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

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ClinicalTrials.gov Identifier: NCT04041622
Recruitment Status : Recruiting
First Posted : August 1, 2019
Last Update Posted : August 4, 2020
Sponsor:
Collaborators:
University of Oslo
Oslo University Hospital
Levanger Hospital
Karolinska Institutet
University of Groningen
Norsk cøliakiforening
Information provided by (Responsible Party):
Norwegian University of Science and Technology

Brief 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.

Condition or disease Intervention/treatment Phase
Celiac Disease Diagnostic Test: Endoscopy and biopsy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54000 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: All inhabitants of Nord-Trøndelag County, Norway, above 18 years of age are invited to participate
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Coeliac Disease in the Nord-Trøndelag Health Study (HUNT)
Actual Study Start Date : June 17, 2019
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Prevalence of celiac disease [ Time Frame: 1 year ]
    the proportion of cases in the general population of Nord-Trøndelag County, Norway



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Participants of the forth round of the HUNT study

Exclusion Criteria:

  • None

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04041622


Contacts
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Contact: Eivind Ness-Jensen, md phd +47 74019248 eivind.ness-jensen@ntnu.no
Contact: Knut Lundin, md phd knut.lundin@medisin.uio.no

Locations
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Norway
Levanger Hospital, Nord-Trøndelag Hospital Trust Recruiting
Levanger, Norway
Contact: Eivind Ness-Jensen, md phd    +47 74019248    eivind.ness-jensen@ntnu.no   
Sponsors and Collaborators
Norwegian University of Science and Technology
University of Oslo
Oslo University Hospital
Levanger Hospital
Karolinska Institutet
University of Groningen
Norsk cøliakiforening
Investigators
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Principal Investigator: Eivind Ness-Jensen, md phd NTNU, Norwegian University of Science and Technology
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Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT04041622    
Other Study ID Numbers: 2017/924
First Posted: August 1, 2019    Key Record Dates
Last Update Posted: August 4, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Norwegian University of Science and Technology:
Prevalence
General population
Diagnosis
Prognosis
Etiology
Genes
Additional relevant MeSH terms:
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Celiac Disease
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases