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

NCT04041622 | Completed

• 1 other identifier: 2017/924
• Study Type: interventional
• Target: 56,000
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

Prevalence; General population; Diagnosis; Prognosis; Etiology; Genes

Outcome Measures

Primary Outcomes (1)

• Prevalence of celiac disease

  the proportion of cases in the general population of Nord-Trøndelag County, Norway

  1 year

Study Arms (1)

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

Diagnostic Test: Endoscopy and biopsy

Interventions

Endoscopy and biopsy DIAGNOSTIC_TEST

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

Endoscopy and biopsy

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants of the forth round of the HUNT study

You may not qualify if:

• None

Sponsors & Collaborators

• Norwegian University of Science and Technology: lead
• University of Oslo: collaborator
• Oslo University Hospital: collaborator
• Helse Nord-Trøndelag HF: collaborator
• University of Groningen: collaborator
• Karolinska Institutet: collaborator

Study Sites (1)

Levanger Hospital, Nord-Trøndelag Hospital Trust

Levanger, Norway

Location

Related Publications (1)

• 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.

  PMID: 38195172 DERIVED

MeSH Terms

Conditions

Celiac Disease; Disease

Interventions

Endoscopy; Biopsy

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Specimen Handling; Investigative Techniques

Study Officials

• Eivind Ness-Jensen, md phd

  NTNU, Norwegian University of Science and Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All inhabitants of Nord-Trøndelag County, Norway, above 18 years of age are invited to participate

Study Record Dates

• First Submitted: July 30, 2019
• First Posted: August 1, 2019
• Study Start: June 17, 2019
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: May 25, 2025

Record last verified: 2025-05

Locations

NO (1)