Vitamins, Breastmilk HIV Shedding, and Child Health

Sponsor

Harvard School of Public Health (HSPH) (Other)

Overall Status

Completed

CT.gov ID

NCT00197756

Collaborator

Muhimbili University of Health and Allied Sciences (Other)

771

Enrollment

Location

Duration (Months)

22.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Maternal and Child Health Outcomes	Dietary Supplement: Vitamin A alone Dietary Supplement: Multivitamins excluding vitamin A Dietary Supplement: multivitamins including vitamin A Other: Placebo

Detailed Description

Study Design

Study Type:

Observational

Actual Enrollment :

771 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Vitamins, Breastmilk HIV Shedding, and Child Health

Study Start Date :

Sep 1, 2004

Actual Primary Completion Date :

Aug 1, 2007

Actual Study Completion Date :

Aug 1, 2007

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

cell-free viral load and/or cell-associated proviral load in breast milk [Delivery, 3 months, and 6 months after delivery]
concentration of vitamins A, B12, and E in breast milk [Delivery, 3 months, and 6 months post-delivery]
subclinical mastitis [Delivery, 3 months, and 6 months after delivery]

Secondary Outcome Measures

post-natal mother-to-child transmission of HIV [Delivery, 3 months, and 6 months post-delivery]
infant mortality and morbidity from diarrhea [Delivery, 3 months and 6 months after delivery]
a.) CCR5 expression in differentiating monocytes and differentiated monocyte-derived macrophages [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. [N/A (in vitro experiment)]