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Pharmacokinetics of Oral Thiamine

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Baystate Medical Center
ClinicalTrials.gov Identifier:
NCT01433952
First received: September 7, 2011
Last updated: September 13, 2011
Last verified: September 2011
  Purpose

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
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

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
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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Baystate Medical Center
ClinicalTrials.gov Identifier: NCT01433952     History of Changes
Other Study ID Numbers: 132653
Study First Received: September 7, 2011
Last Updated: September 13, 2011
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on November 25, 2014