Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting
Text Size

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
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
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)
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
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  R01HD057614 
Study First Received: October 13, 2011
Last Updated: September 26, 2014
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 September 30, 2016