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Pharmacokinetics of Oral Thiamine

NCT01433952 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2011-09-14

No results posted yet for this 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.

Conditions

  • Pharmacokinetics in Healthy Subjects

Interventions

DIETARY_SUPPLEMENT

Thiamine

Vitamin B1

DIETARY_SUPPLEMENT

Placebo

Placebo

Sponsors & Collaborators

  • Baystate Medical Center

    lead OTHER

Principal Investigators

  • Howard Smithline, MD · Baystate Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2010-07-31
Completion
2010-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01433952 on ClinicalTrials.gov