NCT01433952

Pharmacokinetics of Oral Thiamine

Pharmacokinetics of High Dose Oral Thiamine

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Baystate Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
DIETARY_SUPPLEMENT	Thiamine	Vitamin B1
DIETARY_SUPPLEMENT	Placebo	Placebo

Timeline

• Start date: 2009-06-01
• Primary completion: 2010-07-01
• Completion: 2010-07-01
• First posted: 2011-09-14
• Last updated: 2011-09-14

Locations

1 site across 1 country: United States