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NCT01433952 · ClinicalTrials.gov registry record · Phase 1

Pharmacokinetics of Oral Thiamine

A Phase 1 study, sponsored by Baystate Medical Center.

Completed
Registry status
Phase 1
Development phase
14
Enrollment target

NCT01433952: Completed Phase 1 study, sponsored by Baystate Medical Center.

NCT01433952 is a Phase 1 study that has completed, run by Baystate Medical Center. The registered enrollment target is 14 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01433952, a Phase 1 study, has completed, sponsored by Baystate Medical Center.

COMPLETED
Registry status
Phase 1
Development phase
14 participants
Enrollment target

Study Summary

Elevated levels of thiamine may increase cellular energy metabolism by increasing the activity of pyruvate dehydrogenase complex. This has been hypothesized to have a beneficial affect in patients with several diseases including sepsis, heart failure, and diabetes. There is limited data on the pharmacokinetics of supraphysiologic doses of oral thiamine. The aims of this study are to: * Calculate the plasma and whole blood pharmacokinetics of supraphysiologic doses of oral thiamine in healthy volunteers; * Compare the different thiamine doses on the pharmacokinetic variables using repeated measures ANOVA.

Interventions

  • DIETARY_SUPPLEMENT Placebo
  • DIETARY_SUPPLEMENT Thiamine

Trial Details

FieldValue
Enrollment Target 14 participants
Start Date 2009-06
Est. Completion 2010-07
Phase Phase 1
Baystate Medical Center

36 total trials

What the finished NCT01433952 record still lists

NCT01433952 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT01433952 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01433952 about?

NCT01433952 is a clinical study titled "Pharmacokinetics of Oral Thiamine". Elevated levels of thiamine may increase cellular energy metabolism by increasing the activity of pyruvate dehydrogenase complex. This has been hypothesized to have a beneficial affect in patients with several diseases including sepsis, heart failure, and diabetes. There is limited data on the pharm...

What is the current status of trial NCT01433952?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 14 participants. The study started on 2009-06. Estimated completion is 2010-07.

What interventions are being tested in trial NCT01433952?

The interventions under investigation include: Placebo (DIETARY_SUPPLEMENT), Thiamine (DIETARY_SUPPLEMENT).

Who is sponsoring clinical trial NCT01433952?

This trial is sponsored by Baystate Medical Center, which has 36 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01433952's enrollment target sits among peer trials

14 1844th of 2000 higher than 154 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01433952, the US trial registry maintained by the National Library of Medicine. NCT01433952 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.