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Completed

NCT Number: NCT00197756

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.

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Key information

Conditions

Maternal and Child Health Outcomes Behavior Breast Feeding Feeding Behavior

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Harvard School of Public Health

Boston, Massachusetts, 02115, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin A alone

Dietary Supplement

30 mg beta-carotene plus 5000 IU preformed vitamin A) taken orally once per during pregnancy and lactation

Multivitamins excluding vitamin A

Dietary Supplement

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

multivitamins including vitamin A

Dietary Supplement

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

Other

Placebo pill taken orally once per day during pregnancy and lactation

Primary outcomes

  1. cell-free viral load and/or cell-associated proviral load in breast milk

    Time frame: Delivery, 3 months, and 6 months after delivery

  2. concentration of vitamins A, B12, and E in breast milk

    Time frame: Delivery, 3 months, and 6 months post-delivery

  3. subclinical mastitis

    Time frame: Delivery, 3 months, and 6 months after delivery

Secondary outcomes

  1. post-natal mother-to-child transmission of HIV

    Time frame: Delivery, 3 months, and 6 months post-delivery

  2. infant mortality and morbidity from diarrhea

    Time frame: Delivery, 3 months and 6 months after delivery

  3. a.) CCR5 expression in differentiating monocytes and differentiated monocyte-derived macrophages

    Time frame: N/A (in vitro experiment)

  4. 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)

Sponsors and collaborators

Lead sponsor

Harvard School of Public Health (HSPH)

Other

Collaborators

  • Muhimbili University of Health and Allied Sciences

Registry information

Important dates

Study start
2004
Primary completion
2007
Study completion
2007
First posted
Sep 20, 2005
Registry last updated
Aug 21, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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