Intervention With Selenium and Q10 on Cardiovascular Mortality and Cardiac Function in the Elderly Population in Sweden

NCT01443780 | Completed

• 1 other identifier: KiSel-10
• Study Type: interventional
• Target: 443
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cardiovascular Mortality; Cardiac Function

Keywords

Selenium; Q10; dietary supplement; elderly population; intervention; All-cause mortality; cardiac function

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Change in cardiac function as measured by echocardiography and cardiac natriuretic peptides as effect of the intervention

  From start until 48 months of intervention

Study Arms (2)

sellenium + Q10

EXPERIMENTAL

Active dietary supplement that is compared against a placebo arm

Dietary Supplement: Selenium and ubiquinon (Q10) combined

Sugar pills

PLACEBO COMPARATOR

Placebo arm that is compared against active intervention with a dietary supplement with selenium + Q10

Dietary Supplement: Selenium and ubiquinon (Q10) combined

Interventions

Selenium and ubiquinon (Q10) combined DIETARY_SUPPLEMENT

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

Also known as: Bio-Quinon 100mg, SelenoPrecise 200microgr

Sugar pills; sellenium + Q10

Eligibility Criteria

• Age: 70 Years - 87 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Linkoeping: lead
• Ostergotland County Council, Sweden: collaborator
• The Swedish Research Council: collaborator
• Pharma Nord: collaborator

Study Sites (1)

Dept of Cardiology, University Hospital of Linköping

Linköping, Se-581 85, Sweden

Location

Related Publications (9)

• Alehagen U, Alexander J, Aaseth JO, Larsson A, Opstad TB. Supplementation with selenium and coenzyme Q10 in an elderly Swedish population low in selenium - positive effects on thyroid hormones, cardiovascular mortality, and quality of life. BMC Med. 2024 May 7;22(1):191. doi: 10.1186/s12916-024-03411-1.

  PMID: 38714999 DERIVED

• Alehagen U, Johansson P, Svensson E, Aaseth J, Alexander J. Improved cardiovascular health by supplementation with selenium and coenzyme Q10: applying structural equation modelling (SEM) to clinical outcomes and biomarkers to explore underlying mechanisms in a prospective randomized double-blind placebo-controlled intervention project in Sweden. Eur J Nutr. 2022 Sep;61(6):3135-3148. doi: 10.1007/s00394-022-02876-1. Epub 2022 Apr 6.

  PMID: 35381849 DERIVED

• Alehagen U, Aaseth J, Larsson A, Alexander J. Decreased Concentration of Fibroblast Growth Factor 23 (FGF-23) as a Result of Supplementation with Selenium and Coenzyme Q10 in an Elderly Swedish Population: A Sub-Analysis. Cells. 2022 Feb 1;11(3):509. doi: 10.3390/cells11030509.

  PMID: 35159318 DERIVED

• Alehagen U, Aaseth J, Alexander J, Johansson P, Larsson A. Supplemental selenium and coenzyme Q10 reduce glycation along with cardiovascular mortality in an elderly population with low selenium status - A four-year, prospective, randomised, double-blind placebo-controlled trial. J Trace Elem Med Biol. 2020 Sep;61:126541. doi: 10.1016/j.jtemb.2020.126541. Epub 2020 May 4.

  PMID: 32417634 DERIVED

• Alehagen U, Johansson P, Aaseth J, Alexander J, Surowiec I, Lundstedt-Enkel K, Lundstedt T. Significant Changes in Metabolic Profiles after Intervention with Selenium and Coenzyme Q10 in an Elderly Population. Biomolecules. 2019 Sep 30;9(10):553. doi: 10.3390/biom9100553.

  PMID: 31575091 DERIVED

• Alehagen U, Alexander J, Aaseth J, Larsson A. Decrease in inflammatory biomarker concentration by intervention with selenium and coenzyme Q10: a subanalysis of osteopontin, osteoprotergerin, TNFr1, TNFr2 and TWEAK. J Inflamm (Lond). 2019 Mar 18;16:5. doi: 10.1186/s12950-019-0210-6. eCollection 2019.

  PMID: 30923464 DERIVED

• Alehagen U, Aaseth J, Alexander J, Johansson P. Still reduced cardiovascular mortality 12 years after supplementation with selenium and coenzyme Q10 for four years: A validation of previous 10-year follow-up results of a prospective randomized double-blind placebo-controlled trial in elderly. PLoS One. 2018 Apr 11;13(4):e0193120. doi: 10.1371/journal.pone.0193120. eCollection 2018.

  PMID: 29641571 DERIVED

• Alehagen U, Alexander J, Aaseth J. Supplementation with Selenium and Coenzyme Q10 Reduces Cardiovascular Mortality in Elderly with Low Selenium Status. A Secondary Analysis of a Randomised Clinical Trial. PLoS One. 2016 Jul 1;11(7):e0157541. doi: 10.1371/journal.pone.0157541. eCollection 2016.

  PMID: 27367855 DERIVED

• Alehagen U, Johansson P, Bjornstedt M, Rosen A, Dahlstrom U. Cardiovascular mortality and N-terminal-proBNP reduced after combined selenium and coenzyme Q10 supplementation: a 5-year prospective randomized double-blind placebo-controlled trial among elderly Swedish citizens. Int J Cardiol. 2013 Sep 1;167(5):1860-6. doi: 10.1016/j.ijcard.2012.04.156. Epub 2012 May 23.

  PMID: 22626835 DERIVED

MeSH Terms

Interventions

Selenium; Tuberculin

Intervention Hierarchy (Ancestors)

Chalcogens; Elements; Inorganic Chemicals; Minerals; Antigens, Bacterial; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Antigens; Biological Factors

Study Officials

• Urban Alehagen, PhD, MD

  Inst of Medicine and Health, University Hospital of Linköping, Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: September 28, 2011
• First Posted: September 30, 2011
• Study Start: January 1, 2003
• Primary Completion: February 1, 2010
• Study Completion: February 1, 2010
• Last Updated: October 3, 2011

Record last verified: 2011-09

Locations

SE (1)