Clinical trial NCT02162797: Zinc Supplementation Effect on Immune Recovery in HIV Patients
Official title: EFFECT OF ZINC SUPPLEMENTATION ON IMMUNE RECOVERY PROGRAM HIV PATIENTS WITH AN IPS MEDELLIN
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: HIV
AIDS
Immunological Deficiency
Inadequate Immune Recovery
Viral Replication
Keywords: HIV
AIDS
zinc
zinc supplement
immunological deficiency
Lead sponsor: CES University
Sponsor class: OTHER
Collaborators: name: IPS Fundación SIAM
First posted: 2014-06-13
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Immunological Recovery
timeFrame: Three months
measure: EFFECT OF ZINC SUPPLEMENTATION ON IMMUNE RECOVERY PROGRAM HIV PATIENTS
timeFrame: THREE MONTHS
Secondary outcomes:
Other outcomes:
Locations:
city: Medellín
country: Colombia
facility: Fundación SIAM
state: Antioquia
Study officials:
affiliation: Researcher
name: Heidy Contreras, PhC.
role: PRINCIPAL_INVESTIGATOR
affiliation: Researcher
name: Marcela Duque, MD.
role: PRINCIPAL_INVESTIGATOR
affiliation: Researcher
name: Elsa Vásquez, Biologist
role: PRINCIPAL_INVESTIGATOR
References: