Cardiac Function Clinical Trial
— KiSel-10Official title:
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.
Verified date | September 2011 |
Source | University Hospital, Linkoeping |
Contact | n/a |
Is FDA regulated | No |
Health authority | Sweden: Regional Ethical Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 443 |
Est. completion date | February 2010 |
Est. primary completion date | February 2010 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 70 Years to 87 Years |
Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - 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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Sweden | Dept of Cardiology, University Hospital of Linköping | Linköping |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Linkoeping | Ostergotland County Council, Sweden, Pharma Nord, The Swedish Research Council |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in cardiovascular and all-cause mortality as effect 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 | From start until 48 months of intervention | No |
Secondary | Change in cardiac function as measured by echocardiography and cardiac natriuretic peptides as effect of the intervention | In every participant the cardiac function will be evaluated through echocardiography and cardiac natriuretic peptides. The evaluation through echocardiography will be performed at start and at end of the study, while the cardiac natriuretic peptides will be analyzed every 6 months during the study period. Evaluation of cardiac function will be compared between the two intervention groups (active vs placebo) | From start until 48 months of intervention | No |
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