Vitamins, Breastmilk HIV Shedding, and Child Health

This study has been completed.
Sponsor:
Collaborator:
Muhimbili University of Health and Allied Sciences
Information provided by:
Harvard School of Public Health
ClinicalTrials.gov Identifier:
NCT00197756
First received: September 12, 2005
Last updated: August 20, 2009
Last verified: August 2009

September 12, 2005
August 20, 2009
September 2004
August 2007   (final data collection date for primary outcome measure)
  • cell-free viral load and/or cell-associated proviral load in breast milk [ Time Frame: Delivery, 3 months, and 6 months after delivery ] [ Designated as safety issue: Yes ]
  • concentration of vitamins A, B12, and E in breast milk [ Time Frame: Delivery, 3 months, and 6 months post-delivery ] [ Designated as safety issue: No ]
  • subclinical mastitis [ Time Frame: Delivery, 3 months, and 6 months after delivery ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00197756 on ClinicalTrials.gov Archive Site
  • post-natal mother-to-child transmission of HIV [ Time Frame: Delivery, 3 months, and 6 months post-delivery ] [ Designated as safety issue: No ]
  • infant mortality and morbidity from diarrhea [ Time Frame: Delivery, 3 months and 6 months after delivery ] [ Designated as safety issue: No ]
  • a.) CCR5 expression in differentiating monocytes and differentiated monocyte-derived macrophages [ Time Frame: N/A (in vitro experiment) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Vitamins, Breastmilk HIV Shedding, and Child Health
Vitamins, Breastmilk HIV Shedding, and Child Health

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

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

Breast milk samples collected from breast at delivery and at 3 month intervals thereafter.

Non-Probability Sample

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.

Maternal and Child Health Outcomes
  • Dietary Supplement: Vitamin A alone
    30 mg beta-carotene plus 5000 IU preformed vitamin A) taken orally once per during pregnancy and lactation
  • Dietary Supplement: Multivitamins 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 Supplement: multivitamins 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
  • Other: Placebo
    Placebo pill taken orally once per day during pregnancy and lactation
  • Vitamin A
    Participants in the in the parent study who had been randomized to receive either Vitamin A alone or multivitamins including vitamin A.
    Intervention: Dietary Supplement: Vitamin A alone
  • No Vitamin A
    Participants in the parent study who were randomized to receive either multivitamins excluding vitamin A, or placebo.
    Interventions:
    • Dietary Supplement: Multivitamins excluding vitamin A
    • Dietary Supplement: multivitamins including vitamin A
    • Other: Placebo
  • Multivitamins
    Participants in the parent study who were randomized to receive multivitamins including vitamin A or multivitamins excluding vitamin A
    Interventions:
    • Dietary Supplement: Vitamin A alone
    • Dietary Supplement: Multivitamins excluding vitamin A
    • Dietary Supplement: multivitamins including vitamin A
  • No Multivitamins
    Participants from the parent study who had been randomized to vitamin A alone or placebo
    Interventions:
    • Dietary Supplement: Vitamin A alone
    • Other: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
771
August 2007
August 2007   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00197756
HD45134
No
Eduardo Villamor, MD, DrPH, Harvard School of Public Health
Harvard School of Public Health
Muhimbili University of Health and Allied Sciences
Principal Investigator: Eduardo Villamor, MD,DrPH Harvard School of Public Health
Harvard School of Public Health
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP