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

This study has been completed.
Sponsor:
Collaborator:
The University of The West Indies
Information provided by:
Caribbean Health Research Council
ClinicalTrials.gov Identifier:
NCT01171495
First received: July 27, 2010
Last updated: NA
Last verified: February 2010
History: No changes posted
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]
    Body Mass Index


Secondary Outcome Measures:
  • Effects of nutritional intervention on the clinical and immune status in HIV infected individuals. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: July 27, 2010
Last Updated: July 27, 2010
Health Authority: Jamaica: Ministry of Health

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

ClinicalTrials.gov processed this record on October 23, 2014