Impact of Nutrition Intervention on HIV/AIDS Infected Patients

Human Immunodeficiency Virus (HIV) Clinical Trial

— INI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01171495
• Other study ID #: CHRC 51016
• Status: Completed
• Phase: Phase 3
• First received: July 27, 2010
• Last updated: July 27, 2010
• Start date: April 2008
• Est. completion date: August 2009

Study information

• Verified date: February 2010
• Source: Caribbean Health Research Council
• Contact: n/a
• Is FDA regulated: No
• Health authority: Jamaica: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
Jamaica	Comprehensive Health Centre	Kingston

Sponsors (2)

Lead Sponsor	Collaborator
Caribbean Health Research Council	The University of The West Indies

Country where clinical trial is conducted

Jamaica, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effects of nutritional intervention on anthropometry in HIV infected individuals.	Body Mass Index	6 months	No
Secondary	Effects of nutritional intervention on the clinical and immune status in HIV infected individuals.	Immune status (CD4 cell count, total lymphocyte count), antioxidant status.	6 months	No