NCT01433952

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jun 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

September 7, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 14, 2011

Completed
Last Updated

September 14, 2011

Status Verified

September 1, 2011

Enrollment Period

1.1 years

First QC Date

September 7, 2011

Last Update Submit

September 13, 2011

Conditions

Pharmacokinetics in Healthy Subjects

Outcome Measures

Primary Outcomes (2)

  • Area Under the Curve (AUC) for whole blood

    predose, 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 hours post-dose

  • Area Under the Curve (AUC) for plasma

    predose, 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 hours post-dose

Study Arms (4)

0 mg Thiamine

PLACEBO COMPARATOR
Dietary Supplement: Placebo

100 mg Thiamine

EXPERIMENTAL
Dietary Supplement: Thiamine

500 mg Thiamine

EXPERIMENTAL
Dietary Supplement: Thiamine

1500 mg Thiamine

EXPERIMENTAL
Dietary Supplement: Thiamine

Interventions

ThiamineDIETARY_SUPPLEMENT

Vitamin B1

100 mg Thiamine1500 mg Thiamine500 mg Thiamine
PlaceboDIETARY_SUPPLEMENT

Placebo

0 mg Thiamine

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age between 18 and 55

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baystate Medical Center

Springfield, Massachusetts, 01199, United States

Location

MeSH Terms

Interventions

Thiamine

Intervention Hierarchy (Ancestors)

ThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrimidines

Study Officials

  • Howard Smithline, MD

    Baystate Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2011

First Posted

September 14, 2011

Study Start

June 1, 2009

Primary Completion

July 1, 2010

Study Completion

July 1, 2010

Last Updated

September 14, 2011

Record last verified: 2011-09

Locations

US(1)