DarDar Nutrition Study in HIV Breastfeeding Women (DarDar2B)

Dartmouth Health

Status: Completed

Conditions: Low Birth Weight

Treatments: Dietary Supplement: multivitamin; Dietary Supplement: Porridge protein calorie supplement

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01461863

R01HD057614 (U.S. NIH Grant/Contract)

R01HD057614-03

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 96 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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96 participants in 2 patient groups, including a placebo group

protein calorie supplement

Active Comparator group

Description:

250 gm daily of specially designed porridge plus standard multivitamin

Treatment:

Dietary Supplement: Porridge protein calorie supplement

Multivitamin

Placebo Comparator group

Description:

Standard multivitamin control

Treatment:

Dietary Supplement: multivitamin