Text Size

DarDar Nutrition Study in HIV Breastfeeding Women (DarDar2B)

This study is ongoing, but not recruiting participants.
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):
C. Fordham von Reyn, Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier:
NCT01461863
First received: October 13, 2011
Last updated: January 22, 2013
Last verified: January 2013
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effects of Protein-calorie Supplementation on HIV Disease in Breastfeeding Women

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • weight [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Infant weight at 3 months


Secondary Outcome Measures:
  • BMI at 9 months [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    BMI at 9 months


Estimated Enrollment: 96
Study Start Date: October 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: August 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
Genders 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
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

No publications provided

Responsible Party: C. Fordham von Reyn, Professor of Medicine, Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT01461863     History of Changes
Other Study ID Numbers: R01HD057614-03, R01HD057614
Study First Received: October 13, 2011
Last Updated: January 22, 2013
Health Authority: Tanzania: National Institute for Medical Research

Additional relevant MeSH terms:
Birth Weight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 19, 2013