Trial | NCT01547377  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    76
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?
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 Started
Jan 31
2008
Primary Completion
Apr 30
2009
Study Completion
Nov 30
2009
Last Update
Mar 07
2012
Estimate

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 names: Zinc and selenium supplementation + rosuvastatin

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 names: placebo group

zinc and selenium supplementation Experimental

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

rosuvastatin + placebo Placebo Comparator

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

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.
No Results Posted