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Multivitamin Dosage Regimens in the Prevention of Adverse Pregnancy Outcomes Among HIV-Positive Women

NCT00197678 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1141

Last updated 2010-11-11

No results posted yet for this study

Summary

The purpose of this study is to examine effects of daily administration of multivitamin supplements at doses resembling the Recommended Dietary Allowance (RDA) during pregnancy to HIV positive women decreases the risks of low birth weight (\<2500 g), and pre-term birth (\< 37 weeks gestation), compared to multivitamin supplements at doses above the RDA.

Conditions

  • HIV Infections

Interventions

DIETARY_SUPPLEMENT

Multivitamins-Multiples of RDA

20 mg B1, 20 mg B2, 25 mg B6, 50 mcg B12, 100 mg niacin, 500 mg C, 30 mg E, 0.8 mg folic acid taken orally once per day until 6 weeks after delivery

DIETARY_SUPPLEMENT

Multivitamins-Single RDA

1.4 mg B1, 1.4 mg B2, 1.9 mg B6, 50 mcg B12, 100 mg niacin, 70 mg C, 10 mg E, and 0.4 mg folic acid taken orally once per day until 6 weeks 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
2002-11-30
Primary Completion
2005-07-31
Completion
2005-07-31

Countries

  • United States

Study Locations

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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 NCT00197678 on ClinicalTrials.gov