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.
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): NCT01171495
|Comprehensive Health Centre|
|Principal Investigator:||Sharon M Dawson, MSc||University of the West Indies, Mona ,Jamaica, West Indies|