A Trial of Micronutrients and Adverse Pregnancy Outcomes

President and Fellows of Harvard College

Status and phase: Completed; Phase 3

Conditions: Infant, Low Birth Weight; Pregnancy Outcomes; Premature Birth; Pregnancy

Treatments: Dietary Supplement: Multivitamins-vitamins B-complex, C, and E; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00197548

HD37701

Details and patient eligibility

About

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.

Full 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.

Enrollment: 8,468 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• HIV negative
• 12-26 weeks gestational age at screening visit

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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8,468 participants in 2 patient groups, including a placebo group

Multivitamins

Active Comparator group

Description:

Multivitamins-vitamins B-complex, C, and E

Treatment:

Dietary Supplement: Multivitamins-vitamins B-complex, C, and E

Placebo

Placebo Comparator group

Description:

Placebo pill

Treatment:

Dietary Supplement: Placebo