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Pharmacokinetics of Oral Thiamine

This study has been completed.
Information provided by (Responsible Party):
Baystate Medical Center Identifier:
First received: September 7, 2011
Last updated: September 13, 2011
Last verified: September 2011

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.

Condition Intervention Phase
Pharmacokinetics in Healthy Subjects
Dietary Supplement: Thiamine
Dietary Supplement: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Pharmacokinetics of High Dose Oral Thiamine

Resource links provided by NLM:

Further study details as provided by Baystate Medical Center:

Primary Outcome Measures:
  • 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 ]

Enrollment: 14
Study Start Date: June 2009
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 0 mg Thiamine Dietary Supplement: Placebo
Experimental: 100 mg Thiamine Dietary Supplement: Thiamine
Vitamin B1
Experimental: 500 mg Thiamine Dietary Supplement: Thiamine
Vitamin B1
Experimental: 1500 mg Thiamine Dietary Supplement: Thiamine
Vitamin B1


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01433952

United States, Massachusetts
Baystate Medical Center
Springfield, Massachusetts, United States, 01199
Sponsors and Collaborators
Baystate Medical Center
Principal Investigator: Howard Smithline, MD Baystate Medical Center
  More Information

Responsible Party: Baystate Medical Center Identifier: NCT01433952     History of Changes
Other Study ID Numbers: 132653
Study First Received: September 7, 2011
Last Updated: September 13, 2011

Additional relevant MeSH terms:
Vitamin B Complex
Growth Substances
Physiological Effects of Drugs processed this record on April 26, 2017