Vitamin B6 Effects for Women Taking Birth Control Pills

This study is currently recruiting participants.
Verified August 2013 by University of Florida
Sponsor:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01128244
First received: May 20, 2010
Last updated: August 13, 2013
Last verified: August 2013

May 20, 2010
August 13, 2013
April 2010
February 2014   (final data collection date for primary outcome measure)
To evaluate if women on oral contraceptives are B6 deficient [ Time Frame: 28 days ] [ Designated as safety issue: No ]
Vitamin B6 Effects on One-Carbon Metabolism To determine if women on oral contraceptives who are B6 deficient can have the deficiency resolved after 28 days on supplemental Vitamin B6
To evaluate if women on oral contraceptives are B6 deficient [ Time Frame: 28 days ] [ Designated as safety issue: No ]
Vitamin B6 Effects on One-Carbon Metabolism To determine if women on oral contraceptives who are B^ deficient can have the deficiency resolved after 28 days on supplemental Vitamin B6
Complete list of historical versions of study NCT01128244 on ClinicalTrials.gov Archive Site
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Vitamin B6 Effects for Women Taking Birth Control Pills
Vitamin B6 Effects on One-Carbon Metabolism

This is a research study to examine levels of B6 in women on oral contraceptives.

Subjects will undergo a prescreen visit where blood is taken to determine B6 levels, If the levels are low < 30pg then they are eligible for the study. They undergo a screening visit, have a history and physical and routine labs drawn. If within normal limited admitted to the clinical research center overnight. The next morning they have two IV's inserted one in each arm. In one arm is an infusion of amino acids, serine, methionine and leucine. The other IV is used to collect blood samples. It takes 9 hours for the infusion to be completed. The subject is sent home with vitamin B6 tablets that they will take for 30 days and come in once a week for B6 level checks. At the end of the month the infusion is repeated.

Interventional
Phase 2
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Vitamin B6 Deficiency
Dietary Supplement: Vitamin B6
Women taking oral contraceptives and who are deficient in vitamin B6 will be given an infusion of amino acids before Vitamin B6 supplementation and after 28 days of supplementation
  • Experimental: Serine , Methionine , and leucine
    Women taking oral contraceptives will be given an infusion of the amino acids serine and methionine prior to vitamin B6 supplementation and after 28 days of treatment
    Intervention: Dietary Supplement: Vitamin B6
  • Experimental: glycine and leucine amino acids
    Women taking oral contraceptives will be given an infusion of the amino acids glycine and leucine prior to vitamin B6 supplementation and after 28 days of treatment
    Intervention: Dietary Supplement: Vitamin B6
  • Experimental: Serine and Methionine amino acids
    Women taking oral contraceptives will be given an infusion of the amino acids serine and methionine prior to vitamin B6 supplementation and after 28 days of treatment
    Intervention: Dietary Supplement: Vitamin B6
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
45
June 2014
February 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • healthy female subjects
  • normal screening labs
  • normal body weight
  • nonpregnant
  • Plasma PLP<20nmol/L

Exclusion Criteria:

  • history of gastrointestinal surgery
  • vitamin supplementation
  • high protein diet
  • progesterone other than norethindrone
Female
20 Years to 40 Years
Yes
Contact: Bonnie S Coats, MSN,ARNP (352) 273-9014 coatsb@medicine.ufl.edu
United States
 
NCT01128244
2RO1DKO72398-05
No
University of Florida
University of Florida
Not Provided
Principal Investigator: Jesse Gregory, PhD University of Florida
University of Florida
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP