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Zinc and Selenium Supplementation in Atherosclerosis

This study has been completed.
Sponsor:
Collaborator:
University of Sao Paulo
Information provided by (Responsible Party):
Karine C M Sena-Evangelista, Universidade Federal do Rio Grande do Norte
ClinicalTrials.gov Identifier:
NCT01547377
First received: February 22, 2012
Last updated: March 2, 2012
Last verified: March 2012
History of Changes
  Purpose

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?


Condition Intervention
Dietary Selenium Deficiency
Dietary Zinc Deficiency
 Dietary Supplement: zinc and selenium supplementation
Other: rosuvastatin + placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Zinc and Selenium Supplementation in Patients With Atherosclerosis Treated With Statins

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Universidade Federal do Rio Grande do Norte:

Primary Outcome Measures:
  • Change from baseline in zinc and selenium status at 4 months [ Time Frame: Baseline and 4 months ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Baseline and 4 months ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Baseline and 4 months ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Baseline and 4 months ] [ Designated as safety issue: Yes ]
    We evaluated the effect of oral zinc and selenium supplementation, concomitant with rosuvastatin treatment, on hs-CRP and IL-6 levels.


Enrollment: 76
Study Start Date: January 2008
Study Completion Date: November 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: zinc and selenium supplementation
Patients received 10 mg rosuvastatin, concomitantly with zinc (30mg/d) and selenium (150μg/d) supplementation during 4 months
 Dietary Supplement: zinc and selenium supplementation
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
Other Name: Zinc and selenium supplementation + rosuvastatin
Placebo Comparator: rosuvastatin + placebo
Patients received 10 mg rosuvastatin concomitantly placebo pills similar zinc and selenium supplementation
 Other: rosuvastatin + placebo
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
Other Name: placebo group

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.

  Eligibility

Ages Eligible for Study:   41 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01547377

Locations
Brazil
Onofre Lopes University Hospital
Natal, Rio Grande do Norte, Brazil, 59.012.300
Sponsors and Collaborators
Universidade Federal do Rio Grande do Norte
University of Sao Paulo
Investigators
Study Director: Dulcineia SP Abdalla, PhD University of São Paulo
Study Director: Lucia FC Pedrosa, PhD University of Rio Grande do Norte
  More Information

No publications provided

Responsible Party: Karine C M Sena-Evangelista, Principal Investigator, Universidade Federal do Rio Grande do Norte
ClinicalTrials.gov Identifier: NCT01547377     History of Changes
Other Study ID Numbers: PROJ-981-199697778
Study First Received: February 22, 2012
Last Updated: March 2, 2012
Health Authority: Brazil: Ethics Committee

Keywords provided by Universidade Federal do Rio Grande do Norte:
atherosclerosis
zinc and selenium status
rosuvastatin
oxidative stress biomarkers
inflammation biomarkers

Additional relevant MeSH terms:
Selenium
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Zinc
Rosuvastatin
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
 Pharmacologic Actions
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013