Pharmacokinetics of Oral Thiamine
Phase 1
Completed
- Conditions
- Pharmacokinetics in Healthy Subjects
- Interventions
- Dietary Supplement: PlaceboDietary Supplement: Thiamine
- Registration Number
- NCT01433952
- Lead Sponsor
- Baystate Medical Center
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 14
Inclusion Criteria
- Age between 18 and 55
Exclusion Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description 0 mg Thiamine Placebo - 100 mg Thiamine Thiamine - 500 mg Thiamine Thiamine - 1500 mg Thiamine Thiamine -
- Primary Outcome Measures
Name Time Method Area Under the Curve (AUC) for whole blood predose, 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 hours post-dose Area Under the Curve (AUC) for plasma predose, 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 hours post-dose
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Baystate Medical Center
🇺🇸Springfield, Massachusetts, United States