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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 11 May 2015
Main ID:  NCT02433743
Date of registration: 18/04/2015
Prospective Registration: No
Primary sponsor: Cheikh Anta Diop University, Senegal
Public title: Impact of RUTF on Body Composition, Anemia and Zinc Status of PLWHA PLWHA
Scientific title: Daily Consumption of Ready-to-use Peanut-based Therapeutic Food Increased Fat Free Mass, Improved Anemia Status But Has no Impact on Zinc Status of People Living With HIV/AIDS (PLWHA)
Date of first enrolment: October 2011
Target sample size: 65
Recruitment status: Completed
URL:  http://clinicaltrials.gov/show/NCT02433743
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care  
Phase:  N/A
Countries of recruitment
Senegal
Contacts
Name:     Salimata Wade, Professor
Address: 
Telephone:
Email:
Affiliation:  Université Cheikh Anta Diop de Dakar
Key inclusion & exclusion criteria

Inclusion Criteria:

- HIV/AIDS men and women

- at any WHO stages of HIV disease,

- under ART treatment or not,

- without psychiatric illness and not diabetic

Exclusion Criteria:

- confirmed HIV-negative,

- long term physical disability

- inability to eat



Age minimum: 18 Years
Age maximum: 78 Years
Gender: Both
Health Condition(s) or Problem(s) studied
HIV-infection/Aids
Malnutrition
Intervention(s)
Dietary Supplement: Ready-to-use therapeutic food (RUTF)
Primary Outcome(s)
Change from baseline in body composition at 9 weeks [Time Frame: 9 weeks]
Secondary Outcome(s)
Change from baseline on plasma zinc concentration at 9 weeks [Time Frame: 9 weeks]
Change from baseline on anemia at 9 weeks [Time Frame: 9 weeks]
Change from baseline on anemia at 3 weeks [Time Frame: 3 weeks]
Change from baseline on plasma zinc concentration at 3 weeks [Time Frame: 3 weeks]
Secondary ID(s)
UCheikhAntaDiop
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
UNICEF
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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