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This study compares two doses of folic acid (400 versus 800 mcg per day) in healthy pregnant women. Healthy women with a single-baby pregnancy under 10 weeks and a body mass index of 18.5-35 were able to take part. It was conducted as a study with no assigned phase and has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
Inclusion Criteria: * Healthy women with singleton pregnancy * \< 10 weeks gestation at enrollment * body mass index 18.5 - 35.0 kg/m2 * willingness to comply with study protocol ( i.e. take assigned daily prenatal vitamin; complete diet recall and study questionnaire) * not consuming super-fortified ready-to-eat cereal products (with \> 100% RDA for folate per serving) Exclusion Criteria: * BMI \< 18.5 or \> 35.0 kg/m2 * use of prescription drugs * anemia * chronic disease (diabetes, hypertension, epilepsy, cancer, kidney disease, cardiovascular disease) * acute illness (e.g. pneumonia, urinary tract infection, mononucleosis) * use of antibiotics in past 2 weeks * follows vegan dietary regime * current smoker * typical alcohol consumption of 2 or more drinks per day * having undergone in vitro fertilization treatment * carrying more than one fetus * pregnancy-associated complications (i.e gestational diabetes, pre-eclampsia)