Status:
WITHDRAWN
A Study to Evaluate Folate Levels in Women Taking Oral Contraceptives
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Neural Tube Defects
Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Eligibility:
FEMALE
18-45 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to compare red blood cell folate levels in women who are taking oral contraceptives with or without folic acid
Detailed Description
Studies have shown an association between increased folic acid (a synthetic form of folate, a B-vitamin) intake and reduction of a birth defect referred to as neural tube defects (NTDs). If women usin...
Eligibility Criteria
Inclusion
- Non-pregnant post menarcheal, premenopausal females who agree to use the assigned study medication as contraception during the study
- Non-vegan
- Non-smoker or no history of tobacco use within 6 months
- Willing to follow protocol-specific prohibitions and restrictions regarding diet, smoking and use of other medications
Exclusion
- Have taken multivitamins, folic-acid containing supplements, or highly fortified (i.e., \>200 mcg folic acid/serving) cereals within 30 days of entry in to the study
- history or presence of blood clots in the veins, strokes or other blood clotting disorder, liver tumor from pervious contraceptive or estrogen use, disease of the blood vessels of the brain or heart disease, uncontrolled high blood pressure, cancer in any part of the body, diabetes mellitus with complications in the flow of blood in the body, jaundice, visual disturbance, liver disease, undiagnosed vaginal bleeding, gastric bypass surgery, ulcerative colitis or other digestive system disorders, abnormal thyroid function, Vitamin B 12 deficiency or very high red blood cell folate levels, alcohol or substance abuse, positive for drugs of abuse
- recent use of hormonal contraceptives
- on any weight reduction diet
- blood donation within 30 days of study entry
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2004
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00301587
End Date
December 1 2004
Last Update
September 20 2016
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