Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
14 participants
INTERVENTIONAL
2009-06-30
2010-07-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
TRIPLE
Study Groups
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0 mg Thiamine
Placebo
Placebo
100 mg Thiamine
Thiamine
Vitamin B1
500 mg Thiamine
Thiamine
Vitamin B1
1500 mg Thiamine
Thiamine
Vitamin B1
Interventions
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Thiamine
Vitamin B1
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
55 Years
ALL
Yes
Sponsors
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Baystate Medical Center
OTHER
Responsible Party
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Principal Investigators
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Howard Smithline, MD
Role: PRINCIPAL_INVESTIGATOR
Baystate Medical Center
Locations
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Baystate Medical Center
Springfield, Massachusetts, United States
Countries
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Other Identifiers
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132653
Identifier Type: -
Identifier Source: org_study_id
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