterion": "Retain the same independent question as the original /ko/effect and the actual PICO/time point, and explain the excluded questions.", "basis": "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.", "condition_origin": "Development criteria individually written after actually reading the already known case 3121. This is not blinding, preregistration or independent clinical certification.", "proposed_research": "Extract direct comparative results within this boundary, and keep eGFR slope and kidney-failure events as separate questions.", "current_reports": [ "S01" ], "existence": "Stored bibliographic/extracted records and historical access records currently exist. This is not a new external check of current existence or corrections.", "acquired_read": "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.", "observation": "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.", "condition_status": "Met", "status_reason": "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.", "missingness": "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.", "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.", "review_date": "2026-10-04", "reading_status": "Original source not read · Stored summary read", "additional_material": "The current manuscript's boundaries for population, single active ingredient, oral route, placebo/usual care, and CG end mean at 3 months" }, { "item_id": "N02", "question_type": "Molecule and salt", "question": "Have the actual salt and equivalent amount of single-ingredient ordinary thiamine been verified?", "needed": "Trial product ingredient list, salt, purity, manufacturer, excipients and free-thiamine equivalent", "role": "Required (selected renal-function question)", "role_reason": "Required to avoid treating ordinary thiamine, hydrochloride, nitrate, benfotiamine and a separate authorized product as the same exposure.", "application_exception": "Preserve the record of a single active ingredient, but do not fill in hydrochloride for the unreported salt.", "criterion": "Record the original trial's single active ingredient separately from the unverified chemical form/product identity.", "basis": "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.", "condition_origin": "Development criteria individually written after actually reading the already known case 3121. This is not blinding, preregistration or independent clinical certification.", "proposed_research": "Verify identity against the original product and manufacturing/ingredient records, and review other salts and derivatives separately.", "current_reports": [ "S01", "S09", "S13" ], "existence": "Stored bibliographic/extracted records and historical access records currently exist. This is not a new external check of current existence or corrections.", "acquired_read": "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.", "observation": "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.", "condition_status": "Partly verified", "status_reason": "The single-active-ingredient boundary is recorded, but the actual chemical form and product identity cannot be established from the retained materials.", "missingness": "The single-active-ingredient boundary is recorded, but the actual chemical form and product identity cannot be established from the retained materials.", "uncertainty": "The single-active-ingredient boundary is recorded, but the actual chemical form and product identity cannot be established from the retained materials.", "review_date": "2026-10-04", "reading_status": "Original source not read · Stored summary read", "additional_material": "Trial product ingredient list, salt, purity, manufacturer, excipients and free-thiamine equivalent" }, { "item_id": "N03", "question_type": "Physical dosage form", "question": "Has the difference between the capsule and tablet descriptions in the original article been resolved?", "needed": "Exact dosage-form wording in the S01 abstract and methods, and product/batch verification materials", "role": "Required (selected renal-function question)", "role_reason": "Required to avoid silently harmonizing different dosage-form descriptions within the same original article.", "application_exception": "Do not infer a different trial or a difference in effects from the capsule/tablet discrepancy.", "criterion": "Preserve both descriptions and retain the conflict until verified against evidence about the actual product.", "basis": "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.", "condition_origin": "Development criteria individually written after actually reading the already known case 3121. This is not blinding, preregistration or independent clinical certification.", "proposed_research": "Compare the original article's dosage-form descriptions with product records to clarify the physical dosage form in the same trial.", "current_reports": [ "S01" ], "existence": "Stored bibliographic/extracted records and historical access records currently exist. This is not a new external check of current existence or corrections.", "acquired_read": "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.", "observation": "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.", "condition_status": "Conflicting information", "status_reason": "Evidence about the actual product that would resolve the capsule/tablet discrepancy in the same trial has not yet been linked.", "missingness": "Evidence about the actual product that would resolve the capsule/tablet discrepancy in the same trial has not yet been linked.", "uncertainty": "Evidence about the actual product that would resolve the capsule/tablet discrepancy in the same trial has not yet been linked.", "review_date": "2026-10-04", "reading_status": "Original source not read · Stored summary read", "additional_material": "Exact dosage-form wording in the S01 abstract and methods, and product/batch verification materials" }, { "item_id": "N04", "question_type": "Nominal and actual dose", "question": "Have the nominal dose and the actual dosing schedule and adherence been distinguished?", "needed": "Nominal 3×100 mg/day; actual administration/intake records; meal timing; adherence rate; active-ingredient equivalent", "role": "Required (selected renal-function question)", "role_reason": "Required to avoid automatically converting a nominal total amount into actual exposure or a schedule of 3 times a day.", "application_exception": "The retained 300 mg/day is an existing record, not a value calculated in the current work or a suggested dose for self-administration.", "criterion": "Preserve the original nominal amount, and indicate gaps in the actual divided-dose schedule, meals, adherence and equivalence conversion.", "basis": "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.", "condition_origin": "Development criteria individually written after actually reading the already known case 3121. This is not blinding, preregistration or independent clinical certification.", "proposed_research": "Link the original intake and adherence records to product identity to extract actual exposure.", "current_reports": [ "S01" ], "existence": "Stored bibliographic/extracted records and historical access records currently exist. This is not a new external check of current existence or corrections.", "acquired_read": "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.", "observation": "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.", "condition_status": "Partly verified", "status_reason": "The nominal amount is recorded, but materials needed to establish actual exposure, schedule and adherence remain outstanding.", "missingness": "The nominal amount is recorded, but materials needed to establish actual exposure, schedule and adherence remain outstanding.", "uncertainty": "The nominal amount is recorded, but materials needed to establish actual exposure, schedule and adherence remain outstanding.", "review_date": "2026-10-04", "reading_status": "Original source not read · Stored summary read", "additional_material": "Nominal 3×100 mg/day; actual administration/intake records; meal timing; adherence rate; active-ingredient equivalent" }, { "item_id": "N05", "question_type": "Treatment and observation duration", "question": "Have 3 months of treatment and 2 months of observation after discontinuation been separated?", "needed": "Results at the main time point of 3 months; treatment duration; original endpoint-specific results during the additional 2 months of observation after discontinuation", "role": "Required (selected renal-function question)", "role_reason": "Required to avoid turning end-of-treatment results into a sustained effect over 5 months or an annual slope.", "application_exception": "Do not establish a sustained effect solely from the existence of additional observation.", "criterion": "Record the main time point/treatment and additional observation after discontinuation separately, and retain the scope for which direct results on maintenance are unavailable.", "basis": "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.", "condition_origin": "Development criteria individually written after actually reading the already known case 3121. This is not blinding, preregistration or independent clinical certification.", "proposed_research": "Extract actual renal-function results at each visit and post-discontinuation time point separately to retain the time boundaries.", "current_reports": [ "S01" ], "existence": "Stored bibliographic/extracted records and historical access records currently exist. This is not a new external check of current existence or corrections.", "acquired_read": "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.", "observation": "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.", "condition_status": "Partly verified", "status_reason": "The distinction between periods has been verified, but specific results addressing maintenance of renal function after discontinuation are separate from the current target result.", "missingness": "The distinction between periods has been verified, but specific results addressing maintenance of renal function after discontinuation are separate from the current target result.", "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.", "review_date": "2026-10-04", "reading_status": "Original source not read · Stored summary read", "additional_material": "Results at the main time point of 3 months; treatment duration; original endpoint-specific results during the additional 2 months of observation after discontinuation" }, { "item_id": "N06", "question_type": "Actual population", "question": "Have the actual participants' diabetes, microalbuminuria and CKD stage been verified?", "needed": "Eligibility criteria for age 35–65 years, type 2 diabetes and persistent microalbuminuria; baseline renal function; CKD stage", "role": "Required (selected renal-function question)", "role_reason": "Required to avoid extending early diabetic nephropathy to CKD of all causes/stages or to dialysis/transplantation.", "application_exception": "Do not replace the currently unspecified CKD stage with an arbitrary stage 1/2/3.", "criterion": "Retain the verified age/disease/albuminuria together with the unverified stage, and indicate population differences.", "basis": "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.", "condition_origin": "Development criteria individually written after actually reading the already known case 3121. This is not blinding, preregistration or independent clinical certification.", "proposed_research": "Compare original eligibility criteria, baseline distributions and stage data, and review direct comparisons by stage/cause separately.", "current_reports": [ "S01" ], "existence": "Stored bibliographic/extracted records and historical access records currently exist. This is not a new external check of current existence or corrections.", "acquired_read": "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.", "observation": "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.", "condition_status": "Partly verified", "status_reason": "Age, disease and albuminuria are recorded, but stage and applicability to all CKD cannot be established.", "missingness": "Age, disease and albuminuria are recorded, but stage and applicability to all CKD cannot be established.", "uncertainty": "Age, disease and albuminuria are recorded, but stage and applicability to all CKD cannot be established.", "review_date": "2026-10-04", "reading_status": "Original source not read · Stored summary read", "additional_material": "Eligibility criteria for age 35–65 years, type 2 diabetes and persistent microalbuminuria; baseline renal function; CKD stage" }, { "item_id": "N07", "question_type": "Nutritional status", "question": "Can correction of deficiency be distinguished from additional supplementation in nondeficient participants?", "needed": "Baseline plasma/dietary thiamine status; definition of deficiency; eligibility/analysis exclusions; renal-function results by status", "role": "Required (selected renal-function question)", "role_reason": "Required to avoid harmonizing low plasma levels and indicators of dietary adequacy into a single deficient/nondeficient population.", "application_exception": "Do not confuse the analysis exclusion of 1 participant with high thiamine levels with uniform deficiency status across the whole population.", "criterion": "Distinguish verified status indicators from unverified uniform deficiency and separately attributable effects.", "basis": "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.", "condition_origin": "Development criteria individually written after actually reading the already known case 3121. This is not blinding, preregistration or independent clinical certification.", "proposed_research": "Link nutritional-status definitions and analyses by status to actual renal-function denominators.", "current_reports": [ "S01" ], "existence": "Stored bibliographic/extracted records and historical access records currently exist. This is not a new external check of current existence or corrections.", "acquired_read": "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.", "observation": "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.", "condition_status": "Partly verified", "status_reason": "Materials needed to distinguish uniform deficiency status in the population and the effects of deficiency correction versus additional supplementation in nondeficient participants remain outstanding.", "missingness": "Materials needed to distinguish uniform deficiency status in the population and the effects of deficiency correction versus additional supplementation in nondeficient participants remain outstanding.", "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.", "review_date": "2026-10-04", "reading_status": "Original source not read · Stored summary read", "additional_material": "Baseline plasma/dietary thiamine status; definition of deficiency; eligibility/analysis exclusions; renal-function results by status" }, { "item_id": "N08", "question_type": "Comparator and background treatment", "question": "Has the actual balance of placebo and usual treatment been verified?", "needed": "Placebo identity; diabetes/blood-pressure treatment by arm; insulin; changes/rescue treatment; analytical adjustment", "role": "Required (selected renal-function question)", "role_reason": "Required to avoid attributing differences in background treatment to thiamine's contribution.", "application_exception": "Compare the actual effect of interest and analysis without requiring every change in both arms to be identical.", "criterion": "Distinguish placebo/usual care from actual imbalances and unverified changes/adjustments.", "basis": "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.", "condition_origin": "Development criteria individually written after actually reading the already known case 3121. This is not blinding, preregistration or independent clinical certification.", "proposed_research": "Compare baseline/follow-up differences in concomitant treatment and their impact on analysis against the original materials.", "current_reports": [ "S01", "S03" ], "existence": "Stored bibliographic/extracted records and historical access records currently exist. This is not a new external check of current existence or