Micronutrient DeficiencyNCT02720809
Health2016: Monitoring Chronic Disease and Risk Factors in the General Population
An observational study of Micronutrient Deficiency and Cardiovascular Disease, run by Glostrup University Hospital, Copenhagen at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Micronutrient Deficiency, Cardiovascular Disease, Allergy
- How many people
- 1,500 participants
- Where
- 1 siteDenmark
- Study dates
- May 2016to Oct 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: General population sample randomly selected from persons living in 10 municipalities in the Capital Region of Denmark. Age 18-69 years.
Who may be able to join
None listed.
Who cannot join
- pregnancy
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Research Centre for Prevention and Health
Copenhagen, Glostrup, DK-2600
About this study
Official title: Helbred2016: Monitorering af Kroniske Sygdomme og Risikofaktorer i Befolkningen
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.
Read the detailed 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.
- Keywords
- micronutrients, blood pressure, allergy, lung function
- Medical subject headings
- Cardiovascular Diseases, Hypersensitivity, Respiration Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in micronutrient status from 2006 to 2016
Serum 25-OH Vitamin D status (nmol/l) in serum from 2006 to 2016
Measured: 10 years
Secondary outcomes (3)
Change in HbA1C from 2006 to 2016
Changes in HbA1C from 2006 to 2016
Measured: 10
Change in allergic respiratory disease from 2006 to 2016
Changes in prevalence of skin prick test reactivity to inhalant allergens
Measured: 10 years
Change in prevalence of hypertension from 2006 to 2016
Blood pressure above 140/90 or treatment for hypertension
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2016 (estimated)
- Study startMay 2016
- Primary completionAug 2017 (estimated)
- Study completionOct 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Micronutrient DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Glostrup University Hospital, Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Allan Linneberg, Glostrup University Hospital, Copenhagen
- Investigators
- Allan Linneberg, MD, PhD, Principal investigator, Center for Health, The Capital Region of Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02720809
- Sponsor's protocol ID
- H-15017277
- Status last verified
- Mar 2016
- First submitted
- 22 Mar 2016
- Last updated
- 28 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Helbred2016: Monitorering af Kroniske Sygdomme og Risikofaktorer i Befolkningen
- ClinicalTrials.gov ID
- NCT02720809
- Acronym / sponsor ID
- H-15017277
- Keywords
- micronutrients, blood pressure, allergy, lung function
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Glostrup University Hospital, CopenhagenUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Aug 2017 (estimated)
- Study completion
- Oct 2017 (estimated)
- First posted
- 28 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- General population sample randomly selected from persons living in 10 municipalities in the Capital Region of Denmark. Age 18-69 years.
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in micronutrient status from 2006 to 2016
Time frame: 10 years
Serum 25-OH Vitamin D status (nmol/l) in serum from 2006 to 2016
3 secondary outcomes
Change in HbA1C from 2006 to 2016
Time frame: 10
Change in allergic respiratory disease from 2006 to 2016
Time frame: 10 years
Change in prevalence of hypertension from 2006 to 2016
Time frame: 10 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Allan Linneberg, MD, PhD principal investigator
Center for Health, The Capital Region of Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Micronutrient Deficiency and Cardiovascular Disease, run by Glostrup University Hospital, Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Allan Linneberg, MD, PhD (+45 38633260, allan.linneberg@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in micronutrient status from 2006 to 2016 (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2016.