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Zinc Supplementation Effect on Immune Recovery in HIV Patients

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ClinicalTrials.gov Identifier: NCT02162797
Recruitment Status : Unknown
Verified June 2014 by Heidy Contreras, CES University.
Recruitment status was:  Recruiting
First Posted : June 13, 2014
Last Update Posted : June 13, 2014
Sponsor:
Collaborator:
IPS Fundación SIAM
Information provided by (Responsible Party):
Heidy Contreras, CES University

Study Description
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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


Condition or disease Intervention/treatment Phase
HIV AIDS Immunological Deficiency Inadequate Immune Recovery Viral Replication Dietary Supplement: Zinc supplementation Dietary Supplement: Placebo supplementation Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: EFFECT OF ZINC SUPPLEMENTATION ON IMMUNE RECOVERY PROGRAM HIV PATIENTS WITH AN IPS MEDELLIN
Study Start Date : October 2013
Estimated Primary Completion Date : June 2014
Estimated Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arms and Interventions
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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 Name: Zinc Supplementation in Patients With HIV


Outcome Measures
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Primary Outcome Measures :
  1. 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).

  2. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02162797


Contacts
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Contact: MARCELA DUQUE 3136461538 marduque@gmail.com
Contact: HEIDY CONTRERAS 3113710971 heidycm@gmail.com

Locations
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Colombia
Fundación SIAM Recruiting
Medellín, Antioquia, Colombia
Sponsors and Collaborators
CES University
IPS Fundación SIAM
Investigators
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Principal Investigator: Heidy Contreras, PhC. Researcher
Principal Investigator: Marcela Duque, MD. Researcher
Principal Investigator: Elsa Vásquez, Biologist Researcher
More Information
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Responsible Party: Heidy Contreras, Researcher, CES University
ClinicalTrials.gov Identifier: NCT02162797    
Other Study ID Numbers: SUPL002
First Posted: June 13, 2014    Key Record Dates
Last Update Posted: June 13, 2014
Last Verified: June 2014
Keywords provided by Heidy Contreras, CES University:
HIV
AIDS
zinc
zinc supplement
immunological deficiency
Additional relevant MeSH terms:
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Zinc
Trace Elements
Micronutrients
Physiological Effects of Drugs