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Completed

NCT Number: NCT01547377

Zinc and Selenium Supplementation in Atherosclerosis

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?

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Key information

Conditions

Dietary Selenium Deficiency Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Dietary Zinc Deficiency Vascular Diseases

Age range

41 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Onofre Lopes University Hospital

Natal, Rio Grande do Norte, 59.012.300, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

zinc and selenium supplementation

Dietary Supplement

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 names: Zinc and selenium supplementation + rosuvastatin

rosuvastatin + placebo

Other

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 names: placebo group

Primary outcomes

  1. Change from baseline in zinc and selenium status at 4 months

    Time frame: Baseline and 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 outcomes

  1. Change from baseline in lipid profile at 4 months

    Time frame: Baseline and 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.

  2. Change from baseline in zinc and selenium status at 4 months

    Time frame: Baseline and 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.

  3. Change from baseline in inflammation biomarkers status at 4 months

    Time frame: Baseline and 4 months

    We evaluated the effect of oral zinc and selenium supplementation, concomitant with rosuvastatin treatment, on hs-CRP and IL-6 levels.

Sponsors and collaborators

Lead sponsor

Universidade Federal do Rio Grande do Norte

Other

Collaborators

  • University of Sao Paulo

Registry information

Official study title

Effect of Zinc and Selenium Supplementation in Patients With Atherosclerosis Treated With Statins

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Mar 7, 2012
Registry last updated
Mar 7, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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