corrections.", "acquired_read": "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.", "observation": "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.", "condition_status": "Partly verified", "status_reason": "The direction of comparison and concomitant-treatment imbalance are recorded, but adjustment/change data separating the causal contribution are insufficient.", "missingness": "The direction of comparison and concomitant-treatment imbalance are recorded, but adjustment/change data separating the causal contribution are insufficient.", "uncertainty": "The direction of comparison and concomitant-treatment imbalance are recorded, but adjustment/change data separating the causal contribution are insufficient.", "review_date": "2026-10-04", "reading_status": "Original source not read · Stored summary read", "additional_material": "Placebo identity; diabetes/blood-pressure treatment by arm; insulin; changes/rescue treatment; analytical adjustment" }, { "item_id": "N09", "question_type": "Allocation and concealment", "question": "At what level were randomization and concealment procedures reported?", "needed": "Actual procedures for the random-number table, central allocation and opaque envelopes; baseline balance; implementation records", "role": "Required (selected renal-function question)", "role_reason": "Required to avoid claiming that allocation/concealment has been verified solely from the randomized-trial label.", "application_exception": "Distinguish reported procedures from an independent audit of implementation, and do not call the pilot trial a formal confirmatory trial.", "criterion": "Link the level of allocation/concealment recorded in the original source to unverified implementation and baseline limitations.", "basis": "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.", "condition_origin": "Development criteria individually written after actually reading the already known case 3121. This is not blinding, preregistration or independent clinical certification.", "proposed_research": "Compare allocation, concealment and baseline-characteristic data for the outcome of interest.", "current_reports": [ "S01" ], "existence": "Stored bibliographic/extracted records and historical access records currently exist. This is not a new external check of current existence or corrections.", "acquired_read": "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.", "observation": "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.", "condition_status": "Partly verified", "status_reason": "The reporting of procedures has been verified, but independent verification of actual implementation and the adequacy of baseline data/analysis are separate matters.", "missingness": "The reporting of procedures has been verified, but independent verification of actual implementation and the adequacy of baseline data/analysis are separate matters.", "uncertainty": "The reporting of procedures has been verified, but independent verification of actual implementation and the adequacy of baseline data/analysis are separate matters.", "review_date": "2026-10-04", "reading_status": "Original source not read · Stored summary read", "additional_material": "Actual procedures for the random-number table, central allocation and opaque envelopes; baseline balance; implementation records" }, { "item_id": "N10", "question_type": "Blinding and adherence", "question": "Have reported blinding and actual adherence/blinding success been distinguished?", "needed": "Blinding of participants, care providers and assessors; actual adherence rate; blinding success; deviations by arm", "role": "Required (selected renal-function question)", "role_reason": "Required to avoid turning the double-blind label into actual balance of exposure or absence of bias.", "application_exception": "Do not remove post-allocation deviations or changes in measurement/treatment on the grounds that the formula-derived value is objective.", "criterion": "Record whose blinding was reported separately from gaps concerning success/adherence.", "basis": "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.", "condition_origin": "Development criteria individually written after actually reading the already known case 3121. This is not blinding, preregistration or independent clinical certification.", "proposed_research": "Link data on actual blinding, adherence and changes by arm to the original analysis.", "current_reports": [ "S01" ], "existence": "Stored bibliographic/extracted records and historical access records currently exist. This is not a new external check of current existence or corrections.", "acquired_read": "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.", "observation": "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.", "condition_status": "Partly verified", "status_reason": "Reported blinding and actual success/adherence have different levels of verification.", "missingness": "Reported blinding and actual success/adherence have different levels of verification.", "uncertainty": "Reported blinding and actual success/adherence have different levels of verification.", "review_date": "2026-10-04", "reading_status": "Original source not read · Stored summary read", "additional_material": "Blinding of participants, care providers and assessors; actual adherence rate; blinding success; deviations by arm" }, { "item_id": "N11", "question_type": "Renal-function measure", "question": "Have the formula, units and measurement boundaries of the value labeled GFR been verified?", "needed": "Original table notes on Cockcroft–Gault and creatinine/Jaffé; units; body-surface-area adjustment; measurement/assessment procedures", "role": "Required (selected renal-function question)", "role_reason": "Required to avoid turning a formula-derived value into measured GFR, body-surface-area-adjusted eGFR or an annual slope.", "application_exception": "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.", "criterion": "Distinguish the formula, units and labeling from unverified measurement procedures/errors.", "basis": "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.", "condition_origin": "Development criteria individually written after actually reading the already known case 3121. This is not blinding, preregistration or independent clinical certification.", "proposed_research": "Check the table notes and original measurement/calculation procedures to extract results by the same measure and units.", "current_reports": [ "S01" ], "existence": "Stored bibliographic/extracted records and historical access records currently exist. This is not a new external check of current existence or corrections.", "acquired_read": "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.", "observation": "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.", "condition_status": "Partly verified", "status_reason": "The measure/unit boundaries are recorded, but the original measurement and arm-specific procedures were not directly verified in the current work.", "missingness": "The measure/unit boundaries are recorded, but the original measurement and arm-specific procedures were not directly verified in the current work.", "uncertainty": "The measure/unit boundaries are recorded, but the original measurement and arm-specific procedures were not directly verified in the current work.", "review_date": "2026-10-04", "reading_status": "Original source not read · Stored summary read", "additional_material": "Original table notes on Cockcroft–Gault and creatinine/Jaffé; units; body-surface-area adjustment; measurement/assessment procedures" }, { "item_id": "N12", "question_type": "Endpoint hierarchy", "question": "Have the page's target and the original trial's primary endpoint been distinguished?", "needed": "The original trial's urinary-albumin primary endpoint; role of the GFR result; endpoint hierarchy in the registry/plan", "role": "Required (selected renal-function question)", "role_reason": "Required to avoid automatically transferring a reduction in urinary albumin to improved renal function or inhibition of long-term progression.", "application_exception": "GFR being this page's target does not mean it was preregistered as the trial's primary endpoint.", "criterion": "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.", "basis": "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.", "condition_origin": "Development criteria individually written after actually reading the already known case 3121. This is not blinding, preregistration or independent clinical certification.", "proposed_research": "Compare the registry and plan with the reported endpoint hierarchy, keeping urinary-albumin and renal-function results separate.", "current_reports": [ "S01" ], "existence": "Stored bibliographic/extracted records and historical access records currently exist. This is not a new external check of current existence or corrections.", "acquired_read": "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.", "observation": "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.", "condition_status": "Met", "status_reason": "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.", "missingness": "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.", "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.", "review_date": "2026-10-04", "reading_status": "Original source not read · Stored summary read", "additional_material": "The original trial's urinary-albumin primary endpoint; role of the GFR result; endpoint hierarchy in the registry/plan" }, { "item_id": "N13", "question_type": "Means and dispersion in the original table", "question": "Have the baseline and 3-month end means±SD been retained unchanged?", "needed": "S01 Table1: baseline/end means and SD by arm, units, time points and exact analyzed denominators", "role": "Required (selected renal-function question)", "role_reason": "Required to avoid turning arm-specific baseline/end values and SD into change SD or causal-effect intervals.", "application_exception": "Do not fill in analyzed denominators from the 20/20 allocation or newly calculate the difference between the two time points.", "criterion": "Assign the original retained arm-specific means/SD to the correct time points/units, leaving gaps in analyzed denominators.", "basis": "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.", "condition_origin": "Development criteria individually written after actually reading the already known case 3121. This is not blinding, preregistration or independent clinical certification.", "proposed_research": "Extract the original table together with the analyzed denominator at each time point and the definition of dispersion.", "current_reports": [ "S01" ], "existence": "Stored bibliographic/extracted records and historical access records currently exist. This is not a new external check of current existence or corrections.", "acquired_read": "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.", "observation": "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.", "condition_status": "Met", "status_reason": "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.", "missingness": "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.", "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.", "review_date": "2026-10-04", "reading_status": "Original source not read · Stored summary read", "additional_material": "S01 Table1: baseline/end means and SD by arm, units, time points and exact analyzed denominators" }, { "item_id": "N14", "question_type": "Descriptive difference and causal effect", "question": "Have the historical end-mean difference and the adjusted effect been distinguished?", "needed": "Originally reported between-group estimate; baseline-adjusted model; effect of interest; analysis population; interval", "role": "Required (selected renal-function question)", "role_reason": "Required to avoid interpreting a simple difference in end means with baseline differences as thiamine's causal effect or harm.", "application_exception": "−7 is existing descriptive arithmetic in the manuscript, not a value calculated, estimated or prescribed in the current work.", "criterion": "Record the historical unadjusted end-mean difference separately from the unverified adjusted causal effect/interval.", "basis": "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.", "condition_origin": "Development criteria individually written after actually reading the already known case 3121. This is not blinding, preregistration or independent clinical certification.", "proposed_research": "Compare effect magnitude only when the original adjusted model, between-group estimate and analyzed denominators have been obtained.", "current_reports": [ "S01" ], "existence": "Stored bibliographic/extracted records and historical access records currently exist. This is not a new external check of current existence or corrections.", "acquired_read": "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.", "observation": "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.", "condition_status": "Partly verified", "status_reason": "The descriptive difference has a defined boundary, but the original estimate/model needed to answer the causal between-group magnitude is unavailable.", "missingness": "The descriptive difference has a defined boundary, but the original estimate/model needed to answer the causal between-group magnitude is unavailable.", "uncertainty": "The descriptive difference has a defined boundary, but the original estimate/model needed to answer the causal between-group magnitude is unavailable.", "review_date": "2026-10-04", "reading_status": "Original source not read · Stored summary read", "additional_material": "Originally reported between-group estimate; baseline-adjusted model; effect of interest; analysis population; interval" }, { "item_id": "N15", "question_type": "Randomized and analyzed denominators", "question": "Have the 20/20 allocation and actual GFR analyzed/completer denominators been distinguished?", "needed": "Numbers randomized, completing and analyzed for GFR by arm; the arm and scope of applicability of the 1-person exclusion", "role": "Required (selected renal-function question)", "role_reason": "Required to avoid automatically using the 40 randomized participants as 40 analyzed participants or as 20/20 outcome denominators.", "application_exception": "From the existing record of 1 participant excluded from analysis, do not infer that an arm had 19 participants.", "criterion": "Distinguish allocation from analysis/completion, and preserve unverified denominators as null.", "basis": "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.", "condition_origin": "Development criteria individually written after actually reading the already known case 3121. This is not blinding, preregistration or independent clinical certification.", "proposed_research": "Compare the original flow diagram and analysis exclusions with the arm-specific denominators in the GFR table.", "current_reports": [ "S01" ], "existence": "Stored bibliographic/extracted records and historical access records currently exist. This is not a new external check of current existence or corrections.", "acquired_read": "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.", "observation": "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.", "condition_status": "Unverified", "status_reason": "The actual arm-specific analyzed/completer denominators for the selected GFR result cannot be established.", "missingness": "The actual arm-specific analyzed/completer denominators for the selected GFR result cannot be established.", "uncertainty": "The actual arm-specific analyzed/completer denominators for the selected GFR result cannot be established.", "review_date": "2026-10-04", "reading_status": "Original source not read · Stored summary read", "additional_material": "Numbers randomized, completing and analyzed for GFR by arm; the arm and scope of applicability of the 1-person exclusion" }, { "item_id": "N16", "question_type": "Missing data and analysis populations", "question": "Have GFR missing data, analysis populations and change variance been verified?", "needed": "ITT/PP; handling of attrition/missing data; outcome-specific application of exclusions; paired-change SD/correlation", "role": "Required (selected renal-function question)", "role_reason": "Required to avoid reconstructing missing-data handling