Celiac DiseaseNCT04041622
Coeliac Disease in the Nord-Trøndelag Health Study (HUNT)
A study testing Endoscopy and biopsy in people with Celiac Disease, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
In this study, all citizen of Nord-Trøndelag County, Norway, above 20 years of age are invited to participate in a population-based health study, the HUNT study. Blood samples are drawn from the participants and assessed for celiac disease by a serological assay. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Celiac Disease
- What is being tested?
- Endoscopy and biopsy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56,000 participants
- Where
- 1 siteNorway
- Study dates
- 17 Jun 2019to 1 Jul 2024
- Phase
- Interventional
- 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants of the forth round of the HUNT study
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
In this study, all citizen of Nord-Trøndelag County, Norway, above 20 years of age are invited to participate in a population-based health study, the HUNT study. Blood samples are drawn from the participants and assessed for celiac disease by a serological assay. Celiac disease is a chronic inflammatory disease of the small intestine due to dietary gluten in wheat, barley and rye. The diagnosis will be verified through endoscopic assessment and biopsies from the small intestinal mucosa. The aims of the study are 1) to establish the population-based prevalence of celiac disease; 2) to assess the consequences of the disease from patient reported outcomes, symptoms, deficiencies, and co-morbidity; 3) to study possible risk factors and environmental triggering events; 4) to identify genetic predictors and gene-environmental interactions.
- Conditions
- Celiac Disease
- Being tested
- Endoscopy and biopsy
- Keywords
- Prevalence, General population, Diagnosis, Prognosis, Etiology, Genes
- Medical subject headings
- Celiac Disease, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopy and biopsyDiagnostic test
Participants with a positive celiac serology are assessed by endoscopy and duodenal biopsy
| Study group | Role | What they receive |
|---|---|---|
| Endoscopy and biopsy | Other | Participants of the HUNT study with a positive serological assay for celiac disease are invited to attain a diagnostic endoscopy with duodenal biopsies Receives: Diagnostic Test: Endoscopy and biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of celiac disease
the proportion of cases in the general population of Nord-Trøndelag County, Norway
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2019
- Study start17 Jun 2019
- Primary completion1 Jul 2024
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Celiac DiseaseStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All inhabitants of Nord-Trøndelag County, Norway, above 18 years of age are invited to participate
- Masking
- None (open label)
- Enrolment
- 56,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oslo, Oslo University Hospital, Helse Nord-Trøndelag HF, University of Groningen, Karolinska Institutet
- Responsible party
- Sponsor
- Investigators
- Eivind Ness-Jensen, md phd, Principal investigator, NTNU, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04041622
- Sponsor's protocol ID
- 2017/924
- Status last verified
- May 2025
- First submitted
- 30 Jul 2019
- Last updated
- 25 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lukina P, Andersen IL, Eggen PT, Mjones PG, Ronne E, Bolstad N, Klaasen RA, Warren DJ, Iversen R, Hveem K, Bernklev T, Jelsness-Jorgensen LP, Pedersen L, Jonkers I, Lagergren P, Sollid LM, Lundin K, Ness-Jensen E. Coeliac disease in the Trondelag Health Study (HUNT), Norway, a population-based cohort of coeliac disease patients. BMJ Open. 2024 Jan 9;14(1):e077131. doi: 10.1136/bmjopen-2023-077131.
PubMed 38195172
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coeliac Disease in the Nord-Trøndelag Health Study (HUNT)
- ClinicalTrials.gov ID
- NCT04041622
- Acronym / sponsor ID
- 2017/924
- Conditions
- Celiac Disease
- Keywords
- Prevalence, General population, Diagnosis, Prognosis, Etiology, Genes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56,000 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- University of Oslo, Oslo University Hospital, Helse Nord-Trøndelag HF, University of Groningen, Karolinska Institutet
- Study start
- 17 Jun 2019 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 1 Aug 2019 (actual)
- 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.
In this study, all citizen of Nord-Trøndelag County, Norway, above 20 years of age are invited to participate in a population-based health study, the HUNT study. Blood samples are drawn from the participants and assessed for celiac disease by a serological assay. Celiac disease is a chronic inflammatory disease of the small intestine due to dietary gluten in wheat, barley and rye. The diagnosis will be verified through endoscopic assessment and biopsies from the small intestinal mucosa. The aims of the study are 1) to establish the population-based prevalence of celiac disease; 2) to assess the consequences of the disease from patient reported outcomes, symptoms, deficiencies, and co-morbidity; 3) to study possible risk factors and environmental triggering events; 4) to identify genetic predictors and gene-environmental interactions.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All inhabitants of Nord-Trøndelag County, Norway, above 18 years of age are invited to participate
| Arm | Type | Receives |
|---|---|---|
| Endoscopy and biopsy | Other | Diagnostic Test: Endoscopy and biopsyParticipants of the HUNT study with a positive serological assay for celiac disease are invited to attain a diagnostic endoscopy with duodenal biopsies |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participants of the forth round of the HUNT study
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endoscopy and biopsyParticipants with a positive celiac serology are assessed by endoscopy and duodenal biopsy | Diagnostic test | Endoscopy and biopsy |
Primary outcome
Prevalence of celiac disease
Time frame: 1 year
the proportion of cases in the general population of Nord-Trøndelag County, Norway
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2025.
- Derived from this study: PubMed 38195172Lukina P, Andersen IL, Eggen PT, Mjones PG, Ronne E, Bolstad N, Klaasen RA, Warren DJ, Iversen R, Hveem K, Bernklev T, Jelsness-Jorgensen LP, Pedersen L, Jonkers I, Lagergren P, Sollid LM, Lundin K, Ness-Jensen E. Coeliac disease in the Trondelag Health Study (HUNT), Norway, a population-based cohort of coeliac disease patients. BMJ Open. 2024 Jan 9;14(1):e077131. doi: 10.1136/bmjopen-2023-077131.
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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.
Eivind Ness-Jensen, md phd principal investigator
NTNU, Norwegian University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopy and biopsy in people with Celiac Disease, run by Norwegian University of Science and Technology at 1 site in Norway.
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 1 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: finished, as of the sponsor's last update on 25 May 2025. 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 Norway. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of celiac disease (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04041622, which also lists 1 linked publication.
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 25 May 2025.