Zinc Supplementation Effect on Immune Recovery in HIV Patients

HIV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02162797
• Other study ID #: SUPL002
• Status: Recruiting
• Phase: N/A
• First received: May 29, 2014
• Last updated: June 12, 2014
• Start date: October 2013
• Est. completion date: June 2014

Study information

• Verified date: June 2014
• Source: CES University
• Contact: MARCELA DUQUE
• Phone: 3136461538
• Email: marduque[@]gmail.com
• Is FDA regulated: No
• Health authority: Colombia: INVIMA
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• AIDS
• HIV
• Immunological Deficiency
• Inadequate Immune Recovery
• Viral Replication

Intervention

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

Locations

Country	Name	City	State
Colombia	Fundación SIAM	Medellín	Antioquia

Sponsors (2)

Lead Sponsor	Collaborator
CES University	IPS Fundación SIAM

Country where clinical trial is conducted

Colombia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	No