A Trial of Micronutrients and Adverse Pregnancy Outcomes
- Conditions
- PregnancyPremature BirthInfant, Low Birth WeightPregnancy Outcomes
- Interventions
- Dietary Supplement: Multivitamins-vitamins B-complex, C, and EDietary Supplement: Placebo
- Registration Number
- NCT00197548
- Lead Sponsor
- Harvard School of Public Health (HSPH)
- Brief Summary
The purpose of this study is to examine the efficacy of multivitamin supplementation on fetal loss, low birth weight and severe preterm birth in healthy (HIV negative) women.
- Detailed Description
Fetal loss, low birth weight and preterm birth are major public health problems worldwide, particularly in developing countries. Birth outcomes are also major predictors of child health and survival in infancy and beyond. The purpose of this study is to examine the efficacy of multivitamin supplementation on fetal loss, low birth weight and severe preterm birth in healthy (HIV negative) women. We also aim to determine whether the potentially protective effect of multivitamin supplements on the risks of low birth weight and preterm birth translate into a sustained reduction in infant mortality.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 8468
- HIV negative
- 12-26 weeks gestational age at screening visit
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Multivitamins Multivitamins-vitamins B-complex, C, and E Multivitamins-vitamins B-complex, C, and E Placebo Placebo Placebo pill
- Primary Outcome Measures
Name Time Method Fetal loss, low birth weight and pre-term birth. Delivery
- Secondary Outcome Measures
Name Time Method Child morbidity and mortality; child growth 12 months postpartum