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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01171495
First Posted: July 28, 2010
Last Update Posted: July 28, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
The University of The West Indies
Information provided by:
Caribbean Health Research Council
  Purpose
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.

Condition Intervention Phase
Human Immunodeficiency Virus (HIV) Acquired Immune Deficiency Syndrome (AIDS) Dietary Supplement: Theragran-M; Ensure Plus Dietary Supplement: Theragran-M Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Phase 3 Study That Assesses the Impact of a Nutrition Intervention on HIV/AIDS Infected Patients: Kingston, Jamaica

Resource links provided by NLM:


Further study details as provided by Caribbean Health Research Council:

Primary Outcome Measures:
  • Effects of nutritional intervention on anthropometry in HIV infected individuals. [ Time Frame: 6 months ]
    Body Mass Index


Secondary Outcome Measures:
  • 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.


Enrollment: 121
Study Start Date: April 2008
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01171495


Locations
Jamaica
Comprehensive Health Centre
Kingston, Jamaica
Sponsors and Collaborators
Caribbean Health Research Council
The University of The West Indies
Investigators
Principal Investigator: Sharon M Dawson, MSc University of the West Indies, Mona ,Jamaica, West Indies
  More Information

Responsible Party: Sharon Dawson, Ministry of Health,Kingston, Jamaica and The University of the West Indies, Mona, Jamaica
ClinicalTrials.gov Identifier: NCT01171495     History of Changes
Other Study ID Numbers: CHRC 51016
First Submitted: July 27, 2010
First Posted: July 28, 2010
Last Update Posted: July 28, 2010
Last Verified: February 2010

Keywords provided by Caribbean Health Research Council:
HIV/AIDS
Nutrition Therapy
Dietary Supplement
Antioxidant
Immunity
CD4 count
Anthropometry
Body Mass Index

Additional relevant MeSH terms:
Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases