Maternal and Child Health Outcomes
Conditions
Keywords
HIV, Breastfeeding, Vitamins, Tanzania, Children
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
Interventions
DIETARY_SUPPLEMENTVitamin A alone
30 mg beta-carotene plus 5000 IU preformed vitamin A) taken orally once per during pregnancy and lactation
DIETARY_SUPPLEMENTMultivitamins excluding vitamin A
30 mg thiamine, 20 mg riboflavin, 20 mg B-6, 100 mg niacin, 50 ug vitamin B-12, 500 mg vitamin C, 30 mg vitamin E, 0.8 mg folic acid taken orally once per day during pregnancy and lactation
DIETARY_SUPPLEMENTmultivitamins including vitamin A
20 mg thiamine, 20 mg riboflavin, 25 mg vitamin B6, 100 mg niacin, 50 ug vitamin B12, 500 mg vitamin C, 30 mg vitamin E, and 0.8 mg folic acid taken once per day orally during pregnancy and lactation
OTHERPlacebo
Placebo pill taken orally once per day during pregnancy and lactation
Sponsors
Muhimbili University of Health and Allied Sciences
Harvard School of Public Health (HSPH)
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
This study is analyzing samples previously collected from the study A Trial of Vitamins in HIV Progression and Transmission (HD32257). The inclusion criteria in this study was: * HIV infected women presenting to antenatal care between 12 and 27 weeks of gestation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| post-natal mother-to-child transmission of HIV | Delivery, 3 months, and 6 months post-delivery |
| 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) |
| infant mortality and morbidity from diarrhea | Delivery, 3 months and 6 months after delivery |
| a.) CCR5 expression in differentiating monocytes and differentiated monocyte-derived macrophages | N/A (in vitro experiment) |
Countries
United States
Outcome results
None listed