NCT00197548

A Trial of Micronutrients and Adverse Pregnancy Outcomes

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 8,468 (actual)
• Sponsor: Harvard School of Public Health (HSPH) · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pregnancy
• Premature Birth
• Infant, Low Birth Weight
• Pregnancy Outcomes

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Multivitamins-vitamins B-complex, C, and E	One daily oral dose of 20 mg of B1, 20 mg of B2, 25 mg of B6, 100 mg of niacin, 50 mcg of B12, 500 mg of C, and 30 mg of vitamin E from randomization until delivery. Participants may continue taking this intervention until 18 months post-partum if they are re-randomized to it after delivery.
DIETARY_SUPPLEMENT	Placebo	One daily oral dose of a placebo pill taken from randomization until delivery. Participants may continue taking this intervention until 18 months post-partum if they are re-randomized to it after delivery.

Timeline

• Start date: 2001-08-01
• Primary completion: 2004-12-01
• Completion: 2006-07-01
• First posted: 2005-09-20
• Last updated: 2010-11-11