An observational study in Maternal and Child Health Outcomes, 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 2009-08-21.
Sponsored by Harvard School of Public Health (HSPH) · Observational
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.
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
Harvard School of Public Health (HSPH) is the lead sponsor of 150 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The data and samples used in this study are from HIV-infected pregnant women who participated in the "Trial of Vitamins in HIV Transmission and Progression". Between 1995 and 1997, 1,078 African, HIV positive women who were between gestatopm weeks 12 and 27 were recruited. They were followed until August 2003. This study was conducte among 771 of these women, for whom breast milk samples were available at delivery. There were no differences in baseline characteristics between this subset and the originally randomized group of 1,069.
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:
Participants in the in the parent study who had been randomized to receive either Vitamin A alone or multivitamins including vitamin A.
Dietary Supplement: Vitamin A alone
Participants in the parent study who were randomized to receive either multivitamins excluding vitamin A, or placebo.
Dietary Supplement: Multivitamins excluding vitamin A · Dietary Supplement: multivitamins including vitamin A · Other: Placebo
Participants in the parent study who were randomized to receive multivitamins including vitamin A or multivitamins excluding vitamin A
Dietary Supplement: Vitamin A alone · Dietary Supplement: Multivitamins excluding vitamin A · Dietary Supplement: multivitamins including vitamin A
Participants from the parent study who had been randomized to vitamin A alone or placebo
Dietary Supplement: Vitamin A alone · Other: Placebo
30 mg beta-carotene plus 5000 IU preformed vitamin A) taken orally once per during pregnancy and lactation
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
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
Placebo pill taken orally once per day during pregnancy and lactation
cell-free viral load and/or cell-associated proviral load in breast milk
Time frame: Delivery, 3 months, and 6 months after delivery
concentration of vitamins A, B12, and E in breast milk
Time frame: Delivery, 3 months, and 6 months post-delivery
subclinical mastitis
Time frame: Delivery, 3 months, and 6 months after delivery
post-natal mother-to-child transmission of HIV
Time frame: Delivery, 3 months, and 6 months post-delivery
infant mortality and morbidity from diarrhea
Time frame: Delivery, 3 months and 6 months after delivery
a.) CCR5 expression in differentiating monocytes and differentiated monocyte-derived macrophages
Time frame: 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.
Time frame: N/A (in vitro experiment)
This study is completed, as verified in Aug 2009. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Harvard School of Public Health (HSPH)