Impact of Nutrition Intervention on HIV/AIDS Infected Patients

Caribbean Health Research Council121 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

121

Conditions

Human Immunodeficiency Virus (HIV)Acquired Immune Deficiency Syndrome (AIDS)

Interventions

Theragran-M; Ensure PlusDIETARY_SUPPLEMENT

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.

Theragran-MDIETARY_SUPPLEMENT

Theragran-M: One tablet daily for 6-months. Nutritional counselling: at baseline and at monthly follow-up visits.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

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.

Locations (1)

Comprehensive Health Centre

Kingston, Jamaica

Outcomes

Primary Outcomes

Effects of nutritional intervention on anthropometry in HIV infected individuals.

Body Mass Index

Time frame: 6 months

Secondary Outcomes

Effects of nutritional intervention on the clinical and immune status in HIV infected individuals.

Immune status (CD4 cell count, total lymphocyte count), antioxidant status.

Time frame: 6 months

Data from ClinicalTrials.gov

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