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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 is a Phase 1 study that has completed, run by Baystate Medical Center. The registered enrollment target is 14 participants.
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
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2009-06 |
| Est. Completion | 2010-07 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01433952
The ClinicalTrials.gov registry entry for NCT01433952 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 14 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Baystate Medical Center, which has 36 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01433952 reports 0 study locations.
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.
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