Clinical trial NCT00197756: Vitamins, Breastmilk HIV Shedding, and Child Health
Official title: Vitamins, Breastmilk HIV Shedding, and Child Health
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Maternal and Child Health Outcomes
Keywords: HIV
Breastfeeding
Vitamins
Tanzania
Children
Lead sponsor: Harvard School of Public Health (HSPH)
Sponsor class: OTHER
Collaborators: name: Muhimbili University of Health and Allied Sciences
First posted: 2005-09-20
Enrollment: 771
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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

Eligibility 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

Primary outcomes:
measure: cell-free viral load and/or cell-associated proviral load in breast milk
timeFrame: Delivery, 3 months, and 6 months after delivery
measure: concentration of vitamins A, B12, and E in breast milk
timeFrame: Delivery, 3 months, and 6 months post-delivery
measure: subclinical mastitis
timeFrame: Delivery, 3 months, and 6 months after delivery
Secondary outcomes:
measure: post-natal mother-to-child transmission of HIV
timeFrame: Delivery, 3 months, and 6 months post-delivery
measure: infant mortality and morbidity from diarrhea
timeFrame: Delivery, 3 months and 6 months after delivery
measure: a.) CCR5 expression in differentiating monocytes and differentiated monocyte-derived macrophages
timeFrame: N/A (in vitro experiment)
measure: 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.
timeFrame: N/A (in vitro experiment)
Other outcomes:
Locations:
city: Boston
country: United States
facility: Harvard School of Public Health
state: Massachusetts
Study officials:
affiliation: Harvard School of Public Health (HSPH)
name: Eduardo Villamor, MD,DrPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Villamor E, Koulinska IN, Aboud S, Murrin C, Bosch RJ, Manji KP, Fawzi WW. Effect of vitamin supplements on HIV shedding in breast milk. Am J Clin Nutr. 2010 Oct;92(4):881-6. doi: 10.3945/ajcn.2010.29339. Epub 2010 Aug 25.
citation: Webb AL, Aboud S, Furtado J, Murrin C, Campos H, Fawzi WW, Villamor E. Effect of vitamin supplementation on breast milk concentrations of retinol, carotenoids and tocopherols in HIV-infected Tanzanian women. Eur J Clin Nutr. 2009 Mar;63(3):332-9. doi: 10.1038/sj.ejcn.1602929. Epub 2007 Oct 17.