DarDar Nutrition Study in HIV Breastfeeding Women

Low Birth Weight Clinical Trial

— DarDar2B  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01461863
• Other study ID #: R01HD057614-03
• Secondary ID: R01HD057614
• Status: Completed
• Phase: N/A
• Start date: October 2011
• Est. completion date: December 2013

Study information

• Verified date: July 2018
• Source: Dartmouth-Hitchcock Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Birth Weight
• Low Birth Weight

Intervention

Dietary Supplement:
• Porridge protein calorie supplement
250 gm of fortified flour to make porridge containing 1062 kcal and 42 gm protein
• multivitamin
Standard multivitamin

Locations

Country	Name	City	State
Tanzania	Muhimbili University of Health and Allied Sciences	Dar es Salaam

Sponsors (3)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Muhimbili University of Health and Allied Sciences

Country where clinical trial is conducted

Tanzania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Infant Weight	Infant weight at 3 months	3 months
Secondary	Maternal BMI at 9 Months	Maternal BMI at 9 months	9 months