Vitamins, Breastmilk HIV Shedding, and Child Health

Study Overview
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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.

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

Official Title
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Vitamins, Breastmilk HIV Shedding, and Child Health

Conditions
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Maternal and Child Health Outcomes

Intervention / Treatment
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* Dietary Supplement: Vitamin A alone
* Dietary Supplement: Multivitamins excluding vitamin A
* Dietary Supplement: multivitamins including vitamin A
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, Breastfeeding, Vitamins, Tanzania, Children