Impact of Nutrition Intervention on HIV/AIDS Infected Patients (INI)

Caribbean Health Research Council

Status and phase

Completed

Phase 3

Conditions

Acquired Immune Deficiency Syndrome (AIDS)

Human Immunodeficiency Virus (HIV)

Treatments

Dietary Supplement: Theragran-M; Ensure Plus

Dietary Supplement: Theragran-M

Study type

Interventional

Funder types

Other

Identifiers

NCT01171495

CHRC 51016

Details and patient eligibility

About

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.

Full 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.

Enrollment

121 patients

Sex

All

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

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.