Zinc Supplementation Effect on Immune Recovery in HIV Patients

Sponsor

CES University (Other)

Overall Status

Unknown status

CT.gov ID

NCT02162797

Collaborator

IPS Fundación SIAM (Other)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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

Study Type:

Interventional

Anticipated 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 :

Oct 1, 2013

Anticipated Primary Completion Date :

Jun 1, 2014

Anticipated Study Completion Date :

Jun 1, 2014

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.