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Zinc and Selenium Supplementation in Atherosclerosis

Primary Purpose

Dietary Selenium Deficiency, Dietary Zinc Deficiency

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
zinc and selenium supplementation
rosuvastatin + placebo
Sponsored by
Universidade Federal do Rio Grande do Norte
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dietary Selenium Deficiency focused on measuring atherosclerosis, zinc and selenium status, rosuvastatin, oxidative stress biomarkers, inflammation biomarkers

Eligibility Criteria

41 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • The study included adult and elderly patients, with coronary atherosclerosis and stable angina diagnosed by angiography showing ≥ 70% stenosis of the vessel lumen in at least one segment of a major epicardial artery or ≥ 50% stenosis of the diameter of the left main coronary artery, stable angina

Exclusion Criteria:

  • Cardiac complications or other serious diseases such as:

    • thyroid,
    • hematologic,
    • congenital,
  • autoimmune liver disease,
  • kidney failure,
  • cancer,
  • associated infections,
  • osteoporosis,
  • post-operative,

  • use of:

    • antacids,
    • antibiotics and
    • vitamin-mineral supplements,
  • alcohol and
  • current smoking.

Sites / Locations

  • Onofre Lopes University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

zinc and selenium supplementation

rosuvastatin + placebo

Arm Description

Patients received 10 mg rosuvastatin, concomitantly with zinc (30mg/d) and selenium (150μg/d) supplementation during 4 months

Patients received 10 mg rosuvastatin concomitantly placebo pills similar zinc and selenium supplementation

Outcomes

Primary Outcome Measures

Change from baseline in zinc and selenium status at 4 months
We evaluated the effects of 10mg rosuvastatin treatment as well as the effect of treatment with 10 mg rosuvastatin, concomitantly with zinc (30mg/d) and selenium (150μg/d) supplementation on plasma zinc and selenium and on erythrocyte zinc and selenium.

Secondary Outcome Measures

Change from baseline in lipid profile at 4 months
We evaluated the effects of 10mg rosuvastatin treatment as well as the effect of treatment with 10 mg rosuvastatin, concomitantly with zinc (30mg/d) and selenium (150μg/d) supplementation on total cholesterol, LDL, non-HDL cholesterol and, triglycerides.
Change from baseline in zinc and selenium status at 4 months
We evaluated the effects of 10mg rosuvastatin treatment as well as the effect of treatment with 10 mg rosuvastatin, concomitantly with zinc (30mg/d) and selenium (150μg/d) supplementation on LDL (-), anti-LDL (-), immune complexes concentrations, SOD and GPx activities.
Change from baseline in inflammation biomarkers status at 4 months
We evaluated the effect of oral zinc and selenium supplementation, concomitant with rosuvastatin treatment, on hs-CRP and IL-6 levels.

Full Information

First Posted
February 22, 2012
Last Updated
March 2, 2012
Sponsor
Universidade Federal do Rio Grande do Norte
Collaborators
University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT01547377
Brief Title
Zinc and Selenium Supplementation in Atherosclerosis
Official Title
Effect of Zinc and Selenium Supplementation in Patients With Atherosclerosis Treated With Statins
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
November 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal do Rio Grande do Norte
Collaborators
University of Sao Paulo

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of this randomized double-blind study was to evaluate the effect of oral zinc and selenium supplementation on oxidative stress and inflammation biomarkers as well as the status of zinc and selenium in patients with atherosclerosis and angina stable treated with rosuvastatin. The hypotheses tested in this study were: Treatment with rosuvastatin impairs zinc and selenium status in patients with atherosclerosis and stable angina? Zinc and selenium supplementation, concomitantly with rosuvastatin, influences the antioxidant and anti-inflammatory as well as the status of minerals?
Detailed Description
The study included 47 men and 29 women, average age around 60 years, with coronary atherosclerosis diagnosed by angiography. Data from patients were obtained at beginning and after four months of treatment with 10 mg rosuvastatin, concomitantly with zinc (30mg/d) and selenium (150μg/d) supplementation or placebo. The anthropometric and dietary data, zinc and selenium concentrations in plasma and erythrocyte, lipid profile, electronegative LDL (LDL(-)), anti- electronegative LDL, Ac-LDL(-) immune complexes, GPx and SOD activities, IL-6 and hs-CRP were evaluated in all patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dietary Selenium Deficiency, Dietary Zinc Deficiency
Keywords
atherosclerosis, zinc and selenium status, rosuvastatin, oxidative stress biomarkers, inflammation biomarkers

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
76 (Actual)

