Zinc Supplementation Effect on Immune Recovery in HIV Patients

CES University

Status: Unknown

Conditions: AIDS; Viral Replication; HIV; Immunological Deficiency; Inadequate Immune Recovery

Treatments: Dietary Supplement: Zinc supplementation; Dietary Supplement: Placebo supplementation

Study type: Interventional

Funder types: Other

Identifiers

NCT02162797

SUPL002

Details and patient eligibility

About

INTRODUCTION:

An adequate zinc supplementation is essential for a good immunological function. However, zinc deficiency is seen in more than 50% of adults infected with HIV. The safety and efficiency of zinc supplements in the progression of HIV is evaluated in the short-term.

HYPOTHESIS

Null hypothesis: Zinc supplementation does not improve the immunological recovery of HIV patients after three months of daily consumption.

Alternate hypothesis: Zinc supplementation improves the immunological recovery of HIV patients after three months of daily consumption

Full description

GOAL:

To assess the effect of zinc supplementation in the natural history of HIV, emphasizing on the immunological recovery of patients in a health care provider program in Medellín in 2012.

METHODS:

A prospective, randomized, double-blind, controlled clinical trial will be conducted. The selected group will consist of male and female patients over 18 years of age, who comply with the inclusion criteria, with digital clinical history, in an HIV/AIDS program of a health care provider in Medellín. They will receive zinc supplements for 3 months. A comparison will be made between the immunological recovery among those patients taking the zinc supplement and those who are not. The CD4 lymphocytes value will be taken as an independent variable.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Adults suffering from HIV/AIDS, over 18 years of age with first- and second-line antiretroviral therapy.
• Patients with two viral loads less than 40 copies/ml (viral supression) and a stable or inferior CD4 lymphocyte count.
• Patients with body mass index over 18.5 kg/m2.
• Patients without opportunistic diseases.

Exclusion criteria

• Pregnant women.
• Hospitalized patients with cognitive disability evaluated by a doctor.
• Patients who are unwilling to participate.
• Patients taking zinc supplements.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

Placebo supplementation

Experimental group

Description:

Intervention Group B: Patients who will orally receive a placebo for 3 months.

Treatment:

Dietary Supplement: Placebo supplementation

zinc supplementation

Experimental group

Description:

Intervention group A. Patients who will orally receive zinc for 3 months.

Treatment:

Dietary Supplement: Zinc supplementation