Effect of Zinc and Selenium Supplementation in Patients With Atherosclerosis Treated With Statins
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Change from baseline in zinc and selenium status at 4 months
研究概览
简要总结
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?
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 41 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Cardiac complications or other serious diseases such as:
- •hematologic,
- •congenital,
- •autoimmune liver disease,
- •kidney failure,
- •associated infections,
- •osteoporosis,
- •post-operative,
- •antacids,
- •antibiotics and
- •vitamin-mineral supplements,
- •alcohol and
- •current smoking.
研究组 & 干预措施
zinc and selenium supplementation
Patients received 10 mg rosuvastatin, concomitantly with zinc (30mg/d) and selenium (150μg/d) supplementation during 4 months
干预措施: zinc and selenium supplementation (Dietary Supplement)
rosuvastatin + placebo
Patients received 10 mg rosuvastatin concomitantly placebo pills similar zinc and selenium supplementation
干预措施: rosuvastatin + placebo (Other)
结局指标
主要结局
Change from baseline in zinc and selenium status at 4 months
时间窗: 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.
次要结局
- Change from baseline in lipid profile at 4 months(Baseline and 4 months)
- Change from baseline in zinc and selenium status at 4 months(Baseline and 4 months)
- Change from baseline in inflammation biomarkers status at 4 months(Baseline and 4 months)
研究者
Karine C M Sena-Evangelista
Principal Investigator
Universidade Federal do Rio Grande do Norte