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

May 21, 2025 updated by: Norwegian University of Science and Technology
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

56000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Levanger, Norway
        • Levanger Hospital, Nord-Trøndelag Hospital Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Participants of the forth round of the HUNT study

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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
Diagnostic test: Endoscopy and biopsy
Participants with a positive celiac serology are assessed by endoscopy and duodenal biopsy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of celiac disease
Time Frame: 1 year
the proportion of cases in the general population of Nord-Trøndelag County, Norway
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Norwegian University of Science and Technology

Collaborators

University of Oslo
Karolinska Institutet
Oslo University Hospital
Helse Nord-Trøndelag HF
University of Groningen

Investigators

  • Principal Investigator: Eivind Ness-Jensen, md phd, NTNU, Norwegian University of Science and Technology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 17, 2019

Primary Completion (Actual)

July 1, 2024

Study Completion (Actual)

July 1, 2024

Study Registration Dates

First Submitted

July 30, 2019

First Submitted That Met QC Criteria

July 31, 2019

First Posted (Actual)

August 1, 2019

Study Record Updates

Last Update Posted (Actual)

May 25, 2025

Last Update Submitted That Met QC Criteria

May 21, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017/924

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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