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

September 7, 2011
September 13, 2011
June 2009
July 2010   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01433952 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Pharmacokinetics of Oral Thiamine
Pharmacokinetics of High Dose Oral Thiamine

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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Pharmacokinetics in Healthy Subjects
  • Dietary Supplement: Thiamine
    Vitamin B1
  • Dietary Supplement: Placebo
    Placebo
  • Placebo Comparator: 0 mg Thiamine
    Intervention: Dietary Supplement: Placebo
  • Experimental: 100 mg Thiamine
    Intervention: Dietary Supplement: Thiamine
  • Experimental: 500 mg Thiamine
    Intervention: Dietary Supplement: Thiamine
  • Experimental: 1500 mg Thiamine
    Intervention: Dietary Supplement: Thiamine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
14
July 2010
July 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01433952
132653
No
Baystate Medical Center
Baystate Medical Center
Not Provided
Principal Investigator: Howard Smithline, MD Baystate Medical Center
Baystate Medical Center
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP