Cohort of Swedish Men

Cardiovascular Diseases Clinical Trial

— COSM  

Official title:

Cohort of Swedish Men

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01127711
• Other study ID #: 1706/2010-631-2
• Status: Completed
• Phase: N/A
• First received: May 20, 2010
• Last updated: February 27, 2014
• Start date: September 1997

Study information

• Verified date: February 2014
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Ethical Rewiev BoardSweden: The Swedish Data Inspection Board
• Study type: Observational

Clinical Trial Summary

The Cohort of Swedish Men began in 1997, when all men born between 1918 and 1952 and residing in two counties in central Sweden received a questionnaire including about 350 items concerning diet and other lifestyle factors. A second questionnaire was sent out in 2008-09.

Description:

The Cohort of Swedish Men was established in 1997, when all men born between 1918 and 1952 and residing in Västmanland and Örebro counties in central Sweden received a questionnaire concerning diet and other lifestyle factors. Of the 100,303 eligible men, 48,850 (49%) responded to the questionnaire. The questionnaire included items about diet, physical activity, medical history, and lifestyle factors such as cigarette smoking history and use of dietary supplements.

During 2008-09, the exposure information was updated and extended by sending out two new questionnaires - one questionnaire on health including several signs of symptoms, sleeping, social relations etc (2008) and one on diet, dietary supplement use, and lifestyle factors (2009). Majority of questions in the questionnaires have been validated.

Incident cases of cancer are ascertained by record linkages of the study population with the National Swedish Cancer Register and the Regional Cancer Registers. Cardiovascular and other diseases as well as surgeries and causes of death are identified by linkage to the National Inpatient and other registries at the Swedish Board of Health and Welfare. Ascertainment of cancer cases and other diseases is almost 100% complete. Dates of deaths are ascertained through the Swedish Death Register (100% complete), and information on date of moving out of the study area is obtained by linkage with the Swedish Population Register.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48850
• Est. primary completion date: December 1997
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 45 Years to 79 Years

Eligibility

Inclusion Criteria:

• All men born between 1918 and 1952, living in central Sweden

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cancers
• Cardiovascular Diseases
• Cataract
• Digestive System Diseases
• Fractures
• Gastrointestinal Diseases
• Osteoporosis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prostate cancer		1997-2010	No
Primary	Pancreatic cancer		1997-2010	No
Primary	Stomach cancer		1997-2010	No
Primary	Cataract		1997-2010	No
Primary	LUTS (Lower urinary tract symptom)		1997-2010	No
Primary	Cardiovascular Diseases		1997-2010	No
Primary	Mortality		1997-2010	No
Primary	Colorectal Cancer		1997-2010	No
Primary	Bladder cancer		1997-2010	No
Primary	Fractures, hip fractures		1997-2014	No

External Links

•   Unit of Nutritional Epidemiology