Malnutrition Clinical Trial
— PLWHAOfficial 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)
Verified date | April 2015 |
Source | Cheikh Anta Diop University, Senegal |
Contact | n/a |
Is FDA regulated | No |
Health authority | Senegal: Ministere de la sante |
Study type | Interventional |
A clinical trial was conducted in 65 PLWH randomly allocated to receive standard hospital diet alone (Control group: n=33), or the diet combined with 100 g/day of RUTF (RUTF group: n=32). Individual dietary intakes were measured and compared to the Recommended Dietary Allowances (RDA) for PLWH. Body composition was measured by bio-impedance analysis (BIA), hemoglobin by HemoCue and plasma zinc concentration by atomic absorption spectrometry and adjusted to infection (CRP and α1-AGP). All measures were conducted at baseline, 3 weeks and after 9 weeks home-based follow up.
Status | Completed |
Enrollment | 65 |
Est. completion date | July 2012 |
Est. primary completion date | June 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 78 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
Senegal | University Cheikh Anta Diop | Dakar |
Lead Sponsor | Collaborator |
---|---|
Cheikh Anta Diop University, Senegal | UNICEF |
Senegal,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline in body composition at 9 weeks | Body composition was measured using Bio-impedance analysis method at baseline, and 9 weeks home-based follow-up in both supplemented and control groups | 9 weeks | Yes |
Secondary | Change from baseline on anemia at 3 weeks | Hemoglobin was measured by Hemocue photometer at baseline and 3 week after admission in both supplemented and control groups | 3 weeks | Yes |
Secondary | Change from baseline on anemia at 9 weeks | Hemoglobin was measured by Hemocue photometer at baseline and after 9 weeks home-based follow-up in both supplemented and control groups | 9 weeks | Yes |
Secondary | Change from baseline on plasma zinc concentration at 3 weeks | Plasma zinc concentration was determined by Atomic absorption spectrometry at baseline and 3 weeks after admission in both supplemented and control groups | 3 weeks | Yes |
Secondary | Change from baseline on plasma zinc concentration at 9 weeks | Plasma zinc concentration was determined by Atomic absorption spectrometry at baseline and after 9 weeks home-based follow-up in both supplemented and control groups | 9 weeks | Yes |
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