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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Low Birth Weight | Dietary Supplement: Porridge protein calorie supplement Dietary Supplement: multivitamin | Phase 2 Phase 3 |
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 |
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
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Dietary Supplement: multivitamin
Standard multivitamin
Other Name: Darvite
|
- weight [ Time Frame: 3 months ]Infant weight at 3 months
- BMI at 9 months [ Time Frame: 9 months ]BMI at 9 months

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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

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
Tanzania | |
Muhimbili University of Health and Allied Sciences | |
Dar es Salaam, Tanzania |
Principal Investigator: | C. Fordham von Reyn, MD | Dartmouth-Hitchcock Medical Center |
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 |