Trial record 5 of 474 for:
Open Studies | "Vitamins"
Vitamin B6 Effects for Women Taking Birth Control Pills
This study is currently recruiting participants.
Verified March 2013 by University of Florida
Sponsor:
University of Florida
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01128244
First received: May 20, 2010
Last updated: March 25, 2013
Last verified: March 2013
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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:
Drug Information available for:
Serine
Pyridoxine hydrochloride
Racemethionine
Leucine
Methionine
Pyridoxine
Vitamin B Complex
Amino acids
U.S. FDA Resources
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: | March 25, 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 Deficiency Vitamin B Deficiency Avitaminosis Deficiency Diseases Malnutrition Nutrition Disorders Contraceptive Agents Contraceptives, Oral Contraceptives, Oral, Combined Vitamin B 6 Pyridoxine |
Pyridoxal Vitamin B Complex Vitamins Reproductive Control Agents Physiological Effects of Drugs Pharmacologic Actions Therapeutic Uses Contraceptive Agents, Female Micronutrients Growth Substances |
ClinicalTrials.gov processed this record on May 19, 2013