DarDar Nutrition Study in HIV Breastfeeding Women

Study Overview
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Brief Summary
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This study being conducted in Dar es Salaam, Tanzania, to determine if a protein-calorie supplementation (PCS) and micronutrient supplement (MNS) will have an impact on health outcomes for HIV-infected pregnant women and their infants.

Detailed Description
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In resource poor regions of the world where HIV is endemic, especially countries in sub-Saharan Africa, nutrition plays a critical role in HIV disease. Nutrition affects the health of HIV-infected women and children, and may influence the risk of mother to infant transmission of HIV through breast milk. Nutrition influences the risk of tuberculosis (TB) and TB disease severity. Existing research has focused on the role of micronutrients in HIV disease outcomes but has not addressed the role of protein calorie supplementation (PCS) in subpopulations of patients with HIV disease at high risk, specifically, HIV-infected women who are either breast feeding or have active TB. Our hypotheses are that administration of a culturally acceptable PCS is a practical, sustainable and effective strategy to: 1) decrease HIV viral load in plasma and breast milk of breast feeding women, enhance passively transferred immune mediators in breast milk, and improve HIV outcomes in women and their breast-fed infants and, 2) decrease HIV viral load, enhance TB-specific T cell immunity, and improve outcomes in women with HIV and active TB.

Official Title
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Effects of Protein-calorie Supplementation on HIV Disease in Breastfeeding Women

Conditions
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Low Birth Weight

Intervention / Treatment
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* Dietary Supplement: Porridge protein calorie supplement
* Dietary Supplement: multivitamin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: HIV+ women 2nd trimester of pregnancy Residency in Dar for duration of breastfeeding Plan to exclusively breastfeed Exclusion Criteria: High risk pregnancy (e.g., diabetes, pre-eclampsia) Women with allergy to components of PCS

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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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: protein calorie supplement<br>250 gm daily of specially designed porridge plus standard multivitamin | Dietary Supplement: Porridge protein calorie supplement<br>* 250 gm of fortified flour to make porridge containing 1062 kcal and 42 gm protein<br>* Other names: Dar-uji;|
| Placebo Comparator: Multivitamin<br>Standard multivitamin control | Dietary Supplement: multivitamin<br>* Standard multivitamin<br>* Other names: Darvite;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infant Weight | Infant weight at 3 months | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal BMI at 9 Months | Maternal BMI at 9 months | 9 months |