Impact of Nutrition Intervention on HIV/AIDS Infected Patients

Phase 3

Completed

• Conditions: Human Immunodeficiency Virus (HIV); Acquired Immune Deficiency Syndrome (AIDS)
• Interventions: Dietary Supplement: Theragran-M; Ensure Plus; Dietary Supplement: Theragran-M

• Registration Number: NCT01171495
• Lead Sponsor: Caribbean Health Research Council

Brief 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.

Study Timeline

• Study Start: 2008-04
• Primary Completion: 2009-08
• Study Completion: 2009-08
• Status Verified: 2010-02
• Study First Submitted: 2010-07-27
• Study First Submitted QC: 2010-07-27
• Last Update Submitted: 2010-07-27
• Study First Posted: 2010-07-28
• Last Update Posted: 2010-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 121

Inclusion Criteria

• HIV positive individuals in the age range 18 to 50 years.
• Individuals whose CD4 count was between 300-550 cells/uL.
• Individuals who met the study criteria and were interested in being enrolled.
• Individuals not on ARV therapy.
• Women who were not pregnant.

Exclusion Criteria

• On the clinician's advice, individuals could be excluded from enrollment.
• Individuals who were unable to carry out the study intervention e.g. homeless, impaired mental state etc.
• Individuals who were unlikely to complete follow-up based on pre-enrolment assessment.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ensure Plus + Multivitamin/Counselling	Theragran-M; Ensure Plus	-
Multivitamin/Counselling	Theragran-M	-

Primary Outcome Measures

Name	Time	Method
Effects of nutritional intervention on anthropometry in HIV infected individuals.	6 months	Body Mass Index

Secondary Outcome Measures

Name	Time	Method
Effects of nutritional intervention on the clinical and immune status in HIV infected individuals.	6 months	Immune status (CD4 cell count, total lymphocyte count), antioxidant status.

Trial Locations

Locations (1)

Comprehensive Health Centre; 🇯🇲 Kingston, Jamaica