NCT01461863

DarDar Nutrition Study in HIV Breastfeeding Women

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 96 (actual)
• Sponsor: Dartmouth-Hitchcock Medical Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Low Birth Weight

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Porridge protein calorie supplement	250 gm of fortified flour to make porridge containing 1062 kcal and 42 gm protein
DIETARY_SUPPLEMENT	multivitamin	Standard multivitamin

Timeline

• Start date: 2011-10-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2011-10-28
• Last updated: 2018-08-14
• Results posted: 2018-08-14

Locations

1 site across 1 country: Tanzania