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DarDar Nutrition Study in HIV Breastfeeding Women (DarDar2B)

Primary Purpose

Low Birth Weight

Status
Completed
Phase
Not Applicable
Locations
Tanzania
Study Type
Interventional
Intervention
Porridge protein calorie supplement
multivitamin
Sponsored by
Dartmouth-Hitchcock Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Birth Weight

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Muhimbili University of Health and Allied Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

protein calorie supplement

Multivitamin

Arm Description

250 gm daily of specially designed porridge plus standard multivitamin

Standard multivitamin control

Outcomes

Primary Outcome Measures

Infant Weight
Infant weight at 3 months

Secondary Outcome Measures

Maternal BMI at 9 Months
Maternal BMI at 9 months

Full Information

First Posted
October 13, 2011
Last Updated
July 17, 2018
Sponsor
Dartmouth-Hitchcock Medical Center
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Muhimbili University of Health and Allied Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01461863
Brief Title
DarDar Nutrition Study in HIV Breastfeeding Women
Acronym
DarDar2B
Official Title
Effects of Protein-calorie Supplementation on HIV Disease in Breastfeeding Women
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dartmouth-Hitchcock Medical Center
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Muhimbili University of Health and Allied Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Birth Weight

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
96 (Actual)

8. Arms, Groups, and Interventions

Arm Title
protein calorie supplement
Arm Type
Active Comparator
Arm Description
250 gm daily of specially designed porridge plus standard multivitamin
Arm Title
Multivitamin
Arm Type
Placebo Comparator
Arm Description
Standard multivitamin control
Intervention Type
Dietary Supplement
Intervention Name(s)
Porridge protein calorie supplement
Other Intervention Name(s)
Dar-uji
Intervention Description
250 gm of fortified flour to make porridge containing 1062 kcal and 42 gm protein
Intervention Type
Dietary Supplement
Intervention Name(s)
multivitamin
Other Intervention Name(s)
Darvite
Intervention Description
Standard multivitamin
Primary Outcome Measure Information:
Title
Infant Weight
Description
Infant weight at 3 months
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Maternal BMI at 9 Months
Description
Maternal BMI at 9 months
Time Frame
9 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
C. Fordham von Reyn, MD
Organizational Affiliation
Dartmouth-Hitchcock Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Muhimbili University of Health and Allied Sciences
City
Dar es Salaam
Country
Tanzania

12. IPD Sharing Statement

Citations:
PubMed Identifier
30307945
Citation
Magohe A, Mackenzie T, Kimario J, Lukmanji Z, Hendricks K, Koethe J, Neke NM, Tvaroha S, Connor R, Waddell R, Maro I, Matee M, Pallangyo K, Bakari M, von Reyn CF; DarDar-2 Study Team. Pre- and post-natal macronutrient supplementation for HIV-positive women in Tanzania: Effects on infant birth weight and HIV transmission. PLoS One. 2018 Oct 11;13(10):e0201038. doi: 10.1371/journal.pone.0201038. eCollection 2018.
Results Reference
derived

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DarDar Nutrition Study in HIV Breastfeeding Women

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