A Study to Evaluate Folate Levels in Women Taking Oral Contraceptives
Neural Tube Defects, Congenital, Hereditary, and Neonatal Diseases and Abnormalities, Nervous System Malformations
About this trial
This is an interventional treatment trial for Neural Tube Defects focused on measuring spina bifida, birth defects, folic acid, nervous system diseases, folate, Vitamin B
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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