Kisel-10- a Prospective Randomized Double-blind Placebo Controlled Study of the Results of Intervention With Selenium and Coenzyme Q10 Combined, Regarding Effect With Emphasis on Cardiovascular Mortality and Morbidity.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 443
- 试验地点
- 2
- 主要终点
- Change in cardiovascular and all-cause mortality as effect of intervention
研究概览
简要总结
The dietary supplements selenium and Q10 has been evaluated in a double blind placebo-controlled study in an elderly Swedish population. The hypothesis is that as a majority of Northern Europeans suffers insufficient levels of selenium that is used by the cell in the building of at least 25 different enzyme systems in the body, and that the cell need presence of Q10 in order to produce the selenium containing enzymes, we wanted to evaluate the effect of a combined intervention of the two supplements in an elderly population in Sweden. All participants were controlled every 6 months, and the intervention was 48 months in each participant. Besides blood samples, echocardiography and cardiac natriuretic peptides were analyzed at start, every 6 months and at end of the study.
详细描述
The amount of patients suffering from heart failure is increasing throughout the Western hemisphere. The prognosis of heart failure is poor, in many cases worse than malignant diseases.
Several studies have demonstrated that by evaluating the plasma concentration of the natriuretic peptides that are stimulated by increased wall tension of the myocardium, it is possible to estimate the risk of cardiovascular mortality.
Scientific reports have demonstrated decreased symptoms of heart failure after selenium supplementation. Selenium, which is acquired by the body through food, often exists in low levels in the body in the northern parts of Europe due to poor levels of selenium in the soil. Animal studies have shown that selenium has a positive effect on the myocardium.
Ubiquinon, commonly called Q10, has a central position in many of the enzyme systems of the body. It has recently been shown that the body requires the presence of Q10 to produce selenium containing enzymes which are central in the energy handling processes of cells.
The aim of the present study is to evaluate whether the supplementation of selenium combined with Q10 can influence heart failure and cardiovascular mortality in an elderly population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 70 Years 至 87 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All elderly persons living in Kinda Municipality,
- •Sweden aged 70-87, who have accepted participation in the study, and who are expected to fulfill a study period of 4 years.
排除标准
- •Recent myocardial infarction (within 4 weeks).
- •Planned cardio-vascular operative procedure within 4 weeks.
- •Hesitation concerning if the candidate can decide for him/herself whether to participate in the study or not, or if he/she understands the consequences of participation.
- •Serious disease that substantially reduces survival or where it is not expected that the participant can cooperate for the full 4 year period.
- •Other factors making participation unreasonable, such as long/complicated transport to the Primary Health Center where the project is managed, or drug/alcohol abuse.
结局指标
主要结局
Change in cardiovascular and all-cause mortality as effect of intervention
时间窗: From start until 48 months of intervention
The cardiovascular and all-cause mortality is registered in the study population and an evaluation effect of intervention in terms of change in mortality will be analyzed
次要结局
- Change in cardiac function as measured by echocardiography and cardiac natriuretic peptides as effect of the intervention(From start until 48 months of intervention)
研究者
Urban Alehagen
Principal investigator
University Hospital, Linkoeping