Zinc Supplementation Effect on Immune Recovery in HIV Patients
NCT ID: NCT02162797
Last Updated: 2014-06-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
40 participants
INTERVENTIONAL
2013-10-31
2014-06-30
Brief Summary
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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
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Placebo supplementation
Intervention Group B: Patients who will orally receive a placebo for 3 months.
Placebo supplementation
Intervention Group B: Patients who will orally receive a placebo for 3 months.
zinc supplementation
Intervention group A. Patients who will orally receive zinc for 3 months.
Zinc supplementation
Intervention group A: Patients who will orally receive zinc for 3 months.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Hospitalized patients with cognitive disability evaluated by a doctor.
* Patients who are unwilling to participate.
* Patients taking zinc supplements.
18 Years
ALL
Yes
Sponsors
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IPS Fundación SIAM
UNKNOWN
CES University
OTHER
Responsible Party
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Heidy Contreras
Researcher
Principal Investigators
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Heidy Contreras, PhC.
Role: PRINCIPAL_INVESTIGATOR
Researcher
Marcela Duque, MD.
Role: PRINCIPAL_INVESTIGATOR
Researcher
Elsa Vásquez, Biologist
Role: PRINCIPAL_INVESTIGATOR
Researcher
Locations
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Fundación SIAM
Medellín, Antioquia, Colombia
Countries
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Central Contacts
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Other Identifiers
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SUPL002
Identifier Type: -
Identifier Source: org_study_id
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