DarDar Nutrition Study in HIV Breastfeeding Women (DarDar2B)

This study has been completed.
Sponsor:
Collaborators:
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

October 13, 2011
September 26, 2014
October 2011
December 2013   (final data collection date for primary outcome measure)
weight [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Infant weight at 3 months
Same as current
Complete list of historical versions of study NCT01461863 on ClinicalTrials.gov Archive Site
BMI at 9 months [ Time Frame: 9 months ] [ Designated as safety issue: No ]
BMI at 9 months
Maternal BMI [ Time Frame: 9 months ] [ Designated as safety issue: No ]
BMI at 9 months
Not Provided
Not Provided
 
DarDar Nutrition Study in HIV Breastfeeding Women
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.

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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Low Birth Weight
  • 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
  • Dietary Supplement: multivitamin
    Standard multivitamin
    Other Name: Darvite
  • Active Comparator: protein calorie supplement
    250 gm daily of specially designed porridge plus standard multivitamin
    Intervention: Dietary Supplement: Porridge protein calorie supplement
  • Placebo Comparator: Multivitamin
    Standard multivitamin control
    Intervention: Dietary Supplement: multivitamin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
96
December 2013
December 2013   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Tanzania
 
NCT01461863
R01HD057614-03, R01HD057614
No
Dartmouth-Hitchcock Medical Center
Dartmouth-Hitchcock Medical Center
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • Muhimbili University of Health and Allied Sciences
Principal Investigator: C. Fordham von Reyn, MD Dartmouth-Hitchcock Medical Center
Dartmouth-Hitchcock Medical Center
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP