Impact of Nutrition Intervention on HIV/AIDS Infected Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

121 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2009-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Ensure Plus + Multivitamin/Counselling

Group Type EXPERIMENTAL

Theragran-M; Ensure Plus

Intervention Type DIETARY_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.

Multivitamin/Counselling

Group Type ACTIVE_COMPARATOR

Theragran-M

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

Theragran-M

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No