Trial record 1 of 29 for:
" June 30, 2010":" July 30, 2010"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]
Impact of Nutrition Intervention on HIV/AIDS Infected Patients (INI)
This study has been completed.
Sponsor:
Caribbean Health Research Council
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
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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
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 Lentivirus Infections Retroviridae Infections RNA Virus Infections |
Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Slow Virus Diseases Immune System Diseases |
ClinicalTrials.gov processed this record on May 22, 2013