Zinc Supplementation Effect on Immune Recovery in HIV Patients

CES University40 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

HIV

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Immunological Recovery

Zinc supplementation is expected to enhance the immunological response of HIV+ patients. This can be demonstrated comparing the initial analysis with the final report (3 months later).

Time frame: Three months

EFFECT OF ZINC SUPPLEMENTATION ON IMMUNE RECOVERY PROGRAM HIV PATIENTS

Compare the variation in levels of CD4 lymphocytes at baseline and three months after surgery (zinc or placebo) in each study patient.

Time frame: THREE MONTHS

Zinc Supplementation Effect on Immune Recovery in HIV Patients

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Central Contacts