- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01171495
Impact of Nutrition Intervention on HIV/AIDS Infected Patients (INI)
Phase 3 Study That Assesses the Impact of a Nutrition Intervention on HIV/AIDS Infected Patients: Kingston, Jamaica
Study Overview
Status
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
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
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Kingston, Jamaica
- Comprehensive Health Centre
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
|
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
|
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
Collaborators
Investigators
- Principal Investigator: Sharon M Dawson, MSc, University of the West Indies, Mona ,Jamaica, West Indies
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immune System Diseases
- Slow Virus Diseases
- HIV Infections
- Acquired Immunodeficiency Syndrome
- Immunologic Deficiency Syndromes
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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