Effects of a Protein Calorie Supplement in HIV-infected Women With Tuberculosis (DarDar)
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ClinicalTrials.gov Identifier: NCT01635153 |
Recruitment Status
:
Completed
First Posted
: July 9, 2012
Last Update Posted
: February 10, 2015
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Tuberculosis | Dietary Supplement: Protein calorie supplement Dietary Supplement: Micronutrient | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 151 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Randomized Controlled Trial of a Protein-calorie Supplement for HIV-infected Women With Tuberculosis |
Study Start Date : | May 2012 |
Actual Primary Completion Date : | July 2014 |
Actual Study Completion Date : | July 2014 |
Arm | Intervention/treatment |
---|---|
Active Comparator: Protein calorie supplement plus micronutrient |
Dietary Supplement: Protein calorie supplement
Fortified porridge with 1062 kcal and 40 gm protein
Other Name: Dar-uji
|
Placebo Comparator: Micronutrient alone |
Dietary Supplement: Micronutrient
Dar-vite Multivitamin
|
- Change in CD4 count [ Time Frame: Baseline to 8 months ]We will calculate change in CD4 count from start of ART until 6 mos on ART
- BMI at 6 months [ Time Frame: baseline to 6 months ]BMI will be compared between the two treatment groups
- Proportion of subjects who achieve 100 cell increase in CD4 [ Time Frame: baseline to 8 months ]% of subjects in 2 treatment groups who achieve 100 cell increase in CD4 will be compared

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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:
- female,
- HIV,
- age > 18,
- CD4 > 50,
- BMI>16
- new TB diagnosis,
- not on anti-retroviral therapy,
- residence in Dar es Salaam
Exclusion Criteria:
- current anti-retroviral therapy,
- serious co-morbidities

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): NCT01635153
Tanzania | |
Infectious Disease Centre | |
Dar es Salaam, Tanzania |
Principal Investigator: | Charles F. von Reyn, MD | Dartmouth College | |
Study Director: | Nyasule Majura-Neke, MD | Muhimbili University of Health and Allied Sciences |
Responsible Party: | Dartmouth-Hitchcock Medical Center |
ClinicalTrials.gov Identifier: | NCT01635153 History of Changes |
Other Study ID Numbers: |
DarDar 2-C CPHS 21592 RO1 503498 ( Other Identifier: NIH ) |
First Posted: | July 9, 2012 Key Record Dates |
Last Update Posted: | February 10, 2015 |
Last Verified: | February 2015 |
Keywords provided by Dartmouth-Hitchcock Medical Center:
HIV Tuberculosis Nutrition |
Additional relevant MeSH terms:
Tuberculosis Mycobacterium Infections Actinomycetales Infections Gram-Positive Bacterial Infections Bacterial Infections |
Micronutrients Trace Elements Growth Substances Physiological Effects of Drugs |