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DarDar Nutrition Study in HIV Breastfeeding Women (DarDar2B)

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ClinicalTrials.gov Identifier: NCT01461863
Recruitment Status : Completed
First Posted : October 28, 2011
Last Update Posted : September 29, 2014
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

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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 or disease Intervention/treatment Phase
Low Birth Weight Dietary Supplement: Porridge protein calorie supplement Dietary Supplement: multivitamin Phase 2 Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 96 participants
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
Study Start Date : October 2011
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

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U.S. FDA Resources

Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
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Primary Outcome Measures :
  1. weight [ Time Frame: 3 months ]
    Infant weight at 3 months


Secondary Outcome Measures :
  1. BMI at 9 months [ Time Frame: 9 months ]
    BMI at 9 months


Eligibility Criteria
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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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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 )
First Posted: October 28, 2011    Key Record Dates
Last Update Posted: September 29, 2014
Last Verified: September 2014

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