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Impact of Nutrition Intervention on HIV/AIDS Infected Patients (INI)

Primary Purpose

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

Status
Completed
Phase
Phase 3
Locations
Jamaica
Study Type
Interventional
Intervention
Theragran-M; Ensure Plus
Theragran-M
Sponsored by
Caribbean Health Research Council
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Human Immunodeficiency Virus (HIV) focused on measuring HIV/AIDS, Nutrition Therapy, Dietary Supplement, Antioxidant, Immunity, CD4 count, Anthropometry, Body Mass Index

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Comprehensive Health Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ensure Plus + Multivitamin/Counselling

Multivitamin/Counselling

Arm Description

Outcomes

Primary Outcome Measures

Effects of nutritional intervention on anthropometry in HIV infected individuals.
Body Mass Index

Secondary Outcome Measures

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

Full Information

First Posted
July 27, 2010
Last Updated
July 27, 2010
Sponsor
Caribbean Health Research Council
Collaborators
The University of The West Indies
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1. Study Identification

Unique Protocol Identification Number
NCT01171495
Brief Title
Impact of Nutrition Intervention on HIV/AIDS Infected Patients
Acronym
INI
Official Title
Phase 3 Study That Assesses the Impact of a Nutrition Intervention on HIV/AIDS Infected Patients: Kingston, Jamaica
Study Type
Interventional

2. Study Status

Record Verification Date
February 2010
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
August 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Caribbean Health Research Council
Collaborators
The University of The West Indies

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Immunodeficiency Virus (HIV), Acquired Immune Deficiency Syndrome (AIDS)
Keywords
HIV/AIDS, Nutrition Therapy, Dietary Supplement, Antioxidant, Immunity, CD4 count, Anthropometry, Body Mass Index

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
121 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ensure Plus + Multivitamin/Counselling
Arm Type
Experimental
Arm Title
Multivitamin/Counselling
Arm Type
Active Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Theragran-M; Ensure Plus
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Theragran-M
Intervention Description
Theragran-M: One tablet daily for 6-months. Nutritional counselling: at baseline and at monthly follow-up visits.
Primary Outcome Measure Information:
Title
Effects of nutritional intervention on anthropometry in HIV infected individuals.
Description
Body Mass Index
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Effects of nutritional intervention on the clinical and immune status in HIV infected individuals.
Description
Immune status (CD4 cell count, total lymphocyte count), antioxidant status.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sharon M Dawson, MSc
Organizational Affiliation
University of the West Indies, Mona ,Jamaica, West Indies
Official's Role
Principal Investigator
Facility Information:
Facility Name
Comprehensive Health Centre
City
Kingston
Country
Jamaica

12. IPD Sharing Statement

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Impact of Nutrition Intervention on HIV/AIDS Infected Patients

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