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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
July 27, 2010
July 28, 2010
July 28, 2010
April 2008
August 2009   (Final data collection date for primary outcome measure)
Effects of nutritional intervention on anthropometry in HIV infected individuals. [ Time Frame: 6 months ]
Body Mass Index
Same as current
No Changes Posted
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.
Same as current
Not Provided
Not Provided
 
Impact of Nutrition Intervention on HIV/AIDS Infected Patients
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.

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.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
  • Human Immunodeficiency Virus (HIV)
  • Acquired Immune Deficiency Syndrome (AIDS)
  • 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.
  • Dietary Supplement: Theragran-M
    Theragran-M: One tablet daily for 6-months. Nutritional counselling: at baseline and at monthly follow-up visits.
  • Experimental: Ensure Plus + Multivitamin/Counselling
    Intervention: Dietary Supplement: Theragran-M; Ensure Plus
  • Active Comparator: Multivitamin/Counselling
    Intervention: Dietary Supplement: Theragran-M
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
121
August 2009
August 2009   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 50 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Jamaica
 
 
NCT01171495
CHRC 51016
Yes
Not Provided
Not Provided
Sharon Dawson, Ministry of Health,Kingston, Jamaica and The University of the West Indies, Mona, Jamaica
Caribbean Health Research Council
The University of The West Indies
Principal Investigator: Sharon M Dawson, MSc University of the West Indies, Mona ,Jamaica, West Indies
Caribbean Health Research Council
February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP