Comparison of Two Multivitamin Dosage Regimens in the Prevention of Adverse Pregnancy Outcomes Among HIV-Positive Women From Tanzania
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- HIV Infections
- Sponsor
- Harvard School of Public Health (HSPH)
- Enrollment
- 1141
- Locations
- 1
- Primary Endpoint
- Low birthweight (< 2500 g)
- Status
- Completed
- Last Updated
- 15 years ago
Overview
Brief 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.
Detailed Description
This is a randomized clinical trial conducted 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. All women receive standard prenatal care, including nevirapine for the prevention of mother-to-child transmission of HIV.
Investigators
Eligibility Criteria
Inclusion Criteria
- •HIV-positive pregnant women who are between 12 and 27 weeks gestation who intend to stay in Dar es Salaam until delivery.
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Low birthweight (< 2500 g)
Time Frame: Delivery
Pre-term birth (< 36 weeks gestation)
Time Frame: Monthly until the 32nd week of pregnancy, once every 2 weeks from 32nd to 36th week