8. Arms, Groups, and Interventions

Arm Title
zinc and selenium supplementation
Arm Type
Experimental
Arm Description
Patients received 10 mg rosuvastatin, concomitantly with zinc (30mg/d) and selenium (150μg/d) supplementation during 4 months
Arm Title
rosuvastatin + placebo
Arm Type
Placebo Comparator
Arm Description
Patients received 10 mg rosuvastatin concomitantly placebo pills similar zinc and selenium supplementation
Intervention Type
Dietary Supplement
Intervention Name(s)
zinc and selenium supplementation
Other Intervention Name(s)
Zinc and selenium supplementation + rosuvastatin
Intervention Description
Data from patients were obtained at beginning and after four months of treatment with 10 mg rosuvastatin, concomitantly with zinc (30mg/d) and selenium (150μg/d) supplementation or placebo. The anthropometric and dietary data, zinc and selenium concentrations in plasma and erythrocyte, lipid profile, electronegative LDL (LDL(-)), anti- electronegative LDL, Ac-LDL(-) immune complexes, GPx and SOD activities, IL-6 and hs-CRP were evaluated in all patients
Intervention Type
Other
Intervention Name(s)
rosuvastatin + placebo
Other Intervention Name(s)
placebo group
Intervention Description
Data from patients were obtained at beginning and after four months of treatment with 10 mg rosuvastatin, concomitantly with zinc (30mg/d) and selenium (150μg/d) supplementation or placebo. The anthropometric and dietary data, zinc and selenium concentrations in plasma and erythrocyte, lipid profile, electronegative LDL (LDL(-)), anti- electronegative LDL, Ac-LDL(-) immune complexes, GPx and SOD activities, IL-6 and hs-CRP were evaluated in all patients
Primary Outcome Measure Information:
Title
Change from baseline in zinc and selenium status at 4 months
Description
We evaluated the effects of 10mg rosuvastatin treatment as well as the effect of treatment with 10 mg rosuvastatin, concomitantly with zinc (30mg/d) and selenium (150μg/d) supplementation on plasma zinc and selenium and on erythrocyte zinc and selenium.
Time Frame
Baseline and 4 months
Secondary Outcome Measure Information:
Title
Change from baseline in lipid profile at 4 months
Description
We evaluated the effects of 10mg rosuvastatin treatment as well as the effect of treatment with 10 mg rosuvastatin, concomitantly with zinc (30mg/d) and selenium (150μg/d) supplementation on total cholesterol, LDL, non-HDL cholesterol and, triglycerides.
Time Frame
Baseline and 4 months
Title
Change from baseline in zinc and selenium status at 4 months
Description
We evaluated the effects of 10mg rosuvastatin treatment as well as the effect of treatment with 10 mg rosuvastatin, concomitantly with zinc (30mg/d) and selenium (150μg/d) supplementation on LDL (-), anti-LDL (-), immune complexes concentrations, SOD and GPx activities.
Time Frame
Baseline and 4 months
Title
Change from baseline in inflammation biomarkers status at 4 months
Description
We evaluated the effect of oral zinc and selenium supplementation, concomitant with rosuvastatin treatment, on hs-CRP and IL-6 levels.
Time Frame
Baseline and 4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
41 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The study included adult and elderly patients, with coronary atherosclerosis and stable angina diagnosed by angiography showing ≥ 70% stenosis of the vessel lumen in at least one segment of a major epicardial artery or ≥ 50% stenosis of the diameter of the left main coronary artery, stable angina Exclusion Criteria: Cardiac complications or other serious diseases such as: thyroid, hematologic, congenital, autoimmune liver disease, kidney failure, cancer, associated infections, osteoporosis, post-operative, use of: antacids, antibiotics and vitamin-mineral supplements, alcohol and current smoking.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dulcineia SP Abdalla, PhD
Organizational Affiliation
University of São Paulo
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Lucia FC Pedrosa, PhD
Organizational Affiliation
University of Rio Grande do Norte
Official's Role
Study Director
Facility Information:
Facility Name
Onofre Lopes University Hospital
City
Natal
State/Province
Rio Grande do Norte
ZIP/Postal Code
59.012.300
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
25785441
Citation
Sena-Evangelista KC, Pedrosa LF, Paiva MS, Dias PC, Ferreira DQ, Cozzolino SM, Faulin TE, Abdalla DS. The hypolipidemic and pleiotropic effects of rosuvastatin are not enhanced by its association with zinc and selenium supplementation in coronary artery disease patients: a double blind randomized controlled study. PLoS One. 2015 Mar 18;10(3):e0119830. doi: 10.1371/journal.pone.0119830. eCollection 2015.
Results Reference
derived

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Zinc and Selenium Supplementation in Atherosclerosis

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