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

July 27, 2010 updated by: Caribbean Health Research Council

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

121

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Jamaica
      • Kingston, Jamaica
        • Comprehensive Health Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ensure Plus + Multivitamin/Counselling
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.
Active Comparator: Multivitamin/Counselling
Dietary supplement: Theragran-M
Theragran-M: One tablet daily for 6-months. Nutritional counselling: at baseline and at monthly follow-up visits.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effects of nutritional intervention on anthropometry in HIV infected individuals.
Time Frame: 6 months
Body Mass Index
6 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Caribbean Health Research Council

Collaborators

The University of The West Indies

Investigators

  • Principal Investigator: Sharon M Dawson, MSc, University of the West Indies, Mona ,Jamaica, West Indies

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Actual)

August 1, 2009

Study Completion (Actual)

August 1, 2009

Study Registration Dates

First Submitted

July 27, 2010

First Submitted That Met QC Criteria

July 27, 2010

First Posted (Estimate)

July 28, 2010

Study Record Updates

Last Update Posted (Estimate)

July 28, 2010

Last Update Submitted That Met QC Criteria

July 27, 2010

Last Verified

February 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHRC 51016

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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