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OpenTrials
Completed

NCT Number: NCT01433952

Pharmacokinetics of 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.

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Key information

Conditions

Pharmacokinetics in Healthy Subjects

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Baystate Medical Center

Springfield, Massachusetts, 01199, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Thiamine

Dietary Supplement

Vitamin B1

Placebo

Dietary Supplement

Placebo

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Baystate Medical Center

Other

Registry information

Official study title

Pharmacokinetics of High Dose Oral Thiamine

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Sep 14, 2011
Registry last updated
Sep 14, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.