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A Trial of Micronutrients and Adverse Pregnancy Outcomes

NCT00197548 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 8468

Last updated 2010-11-11

No results posted yet for this study

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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • Muhimbili University of Health and Allied Sciences

    collaborator OTHER

  • Harvard School of Public Health (HSPH)

    lead OTHER

Principal Investigators

  • Wafaie W Fawzi, MD,DrPh · Harvard School of Public Health (HSPH)

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-08-31
Primary Completion
2004-12-31
Completion
2006-07-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00197548 on ClinicalTrials.gov