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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02720809
Other study ID # H-15017277
Secondary ID
Status Not yet recruiting
Phase N/A
First received March 22, 2016
Last updated March 25, 2016
Start date May 2016
Est. completion date October 2017

Study information

Verified date March 2016
Source Glostrup University Hospital, Copenhagen
Contact Allan Linneberg, MD, PhD
Phone +45 38633260
Email allan.linneberg@regionh.dk
Is FDA regulated No
Health authority Denmark: Ethics Committee
Study type Observational

Clinical Trial Summary

Health2016 is a general population cross-sectional study aimed at completing af monitoring program for monitoring chronic disease and risk factors in the period 2006 to 2016. Similar studies have been performed in 2006, 2010, and 2013.


Description:

A random sample of 18-69 year-olds living in 10 municipalities in the Capital Region of Denmark is invited to a health examination including measurements of anthropometry, lifestyles, symptoms and diagnoses of diseases, blood pressure, resting heart rate, muscle strength, fitness, lung function, allergy tests, and biochemistry (lipids, liver and kidney function, vitamin D status, salt excretion, iodine status). Trends in these parameters over time will be assessed.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 1500
Est. completion date October 2017
Est. primary completion date August 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 69 Years
Eligibility Inclusion Criteria: General population sample randomly selected from persons living in 10 municipalities in the Capital Region of Denmark. Age 18-69 years. Danish citizenship, born in Denmark

Exclusion Criteria:

- pregnancy

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional


Locations

Country Name City State
Denmark Research Centre for Prevention and Health Copenhagen Glostrup

Sponsors (1)

Lead Sponsor Collaborator
Glostrup University Hospital, Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in micronutrient status from 2006 to 2016 Serum 25-OH Vitamin D status (nmol/l) in serum from 2006 to 2016 10 years No
Secondary Change in HbA1C from 2006 to 2016 Changes in HbA1C from 2006 to 2016 10 No
Secondary Change in allergic respiratory disease from 2006 to 2016 Changes in prevalence of skin prick test reactivity to inhalant allergens 10 years No
Secondary Change in prevalence of hypertension from 2006 to 2016 Blood pressure above 140/90 or treatment for hypertension 10 years No
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