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Effect of Zinc and Selenium Supplementation on HIV+ Individuals on Antiretroviral Treatment.

Primary Purpose

HIV, ART, Zinc Deficiency

Status
Unknown status
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Zinc gluconate and/or Selenium yeast
Sponsored by
Instituto Nacional de Enfermedades Respiratorias
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for HIV

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • HIV infected
  • >200 CD4+ cells/mL
  • >2 years under antiretroviral treatment
  • >2 years under virology control (HIV RNA <40 copies/mL)

Exclusion Criteria:

  • Patients with opportunistic infection
  • Patients taking vitamin-mineral supplements
  • Patients with moderate or high cardiovascular risk (Framingham score higher than 10%) and cholesterol LDL >190 mg/dL or triglycerides >500 mg/dL.
  • Patients with diabetes or hypertension diagnosis.
  • Patients taking drugs for diabetes, hypertension, dyslipidemia or low bone mass density.
  • Low adherence to supplementation.

Sites / Locations

  • Centro de Investigaciones en Enfermedades InfecciosasRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

No Intervention

Arm Label

Zinc

Selenium

Zinc + Selenium

Control

Arm Description

Participants in this arm will take a daily 30 mg dose of zinc gluconate during 6 months

Participants in this arm will take a daily 200 mcg of selenium yeast during 6 months

Participants in this arm will take a daily 30 mg dose of zinc gluconate + 200 mcg of selenium yeast during 6 months

Participants in this arm will not take supplementation as a control.

Outcomes

Primary Outcome Measures

Changes from baseline in zinc and selenium plasmatic levels
We evaluated the effects of zinc (30mg/d) and selenium (200μg/d) supplementation on plasma zinc and selenium levels.

Secondary Outcome Measures

Counts of CD4+ T cells
Changes in fasting serum glucose
Changes in blood pressure
Changes in lipid peroxidation
Measure by TBARS
Changes in proinflammatory cytokine profile
Measure by LUMINEX
Changes in bone metabolism biomarkers
Changes in osteoprotegerin and RANKL levels
Frequency of CD4+ T cells
Measure by flow cytometry
Changes in total cholesterol
in mg/dL
Changes in LDL cholesterol
in mg/dL
Changes in HDL cholesterol
in mg/dL
Changes in triglycerides
in mg/dL
Changes in body weight
in Kg
Changes in fat mass
in Kg
Changes in lean soft tissue
in Kg
Changes in and bone mineral density
g/cm3

Full Information

First Posted
January 10, 2018
Last Updated
January 29, 2019
Sponsor
Instituto Nacional de Enfermedades Respiratorias
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1. Study Identification

Unique Protocol Identification Number
NCT03421314
Brief Title
Effect of Zinc and Selenium Supplementation on HIV+ Individuals on Antiretroviral Treatment.
Official Title
Effect of Zinc and Selenium Supplementation on Clinical and Immunological Parameters on HIV+ Individuals on Antiretroviral Treatment.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2016 (Actual)
Primary Completion Date
December 31, 2019 (Anticipated)
Study Completion Date
January 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto Nacional de Enfermedades Respiratorias

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of this study is to evaluate the effect of zinc gluconate and/or selenium yeast supplementation during six months on clinical (glucose, cholesterol, triglycerides, bone mineral density and body composition) and immunological (oxidative stress, CD4+ count and pro-inflammatory cytokines) parameters in a population with HIV diagnosis on antiretroviral treatment.
Detailed Description
HIV-infected individuals on antiretroviral treatment have lowest risk of AIDS events and more life expectancy. However, antiretroviral treatment does not fully restore the immune system in all individuals due to persistent immune activation and inflammation, increasing the risk of non-AIDS complications, such as insulin resistance, diabetes, hypertension, dyslipidemia, obesity, low bone mass density, oxidative stress and micronutrient deficiencies. Several studies showed that HIV+ patients present zinc and selenium deficiency. Those micronutrients are involved in the pathogenesis of metabolic complications and have a major role in maintaining immune system function. It remains unknown the effect of zinc and selenium supplementation on metabolic and immunological parameters associated to non-AIDS complications.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV, ART, Zinc Deficiency, Selenium Deficiency, Metabolic Complication, Inflammation

