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Intervention With Selenium and Q10 on Cardiovascular Mortality and Cardiac Function in the Elderly Population in Sweden (KiSel-10)

This study has been completed.
Sponsor:
Collaborators:
Ostergotland County Council, Sweden
The Swedish Research Council
Pharma Nord
Information provided by (Responsible Party):
Urban Alehagen, University Hospital, Linkoeping
ClinicalTrials.gov Identifier:
NCT01443780
First received: September 28, 2011
Last updated: September 30, 2011
Last verified: September 2011
History of Changes
  Purpose

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.


Condition Intervention
Cardiovascular Mortality
Cardiac Function
 Dietary Supplement: Selenium and ubiquinon (Q10) combined

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Linkoeping:

Primary Outcome Measures:
  • Change in cardiovascular and all-cause mortality as effect of intervention [ Time Frame: From start until 48 months of intervention ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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)


Enrollment: 443
Study Start Date: January 2003
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: sellenium + Q10
Active dietary supplement that is compared against a placebo arm
 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:
  • Bio-Quinon 100mg
  • SelenoPrecise 200microgr
Placebo Comparator: Sugar pills
Placebo arm that is compared against active intervention with a dietary supplement with selenium + Q10
 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:
  • Bio-Quinon 100mg
  • SelenoPrecise 200microgr

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   70 Years to 87 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01443780

Locations
Sweden
Dept of Cardiology, University Hospital of Linköping
Linköping, Sweden, Se-581 85
Sponsors and Collaborators
University Hospital, Linkoeping
Ostergotland County Council, Sweden
The Swedish Research Council
Pharma Nord
Investigators
Principal Investigator: Urban Alehagen, PhD, MD Inst of Medicine and Health, University Hospital of Linköping, Sweden
  More Information

No publications provided

Responsible Party: Urban Alehagen, Principal investigator, University Hospital, Linkoeping
ClinicalTrials.gov Identifier: NCT01443780     History of Changes
Other Study ID Numbers: KiSel-10
Study First Received: September 28, 2011
Last Updated: September 30, 2011
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by University Hospital, Linkoeping:
Selenium
Q10
dietary supplement
elderly population
 intervention
All-cause mortality
cardiac function

Additional relevant MeSH terms:
Selenium
Coenzyme Q10
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
 Pharmacologic Actions
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Vitamins

ClinicalTrials.gov processed this record on May 16, 2013