DarDar Nutrition Study in HIV Breastfeeding Women (DarDar2B)

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

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.

Study Overview

• Status: Completed
• Conditions: Low Birth Weight
• Intervention / Treatment: Dietary supplement: Porridge protein calorie supplement; Dietary supplement: multivitamin

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.

• Study Type: Interventional
• Enrollment (Actual): 96
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Tanzania
  • Dar es Salaam, Tanzania
    • Muhimbili University of Health and Allied Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Dartmouth-Hitchcock Medical Center
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); Muhimbili University of Health and Allied Sciences
• Investigators: Principal Investigator: C. Fordham von Reyn, MD, Dartmouth-Hitchcock Medical Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: October 13, 2011
• First Submitted That Met QC Criteria: October 26, 2011
• First Posted (Estimate): October 28, 2011

Study Record Updates

• Last Update Posted (Actual): August 14, 2018
• Last Update Submitted That Met QC Criteria: July 17, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Birth Weight
• Other Study ID Numbers: R01HD057614-03 (U.S. NIH Grant/Contract); R01HD057614 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No