Dietary Selenium Deficiency, Dietary Zinc Deficiency
Conditions
Keywords
atherosclerosis, zinc and selenium status, rosuvastatin, oxidative stress biomarkers, inflammation biomarkers
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.
Interventions
DIETARY_SUPPLEMENTzinc 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
OTHERrosuvastatin + 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
Sponsors
University of Sao Paulo
Universidade Federal do Rio Grande do Norte
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
41 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Brazil
Outcome results
None listed