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Masking Description
Triple
Allocation
Randomized
Enrollment
37 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Zinc
Arm Type
Experimental
Arm Description
Participants in this arm will take a daily 30 mg dose of zinc gluconate during 6 months
Arm Title
Selenium
Arm Type
Experimental
Arm Description
Participants in this arm will take a daily 200 mcg of selenium yeast during 6 months
Arm Title
Zinc + Selenium
Arm Type
Experimental
Arm Description
Participants in this arm will take a daily 30 mg dose of zinc gluconate + 200 mcg of selenium yeast during 6 months
Arm Title
Control
Arm Type
No Intervention
Arm Description
Participants in this arm will not take supplementation as a control.
Intervention Type
Dietary Supplement
Intervention Name(s)
Zinc gluconate and/or Selenium yeast
Intervention Description
30 mg dose of zinc gluconate and/or 200 mcg of selenium yeast
Primary Outcome Measure Information:
Title
Changes from baseline in zinc and selenium plasmatic levels
Description
We evaluated the effects of zinc (30mg/d) and selenium (200μg/d) supplementation on plasma zinc and selenium levels.
Time Frame
Baseline and 24 weeks
Secondary Outcome Measure Information:
Title
Counts of CD4+ T cells
Time Frame
Baseline,12 and 24 weeks
Title
Changes in fasting serum glucose
Time Frame
Baseline,12 and 24 weeks
Title
Changes in blood pressure
Time Frame
Baseline,12 and 24 weeks
Title
Changes in lipid peroxidation
Description
Measure by TBARS
Time Frame
Baseline and 24 weeks
Title
Changes in proinflammatory cytokine profile
Description
Measure by LUMINEX
Time Frame
Baseline and 24 weeks
Title
Changes in bone metabolism biomarkers
Description
Changes in osteoprotegerin and RANKL levels
Time Frame
Baseline and 24 weeks
Title
Frequency of CD4+ T cells
Description
Measure by flow cytometry
Time Frame
Baseline,12 and 24 weeks
Title
Changes in total cholesterol
Description
in mg/dL
Time Frame
Baseline,12 and 24 weeks
Title
Changes in LDL cholesterol
Description
in mg/dL
Time Frame
Baseline,12 and 24 weeks
Title
Changes in HDL cholesterol
Description
in mg/dL
Time Frame
Baseline,12 and 24 weeks
Title
Changes in triglycerides
Description
in mg/dL
Time Frame
Baseline,12 and 24 weeks
Title
Changes in body weight
Description
in Kg
Time Frame
Baseline,12 and 24 weeks
Title
Changes in fat mass
Description
in Kg
Time Frame
Baseline,12 and 24 weeks
Title
Changes in lean soft tissue
Description
in Kg
Time Frame
Baseline,12 and 24 weeks
Title
Changes in and bone mineral density
Description
g/cm3
Time Frame
Baseline,12 and 24 weeks

10. Eligibility

Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: HIV infected >200 CD4+ cells/mL >2 years under antiretroviral treatment >2 years under virology control (HIV RNA <40 copies/mL) Exclusion Criteria: Patients with opportunistic infection Patients taking vitamin-mineral supplements Patients with moderate or high cardiovascular risk (Framingham score higher than 10%) and cholesterol LDL >190 mg/dL or triglycerides >500 mg/dL. Patients with diabetes or hypertension diagnosis. Patients taking drugs for diabetes, hypertension, dyslipidemia or low bone mass density. Low adherence to supplementation.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ivan Osuna Padilla, MD
Phone
56667985
Ext
109
Email
ivan.osuna@cieni.org.mx
First Name & Middle Initial & Last Name or Official Title & Degree
Olivia Briceño Cárdenas, PhD
Phone
56667985
Ext
140
Email
olivia@cieni.org.mx
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gustavo Reyes Teran, MD
Organizational Affiliation
Principal investgator
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centro de Investigaciones en Enfermedades Infecciosas
City
Mexico city
State/Province
DF
ZIP/Postal Code
14080
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ivan Osuna Padilla, MD
Phone
56667085
Ext
109
Email
ivan.osuna@cieni.org.mx
First Name & Middle Initial & Last Name & Degree
Gustavo Reyes-Terán, MD
First Name & Middle Initial & Last Name & Degree
Ivan Osuna Padilla, MD
First Name & Middle Initial & Last Name & Degree
Olivia Briceño Cárdenas, PhD
First Name & Middle Initial & Last Name & Degree
Nadia Rodriguez Moguel, MD
First Name & Middle Initial & Last Name & Degree
Adriana Aguilar Vargas, MD

12. IPD Sharing Statement

Learn more about this trial

Effect of Zinc and Selenium Supplementation on HIV+ Individuals on Antiretroviral Treatment.

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