NCT00197678

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

Comparison of Two Multivitamin Dosage Regimens in the Prevention of Adverse Pregnancy Outcomes Among HIV-Positive Women From Tanzania

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,141 (actual)
• Sponsor: Harvard School of Public Health (HSPH) · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• HIV Infections

Interventions

Type	Name	Description
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

Timeline

• Start date: 2002-11-01
• Primary completion: 2005-07-01
• Completion: 2005-07-01
• First posted: 2005-09-20
• Last updated: 2010-11-11

Locations

1 site across 1 country: United States