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Vitamin B6 Dependence of One-Carbon Metabolism
This study is currently recruiting participants.
Verified by University of Florida, April 2009
First Received: April 1, 2009   Last Updated: April 7, 2009   History of Changes
Sponsored by: University of Florida
Information provided by: University of Florida
ClinicalTrials.gov Identifier: NCT00877812
  Purpose

Research study of the importance of vitamin B6 status on metabolic processes essential for human health.


Condition Intervention
Healthy Volunteers
 Drug: Methionine, Leucine and low B6 diet.

MedlinePlus related topics: Diets
Drug Information available for: Pyridoxine hydrochloride Leucine Methionine Pyridoxine Vitamin B 6
U.S. FDA Resources
Study Type: Interventional
Study Design: Diagnostic, Open Label, Single Group Assignment, Pharmacokinetics Study
Official Title: Vitamin B6 Dependence of One-Carbon Metabolism

Further study details as provided by University of Florida:

Primary Outcome Measures:
  • No direct subject benefit; study is to gain information relevant to health. The results of this study will be beneficial to the population as a whole, and this benefit outweighs the low risks. [ Time Frame: One year ] [ Designated as safety issue: No ]

Estimated Enrollment: 70
Study Start Date: January 2008
Estimated Study Completion Date: July 2010
Estimated Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Methionine, Leucine and low B6 diet.
    I.v. dosage depending upon study subject weight.
  Eligibility

Ages Eligible for Study:   20 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 20-40 years of age
  • adequate vitamin B6 levels
  • not pregnant

Exclusion Criteria:

  • abnormal labs
  • pregnancy
  • on medications
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00877812

Contacts
Contact: Jesse F Gregory, PhD (352) 392-1551 ext 226 jfgy@ufl.edu
Contact: Bonnie S Coats, ARNP (352) 392-6196 bonnie.coats@medicine.ufl.edu

Locations
United States, Florida
University of Florida Recruiting
Gainesville, Florida, United States, 32611
Contact: Bonnie S Coats, ARNP     352-392-6196     bonnie.coats@medicine.ufl.edu    
Contact: Yvonne Lamers, PhD     (352) 392-1991 ext 258     ylam@ufl.edu    
Sub-Investigator: Peter W Stacpoole, PhD, MD            
Sub-Investigator: Yvonne Lamers, PhD            
Sub-Investigator: Bonnie S Coats, ARNP            
Sponsors and Collaborators
University of Florida
Investigators
Principal Investigator: Jesse F Gregory, PhD University of Florida
  More Information

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Responsible Party: University of Florida ( Jesse F. Gregory, III, PhD )
Study ID Numbers: R01 D072398
Study First Received: April 1, 2009
Last Updated: April 7, 2009
ClinicalTrials.gov Identifier: NCT00877812     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by University of Florida:
Vitamin B6
Amino acids

Study placed in the following topic categories:
Vitamin B Complex
Pyridoxal
Vitamins
Trace Elements
 Pyridoxine
Micronutrients
Healthy
Vitamin B 6

Additional relevant MeSH terms:
Vitamin B Complex
Pyridoxal
Growth Substances
Vitamins
Physiological Effects of Drugs
 Pyridoxine
Micronutrients
Pharmacologic Actions
Vitamin B 6

ClinicalTrials.gov processed this record on May 07, 2009



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