Intervention With Selenium and Q10 on Cardiovascular Mortality and Cardiac Function in the Elderly Population in Sweden (KiSel-10)
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ClinicalTrials.gov Identifier: NCT01443780 |
Recruitment Status :
Completed
First Posted : September 30, 2011
Last Update Posted : October 3, 2011
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Condition or disease | Intervention/treatment | Phase |
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Cardiovascular Mortality Cardiac Function | Dietary Supplement: Selenium and ubiquinon (Q10) combined | Not Applicable |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 443 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Prevention |
Official 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. |
Study Start Date : | January 2003 |
Actual Primary Completion Date : | February 2010 |
Actual Study Completion Date : | February 2010 |

Arm | Intervention/treatment |
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Experimental: sellenium + Q10
Active dietary supplement that is compared against a placebo arm
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Dietary Supplement: Selenium and ubiquinon (Q10) combined
A combination of 200 mg/day of coenzyme Q10 (Bio-Quinon 100 mg B.I.D, Pharma Nord, Vejle, Denmark) and 200 µg/day of organic selenium (SelenoPrecise 200 µg, Pharma Nord), or placebo
Other Names:
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Placebo Comparator: Sugar pills
Placebo arm that is compared against active intervention with a dietary supplement with selenium + Q10
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Dietary Supplement: Selenium and ubiquinon (Q10) combined
A combination of 200 mg/day of coenzyme Q10 (Bio-Quinon 100 mg B.I.D, Pharma Nord, Vejle, Denmark) and 200 µg/day of organic selenium (SelenoPrecise 200 µg, Pharma Nord), or placebo
Other Names:
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- Change in cardiovascular and all-cause mortality as effect of intervention [ Time Frame: 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
- Change in cardiac function as measured by echocardiography and cardiac natriuretic peptides as effect of the intervention [ Time Frame: From start until 48 months of 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)

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Ages Eligible for Study: | 70 Years to 87 Years (Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01443780
Sweden | |
Dept of Cardiology, University Hospital of Linköping | |
Linköping, Sweden, Se-581 85 |
Principal Investigator: | Urban Alehagen, PhD, MD | Inst of Medicine and Health, University Hospital of Linköping, Sweden |
Responsible Party: | Urban Alehagen, Principal investigator, University Hospital, Linkoeping |
ClinicalTrials.gov Identifier: | NCT01443780 |
Other Study ID Numbers: |
KiSel-10 |
First Posted: | September 30, 2011 Key Record Dates |
Last Update Posted: | October 3, 2011 |
Last Verified: | September 2011 |
Selenium Q10 dietary supplement elderly population |
intervention All-cause mortality cardiac function |
Selenium Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents |
Physiological Effects of Drugs Trace Elements Micronutrients |