Trials / Completed
CompletedNCT01547377
Zinc and Selenium Supplementation in Atherosclerosis
Effect of Zinc and Selenium Supplementation in Patients With Atherosclerosis Treated With Statins
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 76 (actual)
- Sponsor
- Universidade Federal do Rio Grande do Norte · Academic / Other
- Sex
- All
- Age
- 41 Years – 80 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2008-01-01
- Primary completion
- 2009-04-01
- Completion
- 2009-11-01
- First posted
- 2012-03-07
- Last updated
- 2012-03-07
Locations
1 site across 1 country: Brazil
Source: ClinicalTrials.gov record NCT01547377. Inclusion in this directory is not an endorsement.