or change CI from known marginal SD and randomized numbers.", "application_exception": "Do not label the analysis population ITT without the original source.", "criterion": "Retain the reported exclusion and unverified analysis/missing data and paired variance, without creating new estimates.", "basis": "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.", "condition_origin": "Development criteria individually written after actually reading the already known case 3121. This is not blinding, preregistration or independent clinical certification.", "proposed_research": "Link the original analysis population, missing-data/sensitivity handling and change variance to the outcome of interest.", "current_reports": [ "S01" ], "existence": "Stored bibliographic/extracted records and historical access records currently exist. This is not a new external check of current existence or corrections.", "acquired_read": "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.", "observation": "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.", "condition_status": "Unverified", "status_reason": "Missing-data handling, analysis populations and change variance are unavailable, so the effect/interval cannot be reconstructed.", "missingness": "Missing-data handling, analysis populations and change variance are unavailable, so the effect/interval cannot be reconstructed.", "uncertainty": "Missing-data handling, analysis populations and change variance are unavailable, so the effect/interval cannot be reconstructed.", "review_date": "2026-10-04", "reading_status": "Original source not read · Stored summary read", "additional_material": "ITT/PP; handling of attrition/missing data; outcome-specific application of exclusions; paired-change SD/correlation" }, { "item_id": "N17", "question_type": "Precision and importance", "question": "Have the exact P, CI and clinical importance been verified?", "needed": "Original GFR between-group estimate/exact P and CI; justified important difference; denominators/model", "role": "Required (selected renal-function question)", "role_reason": "Required to avoid concluding an effect of 0, exclusion of clinical benefit or equivalence from the word nonsignificant alone.", "application_exception": "Do not propose arbitrary numbers for sample size, duration or the minimum important difference.", "criterion": "Link the original intervals/importance criteria, or indicate why interpretation is not possible.", "basis": "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.", "condition_origin": "Development criteria individually written after actually reading the already known case 3121. This is not blinding, preregistration or independent clinical certification.", "proposed_research": "Obtain the original estimate, CI, exact P and endpoint-specific basis for importance to review the scope of interpretation.", "current_reports": [ "S01" ], "existence": "Stored bibliographic/extracted records and historical access records currently exist. This is not a new external check of current existence or corrections.", "acquired_read": "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.", "observation": "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.", "condition_status": "Unverified", "status_reason": "The original estimates/intervals/criteria needed to interpret precision and importance remain unverified.", "missingness": "The original estimates/intervals/criteria needed to interpret precision and importance remain unverified.", "uncertainty": "The original estimates/intervals/criteria needed to interpret precision and importance remain unverified.", "review_date": "2026-10-04", "reading_status": "Original source not read · Stored summary read", "additional_material": "Original GFR between-group estimate/exact P and CI; justified important difference; denominators/model" }, { "item_id": "N18", "question_type": "Interpretation of nonsignificance", "question": "Has a nonsignificant result been kept from being recast as an effect of 0 or equivalence?", "needed": "Original report of nonsignificant renal-function results; unverified estimates/CI; separate evidence for equivalence/exclusion of benefit", "role": "Required (selected renal-function question)", "role_reason": "Required to avoid strengthening verified nonsignificant results into definitive favorable or unfavorable conclusions.", "application_exception": "Retain the record of nonsignificance, but do not use it to assign a new efficacy/safety grade.", "criterion": "Preserve the reported direction together with uncertainty, distinguishing them from a true effect of 0, equivalence or exclusion of benefit.", "basis": "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.", "condition_origin": "Development criteria individually written after actually reading the already known case 3121. This is not blinding, preregistration or independent clinical certification.", "proposed_research": "Review the original nonsignificant results together with intervals/denominators, avoiding an inaccurate interpretation as an effect of 0.", "current_reports": [ "S01" ], "existence": "Stored bibliographic/extracted records and historical access records currently exist. This is not a new external check of current existence or corrections.", "acquired_read": "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.", "observation": "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.", "condition_status": "Met", "status_reason": "The distinction between nonsignificance and uncertainty agrees with the retained original text. This is not a finding that efficacy criteria are met.", "missingness": "The distinction between nonsignificance and uncertainty agrees with the retained original text. This is not a finding that efficacy criteria are met.", "uncertainty": "The distinction between nonsignificance and uncertainty agrees with the retained original text. This is not a finding that efficacy criteria are met.", "review_date": "2026-10-04", "reading_status": "Original source not read · Stored summary read", "additional_material": "Original report of nonsignificant renal-function results; unverified estimates/CI; separate evidence for equivalence/exclusion of benefit" }, { "item_id": "N19", "question_type": "Trial families and overlap", "question": "Have reports, mirrors and companion reports been kept from being summed as independent trials?", "needed": "TF01–TF08 families; original articles/mirrors; correspondence/companion reports; links for overlapping denominators/results", "role": "Required (selected renal-function question)", "role_reason": "Required to avoid counting publisher/PubMed/author mirrors and companion analyses as independent replications/participants.", "application_exception": "Do not turn unverified participant overlap in companion reports into confirmation of either the same cohort or a different trial.", "criterion": "Distinguish verified families from provisional links, and preserve only their contributions to the direct locked result.", "basis": "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.", "condition_origin": "Development criteria individually written after actually reading the already known case 3121. This is not blinding, preregistration or independent clinical certification.", "proposed_research": "Compare family/registry/report/result/participant relationships to separate independent comparisons from potential overlaps.", "current_reports": [ "S01", "S03", "S04", "S05", "S06", "S07", "S08" ], "existence": "Stored bibliographic/extracted records and historical access records currently exist. This is not a new external check of current existence or corrections.", "acquired_read": "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.", "observation": "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.", "condition_status": "Partly verified", "status_reason": "Direct families and mirrors are distinguished, but exact cohort links for companion reports remain unverified.", "missingness": "Direct families and mirrors are distinguished, but exact cohort links for companion reports remain unverified.", "uncertainty": "Direct families and mirrors are distinguished, but exact cohort links for companion reports remain unverified.", "review_date": "2026-10-04", "reading_status": "Original source not read · Stored summary read", "additional_material": "TF01–TF08 families; original articles/mirrors; correspondence/companion reports; links for overlapping denominators/results" }, { "item_id": "N20", "question_type": "Critical letter and reply", "question": "Have the substantive content of the critical letter and the unread reply been distinguished?", "needed": "S03 critique/endpoint interpretation; S04 full reply; distinction between correspondence and corrections/retractions", "role": "Required (selected renal-function question)", "role_reason": "Required to avoid claiming that the authors' substantive reply was read or turning correspondence into a new trial/correction.", "application_exception": "Do not automatically transfer the issue concerning urinary-albumin medians to an error in the GFR result.", "criterion": "Keep the scope of the verified critique separate from that of the unread reply.", "basis": "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.", "condition_origin": "Development criteria individually written after actually reading the already known case 3121. This is not blinding, preregistration or independent clinical certification.", "proposed_research": "Compare the full reply with the points in the original critique by endpoint, checking actual correction events separately.", "current_reports": [ "S03", "S04" ], "existence": "Stored bibliographic/extracted records and historical access records currently exist. This is not a new external check of current existence or corrections.", "acquired_read": "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.", "observation": "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.", "condition_status": "Partly verified", "status_reason": "The role of the critique has been verified, but the actual arguments in the reply remain unverified.", "missingness": "The role of the critique has been verified, but the actual arguments in the reply remain unverified.", "uncertainty": "The role of the critique has been verified, but the actual arguments in the reply remain unverified.", "review_date": "2026-10-04", "reading_status": "Original source not read · Stored summary read", "additional_material": "S03 critique/endpoint interpretation; S04 full reply; distinction between correspondence and corrections/retractions" }, { "item_id": "N21", "question_type": "Companion reports and cohorts", "question": "Have the same participants and additional results in S05–S08 been verified?", "needed": "Registration, recruitment, populations and denominators; participant/result links between reports", "role": "Required (selected renal-function question)", "role_reason": "Required to avoid adding companion analyses as new participants or direct replications.", "application_exception": "Do not establish that all of the same 40 participants were included solely from a shared registry lead.", "criterion": "Separate verified links from unverified participant-level overlap.", "basis": "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.", "condition_origin": "Development criteria individually written after actually reading the already known case 3121. This is not blinding, preregistration or independent clinical certification.", "proposed_research": "Compare full companion reports, recruitment/registration and denominators to verify cohort links.", "current_reports": [ "S05", "S06", "S07", "S08" ], "existence": "Stored bibliographic/extracted records and historical access records currently exist. This is not a new external check of current existence or corrections.", "acquired_read": "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.", "observation": "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.", "condition_status": "Unverified", "status_reason": "Full texts, participant-level links and additional contributions to the direct CG result remain unverified.", "missingness": "Full texts, participant-level links and additional contributions to the direct CG result remain unverified.", "uncertainty": "Full texts, participant-level links and additional contributions to the direct CG result remain unverified.", "review_date": "2026-10-04", "reading_status": "Original source not read · Stored summary read", "additional_material": "Registration, recruitment, populations and denominators; participant/result links between reports" }, { "item_id": "N22", "question_type": "Registration and plans", "question": "Have a printed registration number and actual reading of the registry/plan been distinguished?", "needed": "CTRI2008/091/000112 actual registry record, dates, original protocol/SAP and outcome hierarchy", "role": "Required (selected renal-function question)", "role_reason": "Required to avoid turning a printed number into comparison with the entire registry record or verification of the prespecified hierarchy.", "application_exception": "Do not use an access barrier as evidence of nonregistration.", "criterion": "Record the reported number, actual failure/nonreading and gaps in the prespecified hierarchy.", "basis": "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.", "condition_origin": "Development criteria individually written after actually reading the already known case 3121. This is not blinding, preregistration or independent clinical certification.", "proposed_research": "In an authorized update, link the actual registry/plan and change history to the outcome hierarchy.", "current_reports": [ "S01", "S15" ], "existence": "Stored bibliographic/extracted records and historical access records currently exist. This is not a new external check of current existence or corrections.", "acquired_read": "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.", "observation": "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.", "condition_status": "Unverified", "status_reason": "Beyond the number, the actual original registry and plan contents remain unread/unverified.", "missingness": "Beyond the number, the actual original registry and plan contents remain unread/unverified.", "uncertainty": "Beyond the number, the actual original registry and plan contents remain unread/unverified.", "review_date": "2026-10-04", "reading_status": "Original source not read · Stored summary read", "additional_material": "CTRI2008/091/000112 actual registry record, dates, original protocol/SAP and outcome hierarchy" }, { "item_id": "N23", "question_type": "Funding and independence", "question": "Have the levels of verification of public funding and conflict-of-interest declarations been distinguished?", "needed": "Reported funding; product provision/involvement; author relationships; scope of independent verification", "role": "Supplementary; required for claims of independence", "role_reason": "Required to avoid turning reported declarations into an independent audit of implementation or replication.", "application_exception": "Do not automatically exclude results or establish absence of bias solely from funding.", "criterion": "Retain reported declarations together with gaps in product involvement/independent verification.", "basis": "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.", "condition_origin": "Development criteria individually written after actually reading the already known case 3121. This is not blinding, preregistration or independent clinical certification.", "proposed_research": "Compare original funding, product provision and relationships, and review independent replication separately.", "current_reports": [ "S01" ], "existence": "Stored bibliographic/extracted records and historical access records currently exist. This is not a new external check of current existence or corrections.", "acquired_read": "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.", "observation": "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.", "condition_status": "Partly verified", "status_reason": "Reported funding/declarations are available, but product involvement and independent verification remain unverified.", "missingness": "Reported funding/declarations are available, but product involvement and