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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04041622
Other study ID # 2017/924
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date June 17, 2019
Est. completion date July 2024

Study information

Verified date January 2024
Source Norwegian University of Science and Technology
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

In this study, all citizen of Nord-Trøndelag County, Norway, above 18 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 56000
Est. completion date July 2024
Est. primary completion date July 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Participants of the forth round of the HUNT study Exclusion Criteria: - None

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Endoscopy and biopsy
Participants with a positive celiac serology are assessed by endoscopy and duodenal biopsy

Locations

Country Name City State
Norway Levanger Hospital, Nord-Trøndelag Hospital Trust Levanger

Sponsors (7)

Lead Sponsor Collaborator
Norwegian University of Science and Technology Helse Nord-Trøndelag HF, Karolinska Institutet, Norsk cøliakiforening, Oslo University Hospital, University of Groningen, University of Oslo

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary Prevalence of celiac disease the proportion of cases in the general population of Nord-Trøndelag County, Norway 1 year
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