Clinical Trial

Dose-dependent Kinetics of Thiamin in Healthy Volunteers With and Without Functional OCT1 Hepatic Transporters

Study acronym: THIAMO-1

Enrolling by Invitation

Record status

This record was last updated January 24, 2025 (before its estimated June 30, 2025 completion). Its status may not reflect the trial's current state.

Summary

This study investigates the differences in thiamin (vitamin B1) kinetic parameters in two cohorts of healthy volunteers: Cohort 1) OCT1 wild type genotypes n = 12 Cohort 2) OCT1 deficient genotypes n = 12 Participants will be selected according to their OCT1 genotypes and to achieve best matching according to sex, age, BMI, alcohol consumption, and smoking between Cohort 1 and 2, respectively. The purpose of this study is: 1. To determine the influence of OCT1 genetic variants on dose-dependent thiamin kinetics after oral administration. 2. To elucidate whether OCT1 genetic variants impact the kinetic properties of orally vs. intravenously administered thiamin.

Protocol Amendment History 2 amendments

This ClinicalTrials.gov record has been amended 2 times since 2023-11-07; most recent amendment 2025-01-21.

Status change: Completed → Enrolling by Invitation 2025-01-21

Status change: Not Yet Recruiting → Completed 2024-12-19

Trial Details

NCT Number	NCT06122701
Lead Sponsor	University Medicine Greifswald
Conditions	Healthy
Enrollment	36 participants
Start Date	2023-11-03
Primary Completion	2025-06-30 (estimated)
Study Completion	2025-08-31 (estimated)
Updated on ClinicalTrials.gov	2025-01-24