independent verification remain unverified.", "uncertainty": "Reported funding/declarations are available, but product involvement and independent verification remain unverified.", "review_date": "2026-10-04", "reading_status": "Original source not read · Stored summary read", "additional_material": "Reported funding; product provision/involvement; author relationships; scope of independent verification" }, { "item_id": "N24", "question_type": "Adjacent CKD3 results", "question": "What do the different stage, duration and eGFR change in S02 answer?", "needed": "S02 actual population, exposure/salt, definition of change over 24 weeks, analyzed denominators and original estimate/CI", "role": "Supplementary (adjacent comparison)", "role_reason": "Required to avoid transferring results with a different measure and duration into direct replication of the 3-month CG result.", "application_exception": "Do not fill in analyzed denominators from the randomization of 35 participants, 18/17.", "criterion": "Indicate the scope of the adjacent abstract and the unverified exposure/denominators and precision.", "basis": "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.", "condition_origin": "Development criteria individually written after actually reading the already known case 3121. This is not blinding, preregistration or independent clinical certification.", "proposed_research": "Verify actual exposure, change, denominators/intervals in the adjacent full text and review them as a separate question.", "current_reports": [ "S02" ], "existence": "Stored bibliographic/extracted records and historical access records currently exist. This is not a new external check of current existence or corrections.", "acquired_read": "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.", "observation": "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.", "condition_status": "Partly verified", "status_reason": "Adjacent numerical results are available, but actual exposure/denominators, precision and direct comparability remain unverified.", "missingness": "Adjacent numerical results are available, but actual exposure/denominators, precision and direct comparability remain unverified.", "uncertainty": "Adjacent numerical results are available, but actual exposure/denominators, precision and direct comparability remain unverified.", "review_date": "2026-10-04", "reading_status": "Original source not read · Stored summary read", "additional_material": "S02 actual population, exposure/salt, definition of change over 24 weeks, analyzed denominators and original estimate/CI" }, { "item_id": "N25", "question_type": "Bibliography and adjacent families", "question": "Have S02 and S22 been kept from being counted as different trials?", "needed": "Online/print dates, DOI/institutional bibliography and links to the same TF02 report", "role": "Required (selected renal-function question)", "role_reason": "Required to avoid adding an institutional bibliographic entry as an independent replication.", "application_exception": "Do not arbitrarily harmonize the 2025 online and 2026 print publication years into a single year.", "criterion": "Distinguish the bibliography of the same TF02 report and its different measure/duration relative to the locked question.", "basis": "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.", "condition_origin": "Development criteria individually written after actually reading the already known case 3121. This is not blinding, preregistration or independent clinical certification.", "proposed_research": "Retain links to the same DOI/report, and verify any new independent comparison separately.", "current_reports": [ "S02", "S22" ], "existence": "Stored bibliographic/extracted records and historical access records currently exist. This is not a new external check of current existence or corrections.", "acquired_read": "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.", "observation": "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.", "condition_status": "Met", "status_reason": "This verifies bibliographic/family and measure boundaries, not the adjacent effect.", "missingness": "This verifies bibliographic/family and measure boundaries, not the adjacent effect.", "uncertainty": "This verifies bibliographic/family and measure boundaries, not the adjacent effect.", "review_date": "2026-10-04", "reading_status": "Original source not read · Stored summary read", "additional_material": "Online/print dates, DOI/institutional bibliography and links to the same TF02 report" }, { "item_id": "N26", "question_type": "Provenance of the review estimate", "question": "Has the relationship between the review's 0.31 estimate and the original end means been verified?", "needed": "S12 estimand, denominators, additional-data/change definitions and links to original results", "role": "Required (selected renal-function question)", "role_reason": "Required to avoid removing the possibility of a different analysis and automatically declaring an error or the same effect.", "application_exception": "Do not declare a review error or conflicting information solely from the current difference.", "criterion": "Retain the unverified link between the review's MD/CI and the original end means.", "basis": "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.", "condition_origin": "Development criteria individually written after actually reading the already known case 3121. This is not blinding, preregistration or independent clinical certification.", "proposed_research": "Compare the review's extraction table, estimand and additional data with the original results.", "current_reports": [ "S01", "S12" ], "existence": "Stored bibliographic/extracted records and historical access records currently exist. This is not a new external check of current existence or corrections.", "acquired_read": "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.", "observation": "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.", "condition_status": "Unverified", "status_reason": "The actual analysis/data provenance of the review estimate remains unverified.", "missingness": "The actual analysis/data provenance of the review estimate remains unverified.", "uncertainty": "The actual analysis/data provenance of the review estimate remains unverified.", "review_date": "2026-10-04", "reading_status": "Original source not read · Stored summary read", "additional_material": "S12 estimand, denominators, additional-data/change definitions and links to original results" }, { "item_id": "N27", "question_type": "Other derivatives", "question": "Has benfotiamine been transferred into a direct effect of ordinary thiamine?", "needed": "Distinctions between molecule/exposure, endpoints and trial families", "role": "Supplementary (boundary for other derivatives)", "role_reason": "Required to avoid attributing results and safety for other derivatives to ordinary thiamine.", "application_exception": "Retain the historical access limitations for S09.", "criterion": "Exclude the different derivative TF03 from the locked direct comparison.", "basis": "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.", "condition_origin": "Development criteria individually written after actually reading the already known case 3121. This is not blinding, preregistration or independent clinical certification.", "proposed_research": "Check the relevant original materials when separately reviewing a question about the derivative.", "current_reports": [ "S09" ], "existence": "Stored bibliographic/extracted records and historical access records currently exist. This is not a new external check of current existence or corrections.", "acquired_read": "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.", "observation": "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.", "condition_status": "Does not apply", "status_reason": "Because it is a different molecule, it does not meet the conditions of the locked direct comparison.", "missingness": "Because it is a different molecule, it does not meet the conditions of the locked direct comparison.", "uncertainty": "Because it is a different molecule, it does not meet the conditions of the locked direct comparison.", "review_date": "2026-10-04", "reading_status": "Original source not read · Stored summary read", "additional_material": "Distinctions between molecule/exposure, endpoints and trial families" }, { "item_id": "N28", "question_type": "Combination and dialysis data", "question": "Has the individual contribution been verified from combination products or multinutrient registry records?", "needed": "Combination ingredients; dialysis population; cognition/other endpoints; distinction between registry records and results", "role": "Supplementary (combination/dialysis boundary)", "role_reason": "Required to avoid turning combination results into the renal-function contribution of single-ingredient ordinary thiamine.", "application_exception": "Do not label a registry index record as completed results.", "criterion": "Separate S10 combination cognition data and the S18 multinutrient registry record from the locked direct comparison.", "basis": "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.", "condition_origin": "Development criteria individually written after actually reading the already known case 3121. This is not blinding, preregistration or independent clinical certification.", "proposed_research": "For combination/dialysis questions, separately review the results and whether the individual contribution can be identified.", "current_reports": [ "S10", "S18" ], "existence": "Stored bibliographic/extracted records and historical access records currently exist. This is not a new external check of current existence or corrections.", "acquired_read": "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.", "observation": "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.", "condition_status": "Does not apply", "status_reason": "The combination, dialysis and endpoint/registry boundaries differ, so these do not apply to the direct locked comparison.", "missingness": "The combination, dialysis and endpoint/registry boundaries differ, so these do not apply to the direct locked comparison.", "uncertainty": "The combination, dialysis and endpoint/registry boundaries differ, so these do not apply to the direct locked comparison.", "review_date": "2026-10-04", "reading_status": "Original source not read · Stored summary read", "additional_material": "Combination ingredients; dialysis population; cognition/other endpoints; distinction between registry records and results" }, { "item_id": "N29", "question_type": "Observational, acute and animal data", "question": "Have status associations, acute AKI and animal data been transferred into chronic oral effects?", "needed": "Distinctions between population/design, exposure, endpoints and data roles", "role": "Supplementary (data boundary)", "role_reason": "Required to avoid calling observational/acute/animal data a causal effect of chronic oral treatment in humans.", "application_exception": "Do not expand the scope of index/abstract reading into full-text review.", "criterion": "Retain the design and population differences in S19–S21.", "basis": "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.", "condition_origin": "Development criteria individually written after actually reading the already known case 3121. This is not blinding, preregistration or independent clinical certification.", "proposed_research": "For each separate question, verify eligible direct materials and the scope actually read.", "current_reports": [ "S19", "S20", "S21" ], "existence": "Stored bibliographic/extracted records and historical access records currently exist. This is not a new external check of current existence or corrections.", "acquired_read": "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.", "observation": "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.", "condition_status": "Does not apply", "status_reason": "The designs and populations/exposures differ, so these do not apply to the locked direct comparison.", "missingness": "The designs and populations/exposures differ, so these do not apply to the locked direct comparison.", "uncertainty": "The designs and populations/exposures differ, so these do not apply to the locked direct comparison.", "review_date": "2026-10-04", "reading_status": "Original source not read · Stored summary read", "additional_material": "Distinctions between population/design, exposure, endpoints and data roles" }, { "item_id": "N30", "question_type": "Renal pharmacokinetics", "question": "Do single-dose 100 mg data in ESRD answer chronic 300 mg safety?", "needed": "S11 actual molecule, single dose/24 hours and ESRD; distinction between concentration/excretion and chronic harms", "role": "Supplementary; required for safety claims concerning repeated exposure", "role_reason": "Required to avoid turning pharmacokinetic exposure into chronic efficacy or prescribing by kidney-disease stage.", "application_exception": "Do not harmonize single-dose nitrate/benfotiamine with the trial's 300 mg regimen whose salt was not reported.", "criterion": "Separate the reported single-dose conditions from gaps concerning chronic harms/dose.", "basis": "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.", "condition_origin": "Development criteria individually written after actually reading the already known case 3121. This is not blinding, preregistration or independent clinical certification.", "proposed_research": "Separately verify pharmacokinetic/harm data for the same molecule, stage and repeated exposure.", "current_reports": [ "S11" ], "existence": "Stored bibliographic/extracted records and historical access records currently exist. This is not a new external check of current existence or corrections.", "acquired_read": "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.", "observation": "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.", "condition_status": "Partly verified", "status_reason": "Adjacent single-dose data are available, but the actual connection to chronic exposure/harms remains unverified.", "missingness": "Adjacent single-dose data are available, but the actual connection to chronic exposure/harms remains unverified.", "uncertainty": "Adjacent single-dose data are available, but the actual connection to chronic exposure/harms remains unverified.", "review_date": "2026-10-04", "reading_status": "Original source not read · Stored summary read", "additional_material": "S11 actual molecule, single dose/24 hours and ESRD; distinction between concentration/excretion and chronic harms" }, { "item_id": "N31", "question_type": "Separate authorized product", "question": "Has the identity of the S13 SmPC product and the trial product been established as the same?", "needed": "Authorized product identity, version, ingredients/warnings and whether it is the same as the trial product", "role": "Supplementary (product/safety context)", "role_reason": "Required to avoid substituting a separate regulated product for the unreported trial product.", "application_exception": "Do not turn an authorized product's doses/warnings into an individual CKD prescription.", "criterion": "Separate historical verification of the separate product from the unverified trial product.", "basis": "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.", "condition_origin": "Development criteria individually written after actually reading the already known case 3121. This is not blinding, preregistration or independent clinical certification.", "proposed_research": "Verify the relationship between the actual trial product and the authorized product, and the version/warnings.", "current_reports": [ "S01", "S13" ], "existence": "Stored bibliographic/extracted records and historical access records currently exist. This is not a new external check of current existence or corrections.", "acquired_read": "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.", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "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.", "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.", "review_date": "2026-10-04", "reading_status": "Original source not read · Stored summary read", "additional_material": "Authorized product identity, version, ingredients/warnings