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Pharmacokinetics of Oral Thiamine

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ClinicalTrials.gov Identifier: NCT01433952
Recruitment Status : Completed
First Posted : September 14, 2011
Last Update Posted : September 14, 2011
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Pharmacokinetics in Healthy Subjects Dietary Supplement: Thiamine Dietary Supplement: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Pharmacokinetics of High Dose Oral Thiamine
Study Start Date : June 2009
Actual Primary Completion Date : July 2010
Actual Study Completion Date : July 2010

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: 0 mg Thiamine Dietary Supplement: Placebo
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




Primary Outcome Measures :
  1. 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 ]
  2. 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 ]


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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01433952


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

Responsible Party: Baystate Medical Center
ClinicalTrials.gov Identifier: NCT01433952     History of Changes
Other Study ID Numbers: 132653
First Posted: September 14, 2011    Key Record Dates
Last Update Posted: September 14, 2011
Last Verified: September 2011

Additional relevant MeSH terms:
Thiamine
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs