Impact of Nutrition Intervention on HIV/AIDS Infected Patients (INI)
|ClinicalTrials.gov Identifier: NCT01171495|
Recruitment Status : Completed
First Posted : July 28, 2010
Last Update Posted : July 28, 2010
|Condition or disease||Intervention/treatment||Phase|
|Human Immunodeficiency Virus (HIV) Acquired Immune Deficiency Syndrome (AIDS)||Dietary Supplement: Theragran-M; Ensure Plus Dietary Supplement: Theragran-M||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||121 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 3 Study That Assesses the Impact of a Nutrition Intervention on HIV/AIDS Infected Patients: Kingston, Jamaica|
|Study Start Date :||April 2008|
|Actual Primary Completion Date :||August 2009|
|Actual Study Completion Date :||August 2009|
|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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01171495
|Comprehensive Health Centre|
|Principal Investigator:||Sharon M Dawson, MSc||University of the West Indies, Mona ,Jamaica, West Indies|