and whether it is the same as the trial product" }, { "item_id": "N32", "question_type": "Official nutrition information and interactions", "question": "Does the absence of an established UL mean unlimited safety?", "needed": "Insufficient data in the official explanation; medication/exposure context; version; harms in the actual population", "role": "Supplementary; required for safety claims", "role_reason": "Required to avoid turning the absence of an established UL into high-dose CKD safety or unrestricted intake.", "application_exception": "Do not use general explanations as direct CKD trials or prescribing guidance.", "criterion": "Retain insufficient data and medication wording together with gaps in quantitative harms.", "basis": "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.", "condition_origin": "Development criteria individually written after actually reading the already known case 3121. This is not blinding, preregistration or independent clinical certification.", "proposed_research": "Compare official explanations separately with harms for the actual exposure/population concerned.", "current_reports": [ "S14" ], "existence": "Stored bibliographic/extracted records and historical access records currently exist. This is not a new external check of current existence or corrections.", "acquired_read": "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.", "observation": "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.", "condition_status": "Partly verified", "status_reason": "Official context is available, but quantitative harms/interactions for the same exposure in CKD remain unverified.", "missingness": "Official context is available, but quantitative harms/interactions for the same exposure in CKD remain unverified.", "uncertainty": "Official context is available, but quantitative harms/interactions for the same exposure in CKD remain unverified.", "review_date": "2026-10-04", "reading_status": "Original source not read · Stored summary read", "additional_material": "Insufficient data in the official explanation; medication/exposure context; version; harms in the actual population" }, { "item_id": "N33", "question_type": "Harms and event denominators", "question": "Have denominators for adverse reactions, serious events and discontinuations been verified?", "needed": "Arm-specific AE/SAE for the same exposure; collection/duration; exposure denominators; reasons for discontinuation", "role": "Supplementary; required for safety claims", "role_reason": "Required to avoid turning unverified quantitative harms into 0 events/0 risk.", "application_exception": "Do not transfer reactions to injectable products into oral incidence rates.", "criterion": "Retain unverified events/denominators and duration for the original harms data.", "basis": "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.", "condition_origin": "Development criteria individually written after actually reading the already known case 3121. This is not blinding, preregistration or independent clinical certification.", "proposed_research": "Verify arm-specific harm collection, denominators/duration and discontinuations for the same oral regimen.", "current_reports": [ "S01", "S11", "S13", "S14" ], "existence": "Stored bibliographic/extracted records and historical access records currently exist. This is not a new external check of current existence or corrections.", "acquired_read": "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.", "observation": "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.", "condition_status": "Unverified", "status_reason": "Arm-specific harm events, exposure and collection/discontinuation data remain unverified.", "missingness": "Arm-specific harm events, exposure and collection/discontinuation data remain unverified.", "uncertainty": "Arm-specific harm events, exposure and collection/discontinuation data remain unverified.", "review_date": "2026-10-04", "reading_status": "Original source not read · Stored summary read", "additional_material": "Arm-specific AE/SAE for the same exposure; collection/duration; exposure denominators; reasons for discontinuation" }, { "item_id": "N34", "question_type": "Long-term and stage-specific safety", "question": "Have long-term accumulation and doses for special populations/by stage been verified?", "needed": "Actual data on repeated/long-term exposure, accumulation, doses by kidney-disease stage and vulnerable populations/concomitant use", "role": "Supplementary; required for those extension claims", "role_reason": "Required to avoid extending a short-term pilot trial into long-term/stage-specific prescribing.", "application_exception": "Do not require all extension studies as prerequisites for the narrow question about the mean at 3 months.", "criterion": "Indicate the scope for which direct long-term/special-population data are unavailable.", "basis": "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.", "condition_origin": "Development criteria individually written after actually reading the already known case 3121. This is not blinding, preregistration or independent clinical certification.", "proposed_research": "For extension questions, review harms and direct dose comparisons for the same molecule, stage and repeated exposure.", "current_reports": [ "S01", "S11", "S13", "S14" ], "existence": "Stored bibliographic/extracted records and historical access records currently exist. This is not a new external check of current existence or corrections.", "acquired_read": "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.", "observation": "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.", "condition_status": "Unverified", "status_reason": "Long-term and stage-specific repeated-exposure/dose and special-population results remain unverified.", "missingness": "Long-term and stage-specific repeated-exposure/dose and special-population results remain unverified.", "uncertainty": "Long-term and stage-specific repeated-exposure/dose and special-population results remain unverified.", "review_date": "2026-10-04", "reading_status": "Original source not read · Stored summary read", "additional_material": "Actual data on repeated/long-term exposure, accumulation, doses by kidney-disease stage and vulnerable populations/concomitant use" }, { "item_id": "N35", "question_type": "Long-term progression and events", "question": "Does the 3-month CG readout answer questions about annual slope or kidney-failure events?", "needed": "Direct endpoints of annual slope, dialysis/kidney failure/death in the same population/exposure", "role": "Supplementary; required for claims about long-term events", "role_reason": "Required to avoid turning a surrogate renal-function readout and urinary albumin into patient-centered inhibition of progression.", "application_exception": "Distinguish the status of the current narrow numerical question from that of the long-term-event question.", "criterion": "Do not claim annual slope and long-term events as direct locked results.", "basis": "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.", "condition_origin": "Development criteria individually written after actually reading the already known case 3121. This is not blinding, preregistration or independent clinical certification.", "proposed_research": "For a long-term-progression question, review direct endpoints and adequate follow-up/denominators separately.", "current_reports": [ "S01", "S02" ], "existence": "Stored bibliographic/extracted records and historical access records currently exist. This is not a new external check of current existence or corrections.", "acquired_read": "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.", "observation": "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.", "condition_status": "Does not apply", "status_reason": "This does not apply to the conditions of the currently selected readout, and direct data are needed for long-term-event claims.", "missingness": "This does not apply to the conditions of the currently selected readout, and direct data are needed for long-term-event claims.", "uncertainty": "This does not apply to the conditions of the currently selected readout, and direct data are needed for long-term-event claims.", "review_date": "2026-10-04", "reading_status": "Original source not read · Stored summary read", "additional_material": "Direct endpoints of annual slope, dialysis/kidney failure/death in the same population/exposure" }, { "item_id": "N36", "question_type": "Unacquired registry lead", "question": "Has the actual body of NCT06322212 been read?", "needed": "Actual structured registry body; eligibility/exposure; results/status; original change history", "role": "Required (selected renal-function question)", "role_reason": "Required to avoid calling a JavaScript shell and CKD background descriptions actual participants/results.", "application_exception": "Do not automatically promote a registry lead to an eligible direct comparison or completed results.", "criterion": "Distinguish the unacquired body and failed access from background/eligibility criteria.", "basis": "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.", "condition_origin": "Development criteria individually written after actually reading the already known case 3121. This is not blinding, preregistration or independent clinical certification.", "proposed_research": "In an authorized update, verify the actual registry body and results/changes to reconsider the boundaries.", "current_reports": [ "S17" ], "existence": "Stored bibliographic/extracted records and historical access records currently exist. This is not a new external check of current existence or corrections.", "acquired_read": "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.", "observation": "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.", "condition_status": "Unverified", "status_reason": "The actual registry body, eligibility/exposure and results remain unverified.", "missingness": "The actual registry body, eligibility/exposure and results remain unverified.", "uncertainty": "The actual registry body, eligibility/exposure and results remain unverified.", "review_date": "2026-10-04", "reading_status": "Original source not read · Stored summary read", "additional_material": "Actual structured registry body; eligibility/exposure; results/status; original change history" }, { "item_id": "N37", "question_type": "Search and correction scope", "question": "Have search attempts been distinguished from completed native-database/correction reviews?", "needed": "Cutoff date; search routes/results; actual scope of negative/unpublished results, registry records and corrections/retractions", "role": "Required (selected renal-function question)", "role_reason": "Required to avoid turning search errors, homepages and existing routes into exhaustive searches or current correction reviews.", "application_exception": "No new search in the current work does not mean 0 studies or no recent corrections.", "criterion": "Distinguish the historical 41 general-web searches from incomplete native lookups and the current local conversion.", "basis": "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.", "condition_origin": "Development criteria individually written after actually reading the already known case 3121. This is not blinding, preregistration or independent clinical certification.", "proposed_research": "In a separately authorized update, record actual search/registry/correction results and the scope of failures.", "current_reports": [ "S15", "S16", "S23" ], "existence": "Stored bibliographic/extracted records and historical access records currently exist. This is not a new external check of current existence or corrections.", "acquired_read": "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.", "observation": "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.", "condition_status": "Partly verified", "status_reason": "Current exhaustive checks, checks of unpublished results/corrections and incomplete native searches remain outstanding.", "missingness": "Current exhaustive checks, checks of unpublished results/corrections and incomplete native searches remain outstanding.", "uncertainty": "Current exhaustive checks, checks of unpublished results/corrections and incomplete native searches remain outstanding.", "review_date": "2026-10-04", "reading_status": "Original source not read · Stored summary read", "additional_material": "Cutoff date; search routes/results; actual scope of negative/unpublished results, registry records and corrections/retractions" }, { "item_id": "N38", "question_type": "Original verdict and document quality", "question": "Are the existing D30 and document A being read as new clinical verification?", "needed": "Original grade/score; document assessment; verification actor; actual scope of conversion", "role": "Required (selected renal-function question)", "role_reason": "Required to separate document self-checking from clinical/safety certification.", "application_exception": "Do not use the current table's statuses/counts as a new efficacy score.", "criterion": "Preserve the original D30/Caution and document/self-checking records as historical values.", "basis": "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.", "condition_origin": "Development criteria individually written after actually reading the already known case 3121. This is not blinding, preregistration or independent clinical certification.", "proposed_research": "If a new evidence event is authorized, link a separate version/decision to the clinical evidence.", "current_reports": [ "S01" ], "existence": "Stored bibliographic/extracted records and historical access records currently exist. This is not a new external check of current existence or corrections.", "acquired_read": "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.", "observation": "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.", "condition_status": "Met", "status_reason": "This verifies the distinction between original values and document roles, not a new clinical verdict.", "missingness": "This verifies the distinction between original values and document roles, not a new clinical verdict.", "uncertainty": "This verifies the distinction between original values and document roles, not a new clinical verdict.", "review_date": "2026-10-04", "reading_status": "Original source not read · Stored summary read", "additional_material": "Original grade/score; document assessment; verification actor; actual scope of conversion" }, { "item_id": "N39", "question_type": "Reading, identity and updates", "question": "Are summary links and past publication metadata being read as verification of current original sources/publication?", "needed": "ID/URL; dates/revisions; historical/current reading by material; exact pointer/literal/SHA; update links", "role": "Required (selected renal-function question)", "role_reason": "Required to distinguish reading retained stored summaries from external clinical originals/public publication in the current work.", "application_exception": "Do not use a local stored-summary SHA as the hash of an external PDF's original bytes.", "criterion": "Link to the exact stored summary, and indicate current nonreading of external materials and local nonpublication.", "basis": "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.", "condition_origin": "Development criteria individually written after actually reading the already known case 3121. This is not blinding, preregistration or independent clinical certification.", "proposed_research": "When new materials arrive, preserve everything before changes and reconsider the relevant rows, materials, criteria version and change decision.", "current_reports": [ "S01", "S02", "S03", "S04", "S11", "S12", "S13", "S14" ], "existence": "Stored bibliographic/extracted records and historical access records currently exist. This is not a new external check of current existence or corrections.", "acquired_read": "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.", "observation": "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.", "condition_status": "Met", "status_reason": "This verifies preservation/linking conditions. External original bytes, current versions and new corrections/publication remain unverified.", "missingness": "This