Impact of Nutrition Intervention on HIV/AIDS Infected Patients (INI)
|Human Immunodeficiency Virus (HIV) Acquired Immune Deficiency Syndrome (AIDS)||Dietary Supplement: Theragran-M; Ensure Plus Dietary Supplement: Theragran-M||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
|Official Title:||Phase 3 Study That Assesses the Impact of a Nutrition Intervention on HIV/AIDS Infected Patients: Kingston, Jamaica|
- Effects of nutritional intervention on anthropometry in HIV infected individuals. [ Time Frame: 6 months ]Body Mass Index
- Effects of nutritional intervention on the clinical and immune status in HIV infected individuals. [ Time Frame: 6 months ]Immune status (CD4 cell count, total lymphocyte count), antioxidant status.
|Study Start Date:||April 2008|
|Study Completion Date:||August 2009|
|Primary Completion Date:||August 2009 (Final data collection date for primary outcome measure)|
|Experimental: Ensure Plus + Multivitamin/Counselling||
Dietary Supplement: Theragran-M; Ensure Plus
Theragran-M: One tablet daily for 6-months. Ensure Plus: One 8 fl.oz. bottle daily for 6-months. Nutritional counselling: at baseline, and at monthly follow-up visits.
|Active Comparator: Multivitamin/Counselling||
Dietary Supplement: Theragran-M
Theragran-M: One tablet daily for 6-months. Nutritional counselling: at baseline and at monthly follow-up visits.
To investigate the efficacy of a nutritional supplement among ARV-naïve, asymptomatic HIV positive patients with a CD4 count in the range 300-550 cells/ul.
A total of 120 participants will be stratified by age and gender and randomly assigned to two treatment arms. Sixty (60) participants will be assigned to receive dietary counselling and a multivitamin/mineral supplement, with sixty (60) additionally receiving an oral Medical Nutritional Supplement (MNS).
Participants will be followed for six months post-randomization: at baseline, 3 months and 6 months. The principal outcome measure is Body Mass Index, used as a proxy for 'nutritional status'. Secondary outcome measures include immune status and antioxidant status.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01171495
|Comprehensive Health Centre|
|Principal Investigator:||Sharon M Dawson, MSc||University of the West Indies, Mona ,Jamaica, West Indies|