Vitamins, Breastmilk HIV Shedding, and Child Health
Completed
- Conditions
- Maternal and Child Health Outcomes
- Interventions
- Dietary Supplement: Vitamin A aloneDietary Supplement: Multivitamins excluding vitamin AOther: PlaceboDietary Supplement: multivitamins including vitamin A
- Registration Number
- NCT00197756
- Lead Sponsor
- Harvard School of Public Health (HSPH)
- Brief Summary
The purpose of this study is to analyze stored samples and data collected during the conduct of the study "A Trial of Vitamins in HIV Progression and Transmission" (HD32257). The aims are to examine the effect of vitamin supplementation on HIV infected women during pregnancy on a number of parameters in breastmilk.
- Detailed Description
The purpose of this study is to analyze stored samples and data collected during the conduct of the study "A Trial of Vitamins in HIV Progression and Transmission" (HD32257). The aims are to examine the effect of vitamin supplementation on HIV infected women during pregnancy
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 771
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description No Multivitamins Placebo Participants from the parent study who had been randomized to vitamin A alone or placebo Vitamin A Vitamin A alone Participants in the in the parent study who had been randomized to receive either Vitamin A alone or multivitamins including vitamin A. Multivitamins multivitamins including vitamin A Participants in the parent study who were randomized to receive multivitamins including vitamin A or multivitamins excluding vitamin A No Vitamin A Multivitamins excluding vitamin A Participants in the parent study who were randomized to receive either multivitamins excluding vitamin A, or placebo. No Vitamin A multivitamins including vitamin A Participants in the parent study who were randomized to receive either multivitamins excluding vitamin A, or placebo. Multivitamins Multivitamins excluding vitamin A Participants in the parent study who were randomized to receive multivitamins including vitamin A or multivitamins excluding vitamin A No Vitamin A Placebo Participants in the parent study who were randomized to receive either multivitamins excluding vitamin A, or placebo. Multivitamins Vitamin A alone Participants in the parent study who were randomized to receive multivitamins including vitamin A or multivitamins excluding vitamin A No Multivitamins Vitamin A alone Participants from the parent study who had been randomized to vitamin A alone or placebo
- Primary Outcome Measures
Name Time Method cell-free viral load and/or cell-associated proviral load in breast milk Delivery, 3 months, and 6 months after delivery concentration of vitamins A, B12, and E in breast milk Delivery, 3 months, and 6 months post-delivery subclinical mastitis Delivery, 3 months, and 6 months after delivery
- Secondary Outcome Measures
Name Time Method infant mortality and morbidity from diarrhea Delivery, 3 months and 6 months after delivery post-natal mother-to-child transmission of HIV Delivery, 3 months, and 6 months post-delivery a.) CCR5 expression in differentiating monocytes and differentiated monocyte-derived macrophages N/A (in vitro experiment) HIV-1 replication in differentiating monocytes acutely infected with a subtype C HIV-1 clone, differentiated non-dividing MDMs acutely infected with the HIV-1 MJ4 clone, and differentiated non-dividing MDMs chronically infected with the HIV-1 MJ4 clone. N/A (in vitro experiment)
Trial Locations
- Locations (1)
Harvard School of Public Health
🇺🇸Boston, Massachusetts, United States