verifies preservation/linking conditions. External original bytes, current versions and new corrections/publication remain unverified.", "uncertainty": "This verifies preservation/linking conditions. External original bytes, current versions and new corrections/publication remain unverified.", "review_date": "2026-10-04", "reading_status": "Original source not read · Stored summary read", "additional_material": "ID/URL; dates/revisions; historical/current reading by material; exact pointer/literal/SHA; update links" } ], "reports": [ { "report_id": "S01", "title": "Rabbani et al. High-dose thiamine therapy for patients with type 2 diabetes and microalbuminuria: a randomised, double-blind placebo-controlled pilot study", "url": "https://link.springer.com/content/pdf/10.1007/s00125-008-1224-4.pdf", "report_type": "Direct pilot RCT · Historical full text/PDF, 5 pages", "existence": "Stored bibliography/historical access attempts. No external lookup of current existence or corrections/retractions was performed in the current work.", "acquired_read": "The designated retained stored summaries were actually read. External/old separate originals have not been read in the current work.", "study_family": "TF01", "independent_replication": "Distinguish actual report roles/families from access attempts, and do not count the 23 entries as 23 clinical trials.", "observed_result": "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.", "result_level": "A stored summary within the scope of historical extraction/access; this is not new verification of original clinical materials in the current work.", "source_evidence_date": "2026-09-16", "materials": [ { "material_type": "Original article PDF/HTML", "public_status": "Unverified (no external lookup in the current work)", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-04", "qualification": "Distinguish historical success/failure from current nonattempted access and reading of retained stored summaries", "material_id": "S01-M1", "url": null, "parent_url": "https://link.springer.com/content/pdf/10.1007/s00125-008-1224-4.pdf" } ], "links": [ { "label": "Source", "url": "https://link.springer.com/content/pdf/10.1007/s00125-008-1224-4.pdf" } ] }, { "report_id": "S02", "title": "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", "url": "https://www.benthamscience.com/article/148808", "report_type": "Adjacent CKD3 RCT · Historical publisher abstract/metadata/graphical abstract", "existence": "Stored bibliography/historical access attempts. No external lookup of current existence or corrections/retractions was performed in the current work.", "acquired_read": "The designated retained stored summaries were actually read. External/old separate originals have not been read in the current work.", "study_family": "TF02", "independent_replication": "Distinguish actual report roles/families from access attempts, and do not count the 23 entries as 23 clinical trials.", "observed_result": "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.", "result_level": "A stored summary within the scope of historical extraction/access; this is not new verification of original clinical materials in the current work.", "source_evidence_date": "2026-09-16", "materials": [ { "material_type": "Publisher abstract, bibliography and graphical abstract", "public_status": "Unverified (no external lookup in the current work)", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-04", "qualification": "Distinguish historical success/failure from current nonattempted access and reading of retained stored summaries", "material_id": "S02-M1", "url": null, "parent_url": "https://www.benthamscience.com/article/148808" } ], "links": [ { "label": "Source", "url": "https://www.benthamscience.com/article/148808" } ] }, { "report_id": "S03", "title": "Alkhalaf et al. Thiamine in diabetic nephropathy: a novel treatment modality?", "url": "https://link.springer.com/article/10.1007/s00125-009-1326-7", "report_type": "Critical letter · Historical HTML/PDF text", "existence": "Stored bibliography/historical access attempts. No external lookup of current existence or corrections/retractions was performed in the current work.", "acquired_read": "The designated retained stored summaries were actually read. External/old separate originals have not been read in the current work.", "study_family": "TF01", "independent_replication": "Distinguish actual report roles/families from access attempts, and do not count the 23 entries as 23 clinical trials.", "observed_result": "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.", "result_level": "A stored summary within the scope of historical extraction/access; this is not new verification of original clinical materials in the current work.", "source_evidence_date": "2026-09-16", "materials": [ { "material_type": "Critical letter HTML/PDF", "public_status": "Unverified (no external lookup in the current work)", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-04", "qualification": "Distinguish historical success/failure from current nonattempted access and reading of retained stored summaries", "material_id": "S03-M1", "url": null, "parent_url": "https://link.springer.com/article/10.1007/s00125-009-1326-7" } ], "links": [ { "label": "Source", "url": "https://link.springer.com/article/10.1007/s00125-009-1326-7" } ] }, { "report_id": "S04", "title": "Rabbani et al. Thiamine in diabetic nephropathy: a novel treatment modality? Reply to Alkhalaf A, Kleefstra N, Groenier KH et al.", "url": "https://link.springer.com/article/10.1007/s00125-009-1334-7", "report_type": "Authors' reply · Historical preview/bibliography", "existence": "Stored bibliography/historical access attempts. No external lookup of current existence or corrections/retractions was performed in the current work.", "acquired_read": "The designated retained stored summaries were actually read. External/old separate originals have not been read in the current work.", "study_family": "TF01", "independent_replication": "Distinguish actual report roles/families from access attempts, and do not count the 23 entries as 23 clinical trials.", "observed_result": "The full reply was not read. Do not state that the authors' substantive response to the critique was verified.", "result_level": "A stored summary within the scope of historical extraction/access; this is not new verification of original clinical materials in the current work.", "source_evidence_date": "2026-09-16", "materials": [ { "material_type": "Reply preview/repository bibliography", "public_status": "Unverified (no external lookup in the current work)", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-04", "qualification": "Distinguish historical success/failure from current nonattempted access and reading of retained stored summaries", "material_id": "S04-M1", "url": null, "parent_url": "https://link.springer.com/article/10.1007/s00125-009-1334-7" } ], "links": [ { "label": "Source", "url": "https://link.springer.com/article/10.1007/s00125-009-1334-7" } ] }, { "report_id": "S05", "title": "Alam et al. Effect of High Dose Thiamine Therapy on Risk Factors in Type 2 Diabetics", "url": "https://www.iomcworld.com/open-access/effect-of-high-dose-thiamine-therapy-on-risk-factors-in-type-2-diabetics-26626.html", "report_type": "Companion risk-factor report discovered · Historical index/abstract", "existence": "Stored bibliography/historical access attempts. No external lookup of current existence or corrections/retractions was performed in the current work.", "acquired_read": "The designated retained stored summaries were actually read. External/old separate originals have not been read in the current work.", "study_family": "TF01-linked_unresolved", "independent_replication": "Distinguish actual report roles/families from access attempts, and do not count the 23 entries as 23 clinical trials.", "observed_result": "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.", "result_level": "A stored summary within the scope of historical extraction/access; this is not new verification of original clinical materials in the current work.", "source_evidence_date": "2026-09-16", "materials": [ { "material_type": "Article index/abstract", "public_status": "Unverified (no external lookup in the current work)", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-04", "qualification": "Distinguish historical success/failure from current nonattempted access and reading of retained stored summaries", "material_id": "S05-M1", "url": null, "parent_url": "https://www.iomcworld.com/open-access/effect-of-high-dose-thiamine-therapy-on-risk-factors-in-type-2-diabetics-26626.html" } ], "links": [ { "label": "Source", "url": "https://www.iomcworld.com/open-access/effect-of-high-dose-thiamine-therapy-on-risk-factors-in-type-2-diabetics-26626.html" } ] }, { "report_id": "S06", "title": "Alam et al. Effect of high dose thiamine therapy on activity and molecular aspects of transketolase in Type 2 diabetic patients", "url": "https://www.researchgate.net/publication/228438546_Effect_of_high_dose_thiamine_therapy_on_activity_and_molecular_aspects_of_transketolase_in_Type_2_diabetic_patients", "report_type": "Companion enzyme report discovered · Historical abstract/registry index", "existence": "Stored bibliography/historical access attempts. No external lookup of current existence or corrections/retractions was performed in the current work.", "acquired_read": "The designated retained stored summaries were actually read. External/old separate originals have not been read in the current work.", "study_family": "TF01-linked_unresolved", "independent_replication": "Distinguish actual report roles/families from access attempts, and do not count the 23 entries as 23 clinical trials.", "observed_result": "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.", "result_level": "A stored summary within the scope of historical extraction/access; this is not new verification of original clinical materials in the current work.", "source_evidence_date": "2026-09-16", "materials": [ { "material_type": "Article abstract/registry index", "public_status": "Unverified (no external lookup in the current work)", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-04", "qualification": "Distinguish historical success/failure from current nonattempted access and reading of retained stored summaries", "material_id": "S06-M1", "url": null, "parent_url": "https://www.researchgate.net/publication/228438546_Effect_of_high_dose_thiamine_therapy_on_activity_and_molecular_aspects_of_transketolase_in_Type_2_diabetic_patients" } ], "links": [ { "label": "Source", "url": "https://www.researchgate.net/publication/228438546_Effect_of_high_dose_thiamine_therapy_on_activity_and_molecular_aspects_of_transketolase_in_Type_2_diabetic_patients" } ] }, { "report_id": "S07", "title": "Riaz et al. Effect of high dose thiamine on the levels of urinary protein biomarkers in diabetes mellitus type 2", "url": "https://www.ovid.com/journals/jpaba/fulltext/10.1016/j.jpba.2010.11.008~effect-of-high-dose-thiamine-on-the-levels-of-urinary", "report_type": "Companion protein-marker report discovered · Historical index", "existence": "Stored bibliography/historical access attempts. No external lookup of current existence or corrections/retractions was performed in the current work.", "acquired_read": "The designated retained stored summaries were actually read. External/old separate originals have not been read in the current work.", "study_family": "TF01-linked_unresolved", "independent_replication": "Distinguish actual report roles/families from access attempts, and do not count the 23 entries as 23 clinical trials.", "observed_result": "These are protein biomarkers, not the locked renal-function endpoint. Potential overlap prevents counting additional participants.", "result_level": "A stored summary within the scope of historical extraction/access; this is not new verification of original clinical materials in the current work.", "source_evidence_date": "2026-09-16", "materials": [ { "material_type": "Article index excerpts", "public_status": "Unverified (no external lookup in the current work)", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-04", "qualification": "Distinguish historical success/failure from current nonattempted access and reading of retained stored summaries", "material_id": "S07-M1", "url": null, "parent_url": "https://www.ovid.com/journals/jpaba/fulltext/10.1016/j.jpba.2010.11.008~effect-of-high-dose-thiamine-on-the-levels-of-urinary" } ], "links": [ { "label": "Source", "url": "https://www.ovid.com/journals/jpaba/fulltext/10.1016/j.jpba.2010.11.008~effect-of-high-dose-thiamine-on-the-levels-of-urinary" } ] }, { "report_id": "S08", "title": "Alam et al. thiamine / pyruvate dehydrogenase and alpha-ketoglutarate dehydrogenase report", "url": "https://hal.science/hal-05496736v1", "report_type": "Companion enzyme report discovered · Historical search index (record unread)", "existence": "Stored bibliography/historical access attempts. No external lookup of current existence or corrections/retractions was performed in the current work.", "acquired_read": "The designated retained stored summaries were actually read. External/old separate originals have not been read in the current work.", "study_family": "TF01-linked_unresolved", "independent_replication": "Distinguish actual report roles/families from access attempts, and do not count the 23 entries as 23 clinical trials.", "observed_result": "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.", "result_level": "A stored summary within the scope of historical extraction/access; this is not new verification of original clinical materials in the current work.", "source_evidence_date": "2026-09-16", "materials": [ { "material_type": "Repository search index", "public_status": "Unverified (no external lookup in the current work)", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-04", "qualification": "Distinguish historical success/failure from current nonattempted access and reading of retained stored summaries", "material_id": "S08-M1", "url": null, "parent_url": "https://hal.science/hal-05496736v1" } ], "links": [ { "label": "Source", "url": "https://hal.science/hal-05496736v1" } ] }, { "report_id": "S09", "title": "Alkhalaf et al. A Double-Blind, Randomized, Placebo-Controlled Clinical Trial on Benfotiamine Treatment in Patients With Diabetic Nephropathy", "url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC2890365/", "report_type": "RCT of a different derivative · Historical primary abstract", "existence": "Stored bibliography/historical access attempts. No external lookup of current existence or corrections/retractions was performed in the current work.", "acquired_read": "The designated retained stored summaries were actually read. External/old separate originals have not been read in the current work.", "study_family": "TF03", "independent_replication": "Distinguish actual report roles/families from access attempts, and do not count the 23 entries as 23 clinical trials.", "observed_result": "Benfotiamine is separate from ordinary thiamine. That trial's effects, denominators and safety are not imported into this page.", "result_level": "A stored summary within the scope of historical extraction/access; this is not new verification of original clinical materials in the current work.", "source_evidence_date": "2026-09-16", "materials": [ { "material_type": "Original article abstract", "public_status": "Unverified (no external lookup in the current work)", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-04", "qualification": "Distinguish historical success/failure from current nonattempted access and reading of retained stored summaries", "material_id": "S09-M1", "url": null, "parent_url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC2890365/" } ], "links": [ { "label": "Source", "url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC2890365/" } ] }, { "report_id": "S10", "title": "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", "url": "https://pubmed.ncbi.nlm.nih.gov/42059045/", "report_type": "Combination/dialysis cognition trial · Historical screening materials", "existence": "Stored bibliography/historical access attempts. No external lookup of current existence or corrections/retractions was performed in the current work.", "acquired_read": "The