A Phase 3 interventional study of Multivitamins-Multiples of RDA and Multivitamins-Single RDA in HIV Infections, sponsored by Harvard School of Public Health (HSPH). Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-11-11.
Sponsored by Harvard School of Public Health (HSPH) · Phase 3, Interventional, and Prevention
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.
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.
4,340 studies on the registry are indexed under HIV Infections; 240 are open to participants now.
This study's enrollment of 1,141 is above the median of 83 across 3,312 interventional studies indexed under HIV Infections.
Browse HIV Infections studies →Harvard School of Public Health (HSPH) is the lead sponsor of 154 studies on the registry; 10 are open to participants now.
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Inclusion Criteria:
- HIV-positive pregnant women who are between 12 and 27 weeks gestation who intend to stay in Dar es Salaam until delivery.
Multivitamins at doses resembling a single daily Recommended Dietary Allowance (RDA)
Dietary Supplement: Multivitamins-Single RDA
Multivitamin supplements at multiples of the Recommended Dietary Allowance (RDA)
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
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
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
The record gives a start of Nov 2002, a primary completion of Jul 2005 and a completion of Jul 2005. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Nov 2010. You cannot join it, but the record below documents what was studied.
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