DarDar Nutrition Study in HIV Breastfeeding Women (DarDar2B)

This study has been completed.

Sponsor:

Collaborators:

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Muhimbili University of Health and Allied Sciences

Information provided by (Responsible Party):

Dartmouth-Hitchcock Medical Center

ClinicalTrials.gov Identifier:

NCT01461863

First received: October 13, 2011

Last updated: September 26, 2014

Last verified: September 2014

History of Changes

Purpose

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.

Condition	Intervention	Phase
Low Birth Weight	Dietary Supplement: Porridge protein calorie supplement Dietary Supplement: multivitamin	Phase 2 Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment
Official Title:	Effects of Protein-calorie Supplementation on HIV Disease in Breastfeeding Women

Resource links provided by NLM:

MedlinePlus related topics: Birth Weight Breastfeeding HIV/AIDS

Drug Information available for: Infuvite Adult Infuvite Pediatric

U.S. FDA Resources

Further study details as provided by Dartmouth-Hitchcock Medical Center:

Primary Outcome Measures:

weight [ Time Frame: 3 months ]
Infant weight at 3 months

Secondary Outcome Measures:

BMI at 9 months [ Time Frame: 9 months ]
BMI at 9 months


Enrollment:	96
Study Start Date:	October 2011
Study Completion Date:	December 2013
Primary Completion Date:	December 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 Name: Dar-uji
Placebo Comparator: Multivitamin Standard multivitamin control	Dietary Supplement: multivitamin Standard multivitamin Other Name: Darvite

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


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01461863

Locations


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

Sponsors and Collaborators

Dartmouth-Hitchcock Medical Center

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

More Information


Responsible Party:	Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier:	NCT01461863 History of Changes
Other Study ID Numbers:	R01HD057614-03 ( U.S. NIH Grant/Contract ) R01HD057614 ( U.S. NIH Grant/Contract )
Study First Received:	October 13, 2011
Last Updated:	September 26, 2014

Additional relevant MeSH terms:


Birth Weight Body Weight Signs and Symptoms

ClinicalTrials.gov processed this record on September 21, 2017

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