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Completed

NCT Number: NCT00197548

A Trial of Micronutrients and Adverse Pregnancy Outcomes

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.

Completed

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Key information

Conditions

Pregnancy Female Urogenital Diseases and Pregnancy Complications Infant, Low Birth Weight Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Pregnancy Outcomes Premature Birth Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

Multivitamins-vitamins B-complex, C, and E

Dietary Supplement

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.

Placebo

Dietary Supplement

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.

Primary outcomes

  1. Fetal loss, low birth weight and pre-term birth.

    Time frame: Delivery

Secondary outcomes

  1. Child morbidity and mortality; child growth

    Time frame: 12 months postpartum

Sponsors and collaborators

Lead sponsor

Harvard School of Public Health (HSPH)

Other

Collaborators

  • Muhimbili University of Health and Allied Sciences

Registry information

Important dates

Study start
2001
Primary completion
2004
Study completion
2006
First posted
Sep 20, 2005
Registry last updated
Nov 11, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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