Pharmacokinetics of Oral Thiamine | NCT01433952

Studies
Pharmacokinetics of Oral Thiamine

NCT01433952

Sponsor

Baystate Medical Center

Status

Completed

Last Update Posted

Sep 14, 2011Estimated

Enrollment

14Actual

Phase

Phase 1

Conditions

Pharmacokinetics in Healthy Subjects

Interventions

Thiamine
Placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2009

Primary Completion Date

Jul 2010Actual

Completion Date

Jul 2010Actual

First Submitted Date

Sep 7, 2011

First Submission Date that Met QC Criteria

Sep 13, 2011

First Posted Date

Sep 14, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 13, 2011

Last Update Posted Date

Sep 14, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

14Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Thiamine	Dietary Supplement	Vitamin B1	100 mg Thiamine 1500 mg Thiamine 500 mg Thiamine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Howard Smithline, MD	Baystate Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Baystate Medical Center		Springfield	Massachusetts	01199	United States

Intervention Browse Module

MeSH Terms

ID	Term
D013831	Thiamine

Ancestor Terms

ID	Term
D013844	Thiazoles
D013457	Sulfur Compounds
D009930	Organic Chemicals
D001393	Azoles

Browse Leaves

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Browse Branches

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