NCT01171495

Impact of Nutrition Intervention on HIV/AIDS Infected Patients

Phase 3 Study That Assesses the Impact of a Nutrition Intervention on HIV/AIDS Infected Patients: Kingston, Jamaica

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 121 (actual)
• Sponsor: Caribbean Health Research Council · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

Intervention 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.

Detailed description

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.

Conditions

• Human Immunodeficiency Virus (HIV)
• Acquired Immune Deficiency Syndrome (AIDS)

Interventions

Type	Name	Description
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.
DIETARY_SUPPLEMENT	Theragran-M	Theragran-M: One tablet daily for 6-months. Nutritional counselling: at baseline and at monthly follow-up visits.

Timeline

• Start date: 2008-04-01
• Primary completion: 2009-08-01
• Completion: 2009-08-01
• First posted: 2010-07-28
• Last updated: 2010-07-28

Locations

1 site across 1 country: Jamaica