designated retained stored summaries were actually read. External/old separate originals have not been read in the current work.", "study_family": "TF04", "independent_replication": "Distinguish actual report roles/families from access attempts, and do not count the 23 entries as 23 clinical trials.", "observed_result": "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.", "result_level": "A stored summary within the scope of historical extraction/access; this is not new verification of original clinical materials in the current work.", "source_evidence_date": "2026-09-16", "materials": [ { "material_type": "Original article abstract/author's full-text copy", "public_status": "Unverified (no external lookup in the current work)", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-04", "qualification": "Distinguish historical success/failure from current nonattempted access and reading of retained stored summaries", "material_id": "S10-M1", "url": null, "parent_url": "https://pubmed.ncbi.nlm.nih.gov/42059045/" } ], "links": [ { "label": "Source", "url": "https://pubmed.ncbi.nlm.nih.gov/42059045/" } ] }, { "report_id": "S11", "title": "Frank et al. Alteration of thiamine pharmacokinetics by end-stage renal disease (ESRD)", "url": "https://pubmed.ncbi.nlm.nih.gov/10507244/", "report_type": "Single-dose ESRD pharmacokinetics · Historical abstract", "existence": "Stored bibliography/historical access attempts. No external lookup of current existence or corrections/retractions was performed in the current work.", "acquired_read": "The designated retained stored summaries were actually read. External/old separate originals have not been read in the current work.", "study_family": "TF05", "independent_replication": "Distinguish actual report roles/families from access attempts, and do not count the 23 entries as 23 clinical trials.", "observed_result": "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.", "result_level": "A stored summary within the scope of historical extraction/access; this is not new verification of original clinical materials in the current work.", "source_evidence_date": "2026-09-16", "materials": [ { "material_type": "PubMed article abstract", "public_status": "Unverified (no external lookup in the current work)", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-04", "qualification": "Distinguish historical success/failure from current nonattempted access and reading of retained stored summaries", "material_id": "S11-M1", "url": null, "parent_url": "https://pubmed.ncbi.nlm.nih.gov/10507244/" } ], "links": [ { "label": "Source", "url": "https://pubmed.ncbi.nlm.nih.gov/10507244/" } ] }, { "report_id": "S12", "title": "Raval et al. Vitamin B and its derivatives for diabetic kidney disease", "url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC11252721/", "report_type": "Review · Historical HTML (discovery/estimate provenance unresolved)", "existence": "Stored bibliography/historical access attempts. No external lookup of current existence or corrections/retractions was performed in the current work.", "acquired_read": "The designated retained stored summaries were actually read. External/old separate originals have not been read in the current work.", "study_family": null, "independent_replication": "Distinguish actual report roles/families from access attempts, and do not count the 23 entries as 23 clinical trials.", "observed_result": "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.", "result_level": "A stored summary within the scope of historical extraction/access; this is not new verification of original clinical materials in the current work.", "source_evidence_date": "2026-09-16", "materials": [ { "material_type": "Review HTML", "public_status": "Unverified (no external lookup in the current work)", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-04", "qualification": "Distinguish historical success/failure from current nonattempted access and reading of retained stored summaries", "material_id": "S12-M1", "url": null, "parent_url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC11252721/" } ], "links": [ { "label": "Source", "url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC11252721/" } ] }, { "report_id": "S13", "title": "Flamingo Pharma UK Ltd. Thiamine Hydrochloride 100 mg Tablets — Summary of Product Characteristics", "url": "https://www.medicines.org.uk/emc/product/13528/smpc", "report_type": "Separate authorized-product SmPC · Historical full text", "existence": "Stored bibliography/historical access attempts. No external lookup of current existence or corrections/retractions was performed in the current work.", "acquired_read": "The designated retained stored summaries were actually read. External/old separate originals have not been read in the current work.", "study_family": null, "independent_replication": "Distinguish actual report roles/families from access attempts, and do not count the 23 entries as 23 clinical trials.", "observed_result": "This is safety information for a separate authorized product and does not establish the trial product's salt, manufacturer or excipients.", "result_level": "A stored summary within the scope of historical extraction/access; this is not new verification of original clinical materials in the current work.", "source_evidence_date": "2026-09-16", "materials": [ { "material_type": "Authorized-product SmPC HTML", "public_status": "Unverified (no external lookup in the current work)", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-04", "qualification": "Distinguish historical success/failure from current nonattempted access and reading of retained stored summaries", "material_id": "S13-M1", "url": null, "parent_url": "https://www.medicines.org.uk/emc/product/13528/smpc" } ], "links": [ { "label": "Source", "url": "https://www.medicines.org.uk/emc/product/13528/smpc" } ] }, { "report_id": "S14", "title": "NIH Office of Dietary Supplements. Thiamin — Fact Sheet for Health Professionals", "url": "https://ods.od.nih.gov/factsheets/Thiamin-HealthProfessional/", "report_type": "Official nutrition/safety explanation · Historical full text", "existence": "Stored bibliography/historical access attempts. No external lookup of current existence or corrections/retractions was performed in the current work.", "acquired_read": "The designated retained stored summaries were actually read. External/old separate originals have not been read in the current work.", "study_family": null, "independent_replication": "Distinguish actual report roles/families from access attempts, and do not count the 23 entries as 23 clinical trials.", "observed_result": "The absence of an upper intake level is not interpreted as unlimited safety. General nutritional information is not kidney-disease-specific dose prescribing.", "result_level": "A stored summary within the scope of historical extraction/access; this is not new verification of original clinical materials in the current work.", "source_evidence_date": "2026-09-16", "materials": [ { "material_type": "Official nutrition fact sheet HTML", "public_status": "Unverified (no external lookup in the current work)", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-04", "qualification": "Distinguish historical success/failure from current nonattempted access and reading of retained stored summaries", "material_id": "S14-M1", "url": null, "parent_url": "https://ods.od.nih.gov/factsheets/Thiamin-HealthProfessional/" } ], "links": [ { "label": "Source", "url": "https://ods.od.nih.gov/factsheets/Thiamin-HealthProfessional/" } ] }, { "report_id": "S15", "title": "Clinical Trials Registry–India official portal", "url": "https://ctri.nic.in/Clinicaltrials/searchbyctri.php", "report_type": "CTRI access attempt · Actual registry record not obtained", "existence": "Stored bibliography/historical access attempts. No external lookup of current existence or corrections/retractions was performed in the current work.", "acquired_read": "The designated retained stored summaries were actually read. External/old separate originals have not been read in the current work.", "study_family": null, "independent_replication": "Distinguish actual report roles/families from access attempts, and do not count the 23 entries as 23 clinical trials.", "observed_result": "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.", "result_level": "A stored summary within the scope of historical extraction/access; this is not new verification of original clinical materials in the current work.", "source_evidence_date": "2026-09-16", "materials": [ { "material_type": "CTRI lookup screen/actual registry record", "public_status": "Unverified (no external lookup in the current work)", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-04", "qualification": "Distinguish historical success/failure from current nonattempted access and reading of retained stored summaries", "material_id": "S15-M1", "url": null, "parent_url": "https://ctri.nic.in/Clinicaltrials/searchbyctri.php" } ], "links": [ { "label": "Source", "url": "https://ctri.nic.in/Clinicaltrials/searchbyctri.php" } ] }, { "report_id": "S16", "title": "Thai Clinical Trials Registry official portal", "url": "https://www.thaiclinicaltrials.org/", "report_type": "Thai registry discovery · Homepage/search incomplete", "existence": "Stored bibliography/historical access attempts. No external lookup of current existence or corrections/retractions was performed in the current work.", "acquired_read": "The designated retained stored summaries were actually read. External/old separate originals have not been read in the current work.", "study_family": null, "independent_replication": "Distinguish actual report roles/families from access attempts, and do not count the 23 entries as 23 clinical trials.", "observed_result": "The Phrawong trial's registration number was not verified. Do not conclude that it was unregistered.", "result_level": "A stored summary within the scope of historical extraction/access; this is not new verification of original clinical materials in the current work.", "source_evidence_date": "2026-09-16", "materials": [ { "material_type": "Thai registry homepage/search results", "public_status": "Unverified (no external lookup in the current work)", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-04", "qualification": "Distinguish historical success/failure from current nonattempted access and reading of retained stored summaries", "material_id": "S16-M1", "url": null, "parent_url": "https://www.thaiclinicaltrials.org/" } ], "links": [ { "label": "Source", "url": "https://www.thaiclinicaltrials.org/" } ] }, { "report_id": "S17", "title": "ClinicalTrials.gov NCT06322212", "url": "https://clinicaltrials.gov/study/NCT06322212", "report_type": "Unacquired NCT registry lead · Shell/API failure", "existence": "Stored bibliography/historical access attempts. No external lookup of current existence or corrections/retractions was performed in the current work.", "acquired_read": "The designated retained stored summaries were actually read. External/old separate originals have not been read in the current work.", "study_family": null, "independent_replication": "Distinguish actual report roles/families from access attempts, and do not count the 23 entries as 23 clinical trials.", "observed_result": "Do not infer participants' CKD eligibility or renal-function results from a CKD mention in background literature.", "result_level": "A stored summary within the scope of historical extraction/access; this is not new verification of original clinical materials in the current work.", "source_evidence_date": "2026-09-16", "materials": [ { "material_type": "NCT structured registry body", "public_status": "Unverified (no external lookup in the current work)", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-04", "qualification": "Distinguish historical success/failure from current nonattempted access and reading of retained stored summaries", "material_id": "S17-M1", "url": null, "parent_url": "https://clinicaltrials.gov/study/NCT06322212" } ], "links": [ { "label": "Source", "url": "https://clinicaltrials.gov/study/NCT06322212" } ] }, { "report_id": "S18", "title": "ClinicalTrials.gov NCT01473914 — Trace Element Replenishment in Hemodialysis", "url": "https://clinicaltrials.gov/study/NCT01473914", "report_type": "Combination registry lead · Historical index", "existence": "Stored bibliography/historical access attempts. No external lookup of current existence or corrections/retractions was performed in the current work.", "acquired_read": "The designated retained stored summaries were actually read. External/old separate originals have not been read in the current work.", "study_family": null, "independent_replication": "Distinguish actual report roles/families from access attempts, and do not count the 23 entries as 23 clinical trials.", "observed_result": "This is a multinutrient formulation lead; efficacy is not attributed to single-ingredient thiamine.", "result_level": "A stored summary within the scope of historical extraction/access; this is not new verification of original clinical materials in the current work.", "source_evidence_date": "2026-09-16", "materials": [ { "material_type": "NCT registry index", "public_status": "Unverified (no external lookup in the current work)", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-04", "qualification": "Distinguish historical success/failure from current nonattempted access and reading of retained stored summaries", "material_id": "S18-M1", "url": null, "parent_url": "https://clinicaltrials.gov/study/NCT01473914" } ], "links": [ { "label": "Source", "url": "https://clinicaltrials.gov/study/NCT01473914" } ] }, { "report_id": "S19", "title": "Thiamine status in end-stage chronic kidney disease patients — PMID 30182293", "url": "https://europepmc.org/article/med/30182293", "report_type": "ESRD status observation discovered · Historical index", "existence": "Stored bibliography/historical access attempts. No external lookup of current existence or corrections/retractions was performed in the current work.", "acquired_read": "The designated retained stored summaries were actually read. External/old separate originals have not been read in the current work.", "study_family": "TF06", "independent_replication": "Distinguish actual report roles/families from access attempts, and do not count the 23 entries as 23 clinical trials.", "observed_result": "Observational nutritional-status data are not a causal renal-function effect of oral treatment.", "result_level": "A stored summary within the scope of historical extraction/access; this is not new verification of original clinical materials in the current work.", "source_evidence_date": "2026-09-16", "materials": [ { "material_type": "Article bibliography/index", "public_status": "Unverified (no external lookup in the current work)", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-04", "qualification": "Distinguish historical success/failure from current nonattempted access and reading of retained stored summaries", "material_id": "S19-M1", "url": null, "parent_url": "https://europepmc.org/article/med/30182293" } ], "links": [ { "label": "Source", "url": "https://europepmc.org/article/med/30182293" } ] }, { "report_id": "S20", "title": "Li et al. Associations between early thiamine administration and clinical outcomes in critically ill patients with acute kidney injury", "url": "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", "report_type": "Critically ill AKI association discovered · Historical abstract", "existence": "Stored bibliography/historical access attempts. No external lookup of current existence or corrections/retractions was performed in the current work.", "acquired_read": "The designated retained stored summaries were actually read. External/old separate originals have not been read in the current work.", "study_family": "TF07", "independent_replication": "Distinguish actual report roles/families from access attempts, and do not count the 23 entries as 23 clinical trials.", "observed_result": "Critically ill patients with acute kidney injury are not recast as a chronic CKD oral single-ingredient trial.", "result_level": "A stored summary within the scope of historical extraction/access; this is not new verification of original clinical materials in the