Coeliac Disease in the Nord-Trøndelag Health Study (HUNT)

NCT ID: NCT04041622

Last Updated: 2025-05-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

56000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-17

Study Completion Date

2024-07-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Celiac Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

All inhabitants of Nord-Trøndelag County, Norway, above 18 years of age are invited to participate
Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Endoscopy and biopsy

Participants of the HUNT study with a positive serological assay for celiac disease are invited to attain a diagnostic endoscopy with duodenal biopsies

Group Type OTHER

Endoscopy and biopsy

Intervention Type DIAGNOSTIC_TEST

Participants with a positive celiac serology are assessed by endoscopy and duodenal biopsy

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Endoscopy and biopsy

Participants with a positive celiac serology are assessed by endoscopy and duodenal biopsy

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Participants of the forth round of the HUNT study

Exclusion Criteria

* None
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Oslo

OTHER

Sponsor Role collaborator

Oslo University Hospital

OTHER

Sponsor Role collaborator

Helse Nord-Trøndelag HF

OTHER

Sponsor Role collaborator

University of Groningen

OTHER

Sponsor Role collaborator

Karolinska Institutet

OTHER

Sponsor Role collaborator

Norwegian University of Science and Technology

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Eivind Ness-Jensen, md phd

Role: PRINCIPAL_INVESTIGATOR

NTNU, Norwegian University of Science and Technology

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Levanger Hospital, Nord-Trøndelag Hospital Trust

Levanger, , Norway

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Norway

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 38195172 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2017/924

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Gluten Challenge in Celiac Disease
NCT02464150 COMPLETED NA
Gluten Reduction and Risk of Celiac Disease
NCT04593888 ACTIVE_NOT_RECRUITING NA
Celiac Disease Prevention
NCT00617838 UNKNOWN NA
Serum Markers in Gluten Challenge
NCT00931892 COMPLETED NA