Vitamins, Breastmilk HIV Shedding, and Child Health

President and Fellows of Harvard College

Status: Completed

Conditions: Maternal and Child Health Outcomes

Treatments: Dietary Supplement: Vitamin A alone; Dietary Supplement: Multivitamins excluding vitamin A; Dietary Supplement: multivitamins including vitamin A; Other: Placebo

Study type: Observational

Funder types: Other

Identifiers

NCT00197756

HD45134

Details and patient eligibility

About

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.

Full 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

Enrollment: 771 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

771 participants in 4 patient groups

Vitamin A

Description:

Participants in the in the parent study who had been randomized to receive either Vitamin A alone or multivitamins including vitamin A.

Treatment:

Dietary Supplement: Vitamin A alone

No Vitamin A

Description:

Participants in the parent study who were randomized to receive either multivitamins excluding vitamin A, or placebo.

Treatment:

Other: Placebo

Dietary Supplement: Multivitamins excluding vitamin A

Dietary Supplement: multivitamins including vitamin A

Multivitamins

Description:

Participants in the parent study who were randomized to receive multivitamins including vitamin A or multivitamins excluding vitamin A

Treatment:

Dietary Supplement: Multivitamins excluding vitamin A

Dietary Supplement: Vitamin A alone

Dietary Supplement: multivitamins including vitamin A

No Multivitamins

Description:

Participants from the parent study who had been randomized to vitamin A alone or placebo

Treatment:

Other: Placebo

Dietary Supplement: Vitamin A alone