Vitamins, Breastmilk HIV Shedding, and Child Health

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

771 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-09-30

Study Completion Date

2007-08-31

Brief Summary

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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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Detailed Description

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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

Conditions

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Maternal and Child Health Outcomes

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Vitamin A

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

Vitamin A alone

Intervention Type DIETARY_SUPPLEMENT

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.

Multivitamins excluding vitamin A

Intervention Type 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

Intervention Type 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

Intervention Type OTHER

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

Vitamin A alone

Intervention Type DIETARY_SUPPLEMENT

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

Multivitamins excluding vitamin A

Intervention Type 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

Intervention Type 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

No Multivitamins

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

Vitamin A alone

Intervention Type DIETARY_SUPPLEMENT

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

Placebo

Intervention Type OTHER

Placebo pill taken orally once per day during pregnancy and lactation

Interventions

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Vitamin A alone

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

Intervention Type 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

Intervention Type 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

Intervention Type DIETARY_SUPPLEMENT