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

Phase 3

Completed

• Conditions: HIV Infections
• Interventions: Dietary Supplement: Multivitamins-Single RDA; Dietary Supplement: Multivitamins-Multiples of RDA

• Registration Number: NCT00197678
• Lead Sponsor: Harvard School of Public Health (HSPH)

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.

Study Timeline

• Study Start: 2002-11
• Primary Completion: 2005-07
• Study Completion: 2005-07
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-20
• Status Verified: 2010-11
• Last Update Submitted: 2010-11-09
• Last Update Posted: 2010-11-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1141

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Multivitamins-Single RDA	Multivitamins-Single RDA	Multivitamins at doses resembling a single daily Recommended Dietary Allowance (RDA)
Multivitamins-Multiples of RDA	Multivitamins-Multiples of RDA	Multivitamin supplements at multiples of the Recommended Dietary Allowance (RDA)

Primary Outcome Measures

Name	Time	Method
Low birthweight (< 2500 g)	Delivery
Pre-term birth (< 36 weeks gestation)	Monthly until the 32nd week of pregnancy, once every 2 weeks from 32nd to 36th week

Trial Locations

Locations (1)

Harvard School of Public Health; 🇺🇸 Boston, Massachusetts, United States