Clinical trial NCT01461863: DarDar Nutrition Study in HIV Breastfeeding Women
Official title: Effects of Protein-calorie Supplementation on HIV Disease in Breastfeeding Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Birth Weight
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: Muhimbili University of Health and Allied Sciences
First posted: 2011-10-28
Enrollment: 96
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Infant Weight
timeFrame: 3 months
Secondary outcomes:
measure: Maternal BMI at 9 Months
timeFrame: 9 months
Other outcomes:
Locations:
city: Dar es Salaam
country: Tanzania
facility: Muhimbili University of Health and Allied Sciences
Study officials:
affiliation: Dartmouth-Hitchcock Medical Center
name: C. Fordham von Reyn, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Magohe A, Mackenzie T, Kimario J, Lukmanji Z, Hendricks K, Koethe J, Neke NM, Tvaroha S, Connor R, Waddell R, Maro I, Matee M, Pallangyo K, Bakari M, von Reyn CF; DarDar-2 Study Team. Pre- and post-natal macronutrient supplementation for HIV-positive women in Tanzania: Effects on infant birth weight and HIV transmission. PLoS One. 2018 Oct 11;13(10):e0201038. doi: 10.1371/journal.pone.0201038. eCollection 2018.