Pharmacokinetics of Oral Thiamine

Baystate Medical Center

Status and phase: Completed; Phase 1

Conditions: Pharmacokinetics in Healthy Subjects

Treatments: Dietary Supplement: Thiamine; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01433952

132653

Details and patient eligibility

About

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.

Enrollment: 14 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

---

14 participants in 4 patient groups, including a placebo group

0 mg Thiamine

Placebo Comparator group

Treatment:

Dietary Supplement: Placebo

100 mg Thiamine

Experimental group

Treatment:

Dietary Supplement: Thiamine

500 mg Thiamine

Experimental group

Treatment:

Dietary Supplement: Thiamine

1500 mg Thiamine

Experimental group

Treatment:

Dietary Supplement: Thiamine