Pharmacokinetics of Oral Thiamine

Completed · Phase 1 · Has a placebo group

Conditions studied: Pharmacokinetics in Healthy Subjects

In brief

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.

Key facts

Study ID

NCT01433952

Run by

Baystate Medical Center

People needed

14

Starts

2009-06-01

Expected to finish

2010-07-01

Last updated by the study team

2011-09-14

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Age between 18 and 55

You may not qualify if…

• Non dietary thiamine supplement within two weeks of the start of the study or during the study
• History of thiamine deficiency
• Anemia (Hgb<10)
• History of gastrointestinal absorption disorders
• Taking prescription or over-the-counter medication
• Pregnant or breast feeding a child
• Alcohol and or drug abuse
• Smoker

Where it is running

• Baystate Medical Center — Springfield, Massachusetts, United States

Full record on ClinicalTrials.gov

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