current work.", "source_evidence_date": "2026-09-16", "materials": [ { "material_type": "Original article abstract", "public_status": "Unverified (no external lookup in the current work)", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-04", "qualification": "Distinguish historical success/failure from current nonattempted access and reading of retained stored summaries", "material_id": "S20-M1", "url": null, "parent_url": "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" } ], "links": [ { "label": "Source", "url": "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" } ] }, { "report_id": "S21", "title": "Bukhari et al. thiamine transporter expression in experimental chronic kidney disease", "url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC3164444/", "report_type": "Animal CKD mechanism study discovered · Historical index", "existence": "Stored bibliography/historical access attempts. No external lookup of current existence or corrections/retractions was performed in the current work.", "acquired_read": "The designated retained stored summaries were actually read. External/old separate originals have not been read in the current work.", "study_family": "TF08", "independent_replication": "Distinguish actual report roles/families from access attempts, and do not count the 23 entries as 23 clinical trials.", "observed_result": "This is animal/mechanistic research, not counted as evidence of renal-function efficacy in humans.", "result_level": "A stored summary within the scope of historical extraction/access; this is not new verification of original clinical materials in the current work.", "source_evidence_date": "2026-09-16", "materials": [ { "material_type": "Animal-study bibliography/index", "public_status": "Unverified (no external lookup in the current work)", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-04", "qualification": "Distinguish historical success/failure from current nonattempted access and reading of retained stored summaries", "material_id": "S21-M1", "url": null, "parent_url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC3164444/" } ], "links": [ { "label": "Source", "url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC3164444/" } ] }, { "report_id": "S22", "title": "Khon Kaen University research publication catalogue — 2025", "url": "https://medres.kku.ac.th/mdpaper/dbresearch/show_pub_num_db3_2/18/2025", "report_type": "Institutional bibliography · Same TF02 report", "existence": "Stored bibliography/historical access attempts. No external lookup of current existence or corrections/retractions was performed in the current work.", "acquired_read": "The designated retained stored summaries were actually read. External/old separate originals have not been read in the current work.", "study_family": "TF02", "independent_replication": "Distinguish actual report roles/families from access attempts, and do not count the 23 entries as 23 clinical trials.", "observed_result": "This is for bibliographic verification, not material that verifies route, salt or detailed results.", "result_level": "A stored summary within the scope of historical extraction/access; this is not new verification of original clinical materials in the current work.", "source_evidence_date": "2026-09-16", "materials": [ { "material_type": "Institutional bibliography page", "public_status": "Unverified (no external lookup in the current work)", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-04", "qualification": "Distinguish historical success/failure from current nonattempted access and reading of retained stored summaries", "material_id": "S22-M1", "url": null, "parent_url": "https://medres.kku.ac.th/mdpaper/dbresearch/show_pub_num_db3_2/18/2025" } ], "links": [ { "label": "Source", "url": "https://medres.kku.ac.th/mdpaper/dbresearch/show_pub_num_db3_2/18/2025" } ] }, { "report_id": "S23", "title": "PubMed native query access attempt", "url": "https://pubmed.ncbi.nlm.nih.gov/?term=thiamine+chronic+kidney+disease+randomized", "report_type": "PubMed query attempt · Error/no result set", "existence": "Stored bibliography/historical access attempts. No external lookup of current existence or corrections/retractions was performed in the current work.", "acquired_read": "The designated retained stored summaries were actually read. External/old separate originals have not been read in the current work.", "study_family": null, "independent_replication": "Distinguish actual report roles/families from access attempts, and do not count the 23 entries as 23 clinical trials.", "observed_result": "This is not represented as a completed PubMed database search.", "result_level": "A stored summary within the scope of historical extraction/access; this is not new verification of original clinical materials in the current work.", "source_evidence_date": "2026-09-16", "materials": [ { "material_type": "PubMed search result set", "public_status": "Unverified (no external lookup in the current work)", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-04", "qualification": "Distinguish historical success/failure from current nonattempted access and reading of retained stored summaries", "material_id": "S23-M1", "url": null, "parent_url": "https://pubmed.ncbi.nlm.nih.gov/?term=thiamine+chronic+kidney+disease+randomized" } ], "links": [ { "label": "Source", "url": "https://pubmed.ncbi.nlm.nih.gov/?term=thiamine+chronic+kidney+disease+randomized" } ] } ], "method_sources": [ { "id": "M03", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03", "section": "§3.1, §3.2.1–3.2.3, MECIR C5/C7/C13", "official_principle": "Clearly record the question, eligibility criteria and reasons for changes, and distinguish variations in the intervention.", "review_level": "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." }, { "id": "M04", "version": "Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04", "section": "§4.5, §4.6.1–4.6.3, MECIR C42", "official_principle": "Distinguish and link studies and reports, and do not omit a study solely because its outcomes are not reported.", "review_level": "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." }, { "id": "M08", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08", "section": "§8.1–8.2.3, Table 8.2.a", "official_principle": "Hold the outcome and effect of interest fixed, then assess randomization, deviations, missing data, measurement and selective reporting.", "review_level": "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." }, { "id": "M15", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15", "section": "§15.2.4, §15.3.1–15.3.3", "official_principle": "Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.", "review_level": "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." }, { "id": "M19", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19", "section": "§19.1.2, §19.2.1–19.2.4", "official_principle": "Questions about harms may require designs, populations and follow-up different from efficacy questions. Case reports do not establish incidence.", "review_level": "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." } ], "status_dictionary": { "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." }, "study_overlap": { "state": "The stored manuscript records 1 direct trial family and 40 randomized participants for this fixed question. These are report links in the stored manuscript. TF01 · Direct pilot RCT · Historical full text/PDF, 5 pages · This is one trial. Author uploads, publisher HTML, PDF and PubMed are not counted as separate replications. Salt and exact analyzed denominators remain unverified. (S01) / TF02 · Adjacent CKD3 RCT · Historical publisher abstract/metadata/graphical abstract · 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. (S02) / TF01 · Critical letter · Historical HTML/PDF text · 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. (S03) / TF01 · Authors' reply · Historical preview/bibliography · The full reply was not read. Do not state that the authors' substantive response to the critique was verified. (S04) / TF01-linked_unresolved · Companion risk-factor report discovered · Historical index/abstract · 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. (S05) / TF01-linked_unresolved · Companion enzyme report discovered · Historical abstract/registry index · 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. (S06) / TF01-linked_unresolved · Companion protein-marker report discovered · Historical index · These are protein biomarkers, not the locked renal-function endpoint. Potential overlap prevents counting additional participants. (S07) / TF01-linked_unresolved · Companion enzyme report discovered · Historical search index (record unread) · 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. (S08) / TF03 · RCT of a different derivative · Historical primary abstract · Benfotiamine is separate from ordinary thiamine. That trial's effects, denominators and safety are not imported into this page. (S09) / TF04 · Combination/dialysis cognition trial · Historical screening materials · 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. (S10) / TF05 · Single-dose ESRD pharmacokinetics · Historical abstract · 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. (S11) / None · Review · Historical HTML (discovery/estimate provenance unresolved) · 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. (S12) / None · Separate authorized-product SmPC · Historical full text · This is safety information for a separate authorized product and does not establish the trial product's salt, manufacturer or excipients. (S13) / None · Official nutrition/safety explanation · Historical full text · The absence of an upper intake level is not interpreted as unlimited safety. General nutritional information is not kidney-disease-specific dose prescribing. (S14) / None · CTRI access attempt · Actual registry record not obtained · 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. (S15) / None · Thai registry discovery · Homepage/search incomplete · The Phrawong trial's registration number was not verified. Do not conclude that it was unregistered. (S16) / None · Unacquired NCT registry lead · Shell/API failure · Do not infer participants' CKD eligibility or renal-function results from a CKD mention in background literature. (S17) / None · Combination registry lead · Historical index · This is a multinutrient formulation lead; efficacy is not attributed to single-ingredient thiamine. (S18) / TF06 · ESRD status observation discovered · Historical index · Observational nutritional-status data are not a causal renal-function effect of oral treatment. (S19) / TF07 · Critically ill AKI association discovered · Historical abstract · Critically ill patients with acute kidney injury are not recast as a chronic CKD oral single-ingredient trial. (S20) / TF08 · Animal CKD mechanism study discovered · Historical index · This is animal/mechanistic research, not counted as evidence of renal-function efficacy in humans. (S21) / TF02 · Institutional bibliography · Same TF02 report · This is for bibliographic verification, not material that verifies route, salt or detailed results. (S22) / None · PubMed query attempt · Error/no result set · This is not represented as a completed PubMed database search. (S23) This is not expanded into the total number of unique trials or the sum of participants across all adjacent materials. Verification of retained summaries is distinguished from nonreading of external original materials in the current work; report and family labels are not summed into total trial or participant counts.", "unique_trial_count": null, "unique_participant_count": null, "reason": "The stored manuscript records 1 direct trial family and 40 randomized participants for this fixed question. These are report links in the stored manuscript. TF01 · Direct pilot RCT · Historical full text/PDF, 5 pages · This is one trial. Author uploads, publisher HTML, PDF and PubMed are not counted as separate replications. Salt and exact analyzed denominators remain unverified. (S01) / TF02 · Adjacent CKD3 RCT · Historical publisher abstract/metadata/graphical abstract · 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. (S02) / TF01 · Critical letter · Historical HTML/PDF text · 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. (S03) / TF01 · Authors' reply · Historical preview/bibliography · The full reply was not read. Do not state that the authors' substantive response to the critique was verified. (S04) / TF01-linked_unresolved · Companion risk-factor report discovered · Historical index/abstract · 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. (S05) / TF01-linked_unresolved · Companion enzyme report discovered · Historical abstract/registry index · 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. (S06) / TF01-linked_unresolved · Companion protein-marker report discovered · Historical index · These are protein biomarkers, not the locked renal-function endpoint. Potential overlap prevents counting additional participants. (S07) / TF01-linked_unresolved · Companion enzyme report discovered · Historical search index (record unread) · 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. (S08) / TF03 · RCT of a different derivative · Historical primary abstract · Benfotiamine is separate from ordinary thiamine. That trial's effects, denominators and safety are not imported into this page. (S09) / TF04 · Combination/dialysis cognition trial · Historical screening materials · 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. (S10) / TF05 · Single-dose ESRD pharmacokinetics · Historical abstract · 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. (S11) / None · Review · Historical HTML (discovery/estimate provenance unresolved) · 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. (S12) / None · Separate authorized-product SmPC · Historical full text · This is safety information for a separate authorized product and does not establish the trial product's salt, manufacturer or excipients. (S13) / None · Official nutrition/safety explanation · Historical full text · The absence of an upper intake level is not interpreted as unlimited safety. General nutritional information is not kidney-disease-specific dose prescribing. (S14) / None · CTRI access attempt · Actual registry record not obtained · 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. (S15) / None · Thai registry discovery · Homepage/search incomplete · The Phrawong trial's registration number was not verified. Do not conclude that it was unregistered. (S16) / None · Unacquired NCT registry lead · Shell/API failure · Do not infer participants' CKD eligibility or renal-function results from a CKD mention in background literature. (S17) / None · Combination registry lead · Historical index · This is a multinutrient formulation lead; efficacy is not attributed to single-ingredient thiamine. (S18) / TF06 · ESRD status observation discovered · Historical index · Observational nutritional-status data are not a causal renal-function effect of oral treatment. (S19) / TF07 · Critically ill AKI association discovered · Historical abstract · Critically ill patients with acute kidney injury are not recast as a chronic CKD oral single-ingredient trial. (S20) / TF08 · Animal CKD mechanism study discovered · Historical index · This is animal/mechanistic research, not counted as evidence of renal-function efficacy in humans. (S21) / TF02 · Institutional bibliography · Same TF02 report · This is for bibliographic verification, not material that verifies route, salt or detailed results. (S22) / None · PubMed query attempt · Error/no result set · This is not represented as a completed PubMed database search. (S23) This is not expanded into the total number of unique trials or the sum of participants across all adjacent materials. Verification of stored summaries is distinguished from nonreading of external original materials in the current work; report and family labels are not summed into total trial or participant counts." }, "history": [ { "date": "2026-11-07", "kind": "Separation of public-facing display and data", "view_version": "1.0", "change": "Public-facing display and data were created from the existing 39 items. No new clinical search, change in verification status or scoring was performed." } ], "language": "en", "translation_date": "2026-11-07" }