N/A
N=96
DarDar Nutrition Study in HIV Breastfeeding Women
Low Birth Weight
Bottom Line
View on ClinicalTrials.gov: NCT01461863 ↗Enrolled (actual)
96
Serious AEs
2.1%
Results posted
Aug 2018
Primary outcome: Primary: Infant Weight — 6.92; 7.32 kg
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Porridge protein calorie supplement (Dietary_supplement); multivitamin (Dietary_supplement)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Dartmouth-Hitchcock Medical Center
- Primary completion
- Dec 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Infant Weight |
6.92; 7.32 | — |
| SECONDARY Maternal BMI at 9 Months |
24.3; 23.8 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT01461863). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.