Zinc Supplementation Effect on Immune Recovery in HIV Patients

Not Applicable

• Conditions: HIV; AIDS; Immunological Deficiency; Inadequate Immune Recovery; Viral Replication
• Interventions: Dietary Supplement: Placebo supplementation; Dietary Supplement: Zinc supplementation

• Registration Number: NCT02162797
• Lead Sponsor: CES University

Brief Summary

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

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 Timeline

• Study Start: 2013-10
• Study First Submitted: 2014-05-29
• Status Verified: 2014-06
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Study First Submitted QC: 2014-06-12
• Last Update Submitted: 2014-06-12
• Study First Posted: 2014-06-13
• Last Update Posted: 2014-06-13

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo supplementation	Placebo supplementation	Intervention Group B: Patients who will orally receive a placebo for 3 months.
zinc supplementation	Zinc supplementation	Intervention group A. Patients who will orally receive zinc for 3 months.

Primary Outcome Measures

Name	Time	Method
Immunological Recovery	Three months	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).
EFFECT OF ZINC SUPPLEMENTATION ON IMMUNE RECOVERY PROGRAM HIV PATIENTS	THREE MONTHS	Compare the variation in levels of CD4 lymphocytes at baseline and three months after surgery (zinc or placebo) in each study patient.

Trial Locations

Locations (1)

Fundación SIAM; 🇨🇴 Medellín, Antioquia, Colombia