Zinc Supplementation Effect on Immune Recovery in HIV Patients

June 12, 2014 updated by: Heidy Contreras, CES University

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Colombia
    • Antioquia
      • Medellín, Antioquia, Colombia
        • Recruiting
        • Fundación SIAM

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Placebo supplementation
Intervention Group B: Patients who will orally receive a placebo for 3 months.
Dietary supplement: Placebo supplementation
Intervention Group B: Patients who will orally receive a placebo for 3 months.
Experimental: zinc supplementation
Intervention group A. Patients who will orally receive zinc for 3 months.
Dietary supplement: Zinc supplementation
Intervention group A: Patients who will orally receive zinc for 3 months.
Other Names:
  • Zinc Supplementation in Patients With HIV

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CES University

Collaborators

IPS Fundación SIAM

Investigators

  • Principal Investigator: Heidy Contreras, PhC., Researcher
  • Principal Investigator: Marcela Duque, MD., Researcher
  • Principal Investigator: Elsa Vásquez, Biologist, Researcher

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Anticipated)

June 1, 2014

Study Completion (Anticipated)

June 1, 2014

Study Registration Dates

First Submitted

May 29, 2014

First Submitted That Met QC Criteria

June 12, 2014

First Posted (Estimate)

June 13, 2014

Study Record Updates

Last Update Posted (Estimate)

June 13, 2014

Last Update Submitted That Met QC Criteria

June 12, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SUPL002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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