Zinc Supplementation Effect on Immune Recovery in HIV Patients

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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EFFECT OF ZINC SUPPLEMENTATION ON IMMUNE RECOVERY PROGRAM HIV PATIENTS WITH AN IPS MEDELLIN

Conditions
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HIV, AIDS, Immunological Deficiency, Inadequate Immune Recovery, Viral Replication

Intervention / Treatment
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* Dietary Supplement: Zinc supplementation
* Dietary Supplement: Placebo supplementation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Placebo supplementation<br>Intervention Group B: Patients who will orally receive a placebo for 3 months. | Dietary Supplement: Placebo supplementation<br>* Intervention Group B: Patients who will orally receive a placebo for 3 months.<br>|
| Experimental: zinc supplementation<br>Intervention group A. Patients who will orally receive zinc for 3 months. | Dietary Supplement: Zinc supplementation<br>* Intervention group A: Patients who will orally receive zinc for 3 months.<br>* Other names: Zinc Supplementation in Patients With HIV;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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. | THREE MONTHS | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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zinc, HIV, AIDS, zinc supplement, immunological deficiency