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| Name | Class |
|---|---|
| University of Sao Paulo | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| zinc and selenium supplementation | Dietary Supplement | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Cardiac complications or other serious diseases such as:
autoimmune liver disease,
kidney failure,
cancer,
associated infections,
osteoporosis,
post-operative,
use of:
alcohol and
current smoking.
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| Name | Affiliation | Role |
|---|---|---|
| Dulcineia SP Abdalla, PhD | University of Sao Paulo | Study Director |
| Lucia FC Pedrosa, PhD | University of Rio Grande do Norte | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Onofre Lopes University Hospital | Natal | Rio Grande do Norte | 59.012.300 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25785441 | Derived | Sena-Evangelista KC, Pedrosa LF, Paiva MS, Dias PC, Ferreira DQ, Cozzolino SM, Faulin TE, Abdalla DS. The hypolipidemic and pleiotropic effects of rosuvastatin are not enhanced by its association with zinc and selenium supplementation in coronary artery disease patients: a double blind randomized controlled study. PLoS One. 2015 Mar 18;10(3):e0119830. doi: 10.1371/journal.pone.0119830. eCollection 2015. |
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| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| ID | Term |
|---|---|
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D015032 | Zinc |
| D000068718 | Rosuvastatin Calcium |
| ID | Term |
|---|---|
| D019216 | Metals, Heavy |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D028561 | Transition Elements |
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|
|
| rosuvastatin + placebo | Other | 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 |
|
|
| 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 |
| 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 |
| D008670 |
| Metals |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |