Zinc and Selenium Supplementation in Atherosclerosis

Dietary Zinc Deficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01547377
• Other study ID #: PROJ-981-199697778
• Status: Completed
• Phase: N/A
• First received: February 22, 2012
• Last updated: March 2, 2012
• Start date: January 2008
• Est. completion date: November 2009

Study information

• Verified date: March 2012
• Source: Universidade Federal do Rio Grande do Norte
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: November 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 41 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atherosclerosis
• Dietary Selenium Deficiency
• Dietary Zinc Deficiency

Intervention

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:
• 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

Locations

Country	Name	City	State
Brazil	Onofre Lopes University Hospital	Natal	Rio Grande do Norte

Sponsors (2)

Lead Sponsor	Collaborator
Universidade Federal do Rio Grande do Norte	University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline and 4 months	Yes
Secondary	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.	Baseline and 4 months	Yes
Secondary	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.	Baseline and 4 months	Yes
Secondary	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.	Baseline and 4 months	Yes