Zinc and Selenium Supplementation in Atherosclerosis

Not Applicable

Completed

• Conditions: Dietary Selenium Deficiency; Dietary Zinc Deficiency
• Interventions: Dietary Supplement: zinc and selenium supplementation; Other: rosuvastatin + placebo

• Registration Number: NCT01547377
• Lead Sponsor: Universidade Federal do Rio Grande do Norte

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.

Study Timeline

• Study Start: 2008-01
• Primary Completion: 2009-04
• Study Completion: 2009-11
• Study First Submitted: 2012-02-22
• Status Verified: 2012-03
• Study First Submitted QC: 2012-03-02
• Last Update Submitted: 2012-03-02
• Study First Posted: 2012-03-07
• Last Update Posted: 2012-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
zinc and selenium supplementation	zinc and selenium supplementation	Patients received 10 mg rosuvastatin, concomitantly with zinc (30mg/d) and selenium (150μg/d) supplementation during 4 months
rosuvastatin + placebo	rosuvastatin + placebo	Patients received 10 mg rosuvastatin concomitantly placebo pills similar zinc and selenium supplementation

Primary Outcome Measures

Name	Time	Method
Change from baseline in zinc and selenium status at 4 months	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 Outcome Measures

Name	Time	Method
Change from baseline in lipid profile at 4 months	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.
Change from baseline in zinc and selenium status at 4 months	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.
Change from baseline in inflammation biomarkers status at 4 months	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.

Trial Locations

Locations (1)

Onofre Lopes University Hospital; 🇧🇷 Natal, Rio Grande do Norte, Brazil