Acquired Immune Deficiency Syndrome (AIDS), Human Immunodeficiency Virus (HIV)
Conditions
Keywords
HIV/AIDS, Nutrition Therapy, Dietary Supplement, Antioxidant, Immunity, CD4 count, Anthropometry, Body Mass Index
Brief summary
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.
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.
Interventions
DIETARY_SUPPLEMENTTheragran-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_SUPPLEMENTTheragran-M
Theragran-M: One tablet daily for 6-months. Nutritional counselling: at baseline and at monthly follow-up visits.
Sponsors
The University of The West Indies
Caribbean Health Research Council
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effects of nutritional intervention on anthropometry in HIV infected individuals. | 6 months | Body Mass Index |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effects of nutritional intervention on the clinical and immune status in HIV infected individuals. | 6 months | Immune status (CD4 cell count, total lymphocyte count), antioxidant status. |
Countries
Jamaica
Outcome results
None listed