CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 7 enrolled
Drug / intervention
Trimethoprim +2 moredrug
Likely dose
Trimethoprim 300mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03746106
NCT03746106Phase 4Completed
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The Effect of SLC19A3 Inhibition on the Pharmacokinetics of Thiamine

University of California, San Francisco·interventional·Posted Nov 19, 2018·Updated Jan 3, 2025

In Brief

A Phase 4 clinical trial evaluating Trimethoprim, Metformin, and 1 other intervention for Vitamin B1 Deficiency and Thiamine Deficiency. Completed, enrolled 7 participants across 1 site.

Detailed Summary

In Part 1, subjects will be administered thiamine, thiamine with metformin, and thiamine with trimethoprim. Part 2 will expand on Part 1 and subjects will be administered thiamine and thiamine with trimethoprim. The goal is to determine whether taking a drug and a vitamin together affects the body's ability to absorb, distribute, and eliminate thiamine (Vitamin B1).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVitamin B1 Deficiency, Thiamine Deficiency
CountriesUnited States
CollaboratorsTufts University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of California, Davis

Timeline

Phase 4CompletedFinished
20192020202120222023202420252026
First PostedNov 19, 2018
Enrollment StartJan 28, 2019
Primary CompletionAug 10, 2023
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 7.6 years ago

Interventions

Trimethoprimdrug

300mg of trimethoprim will be given in combination with 5mg thiamine and compared to 5mg thiamine only for both Parts 1 and 2 of the study.

Metformindrug

1000mg of metformin will be given in combination with 5mg thiamine and compared to 5mg thiamine only in Part 1 of the study.

Vitamin B1dietary

5mg of thiamine will be given alone and in combination for both Parts 1 and 2 of the study.