Trial record 14 of 841 for:    Open Studies | "Vitamin B Complex"

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
  Purpose

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


Condition Intervention Phase
Vitamin B6 Deficiency
Dietary Supplement: Vitamin B6
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Vitamin B6 Effects on One-Carbon Metabolism

Resource links provided by NLM:


Further study details as provided by University of Florida:

Primary Outcome Measures:
  • 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


Estimated Enrollment: 45
Study Start Date: April 2010
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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: 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
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 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
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

Detailed Description:

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.

  Eligibility

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01128244

Contacts
Contact: Bonnie S Coats, MSN,ARNP (352) 273-9014 coatsb@medicine.ufl.edu

Locations
United States, Florida
Shands Hospital Recruiting
Gainesville, Florida, United States, 32610
Contact: Bonnie S Coats, MSN, ARNP    352-273-9014    coatsb@medicine.ufl.edu   
Sub-Investigator: Peter W. Stacpoole, MD, PhD         
Principal Investigator: Jesse Gregory, PhD         
Sponsors and Collaborators
University of Florida
Investigators
Principal Investigator: Jesse Gregory, PhD University of Florida
  More Information

No publications provided

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01128244     History of Changes
Other Study ID Numbers: 2RO1DKO72398-05
Study First Received: May 20, 2010
Last Updated: August 13, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Florida:
oral contraceptives
Vitamin B6
birth control pills
amino acids
Vitamin B6 deficiency
Vitamin B6 Deficiency in women on oral contraceptives

Additional relevant MeSH terms:
Vitamin B 6
Vitamin B Complex
Vitamin B 6 Deficiency
Vitamin B Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Contraceptive Agents
Contraceptives, Oral
Contraceptives, Oral, Combined
Pyridoxine
Pyridoxal
Vitamins
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contraceptive Agents, Female
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on April 17, 2014