Impact of Nutrition Intervention on HIV/AIDS Infected Patients

NCT01171495 | Completed Phase 3 DMC

• 1 other identifier: CHRC 51016
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

HIV/AIDS; Nutrition Therapy; Dietary Supplement; Antioxidant; Immunity; CD4 count; Anthropometry; Body Mass Index

Outcome Measures

Primary Outcomes (1)

• Effects of nutritional intervention on anthropometry in HIV infected individuals.

  Body Mass Index

  6 months

Secondary Outcomes (1)

• Effects of nutritional intervention on the clinical and immune status in HIV infected individuals.

  6 months

Study Arms (2)

Ensure Plus + Multivitamin/Counselling

EXPERIMENTAL

Dietary Supplement: Theragran-M; Ensure Plus

Multivitamin/Counselling

ACTIVE COMPARATOR

Dietary Supplement: Theragran-M

Interventions

Theragran-M; Ensure Plus DIETARY_SUPPLEMENT

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.

Ensure Plus + Multivitamin/Counselling

Theragran-M DIETARY_SUPPLEMENT

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

Multivitamin/Counselling

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Caribbean Health Research Council: lead
• The University of The West Indies: collaborator

Study Sites (1)

Comprehensive Health Centre

Kingston, Jamaica

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

Theragran-M

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Sharon M Dawson, MSc

  University of the West Indies, Mona ,Jamaica, West Indies

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 27, 2010
• First Posted: July 28, 2010
• Study Start: April 1, 2008
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: July 28, 2010

Record last verified: 2010-02

Locations

JA (1)