Pharmacokinetics of Oral Thiamine

Baystate Medical Center14 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Enrollment

Conditions

Pharmacokinetics in Healthy Subjects

Interventions

ThiamineDIETARY_SUPPLEMENT

Vitamin B1

PlaceboDIETARY_SUPPLEMENT

Placebo

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Baystate Medical Center

Springfield, Massachusetts, United States

Outcomes

Primary Outcomes

Area Under the Curve (AUC) for whole blood

Time frame: predose, 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 hours post-dose

Area Under the Curve (AUC) for plasma

Time frame: predose, 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 hours post-dose

Data from ClinicalTrials.gov

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