DarDar Nutrition Study in HIV Breastfeeding Women
DarDar2B
Effects of Protein-calorie Supplementation on HIV Disease in Breastfeeding Women
2 other identifiers
interventional
96
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2011
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2011
CompletedFirst Submitted
Initial submission to the registry
October 13, 2011
CompletedFirst Posted
Study publicly available on registry
October 28, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedResults Posted
Study results publicly available
August 14, 2018
CompletedAugust 14, 2018
July 1, 2018
2.2 years
October 13, 2011
April 30, 2018
July 17, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Infant Weight
Infant weight at 3 months
3 months
Secondary Outcomes (1)
Maternal BMI at 9 Months
9 months
Study Arms (2)
protein calorie supplement
ACTIVE COMPARATOR250 gm daily of specially designed porridge plus standard multivitamin
Multivitamin
PLACEBO COMPARATORStandard multivitamin control
Interventions
250 gm of fortified flour to make porridge containing 1062 kcal and 42 gm protein
Eligibility Criteria
You may qualify if:
- HIV+ women
- nd trimester of pregnancy
- Residency in Dar for duration of breastfeeding
- Plan to exclusively breastfeed
You may not qualify if:
- High risk pregnancy (e.g., diabetes, pre-eclampsia)
- Women with allergy to components of PCS
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Muhimbili University of Health and Allied Sciences
Dar es Salaam, Tanzania
Related Publications (1)
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.
PMID: 30307945DERIVED
MeSH Terms
Interventions
Results Point of Contact
- Title
- Dr. Charles Fordham von Reyn
- Organization
- Dartmouth-Hitchcock
Study Officials
- PRINCIPAL INVESTIGATOR
C. Fordham von Reyn, MD
Dartmouth-Hitchcock Medical Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Medicine
Study Record Dates
First Submitted
October 13, 2011
First Posted
October 28, 2011
Study Start
October 1, 2011
Primary Completion
December 1, 2013
Study Completion
December 1, 2013
Last Updated
August 14, 2018
Results First Posted
August 14, 2018
Record last verified: 2018-07