Back to resultsCoeliac Disease in the Nord-Trøndelag Health Study (HUNT)
Primary Purpose
Celiac Disease
Status
Recruiting
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Endoscopy and biopsy
Sponsored by
About this trial
This is an interventional screening trial for Celiac Disease focused on measuring Prevalence, General population, Diagnosis, Prognosis, Etiology, Genes
Eligibility Criteria
Inclusion Criteria:
- Participants of the forth round of the HUNT study
Exclusion Criteria:
- None
Sites / Locations
- Levanger Hospital, Nord-Trøndelag Hospital TrustRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Endoscopy and biopsy
Arm Description
Participants of the HUNT study with a positive serological assay for celiac disease are invited to attain a diagnostic endoscopy with duodenal biopsies
Outcomes
Primary Outcome Measures
Prevalence of celiac disease
the proportion of cases in the general population of Nord-Trøndelag County, Norway
Secondary Outcome Measures
Full Information
NCT ID
NCT04041622
First Posted
July 30, 2019
Last Updated
September 16, 2022
Sponsor
Norwegian University of Science and Technology
Collaborators
University of Oslo, Oslo University Hospital, Helse Nord-Trøndelag HF, Karolinska Institutet, University of Groningen, Norsk cøliakiforening
1. Study Identification
Unique Protocol Identification Number
NCT04041622
Brief Title
Coeliac Disease in the Nord-Trøndelag Health Study (HUNT)
Official Title
Coeliac Disease in the Nord-Trøndelag Health Study (HUNT)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 17, 2019 (Actual)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
July 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology
Collaborators
University of Oslo, Oslo University Hospital, Helse Nord-Trøndelag HF, Karolinska Institutet, University of Groningen, Norsk cøliakiforening
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Celiac Disease
Keywords
Prevalence, General population, Diagnosis, Prognosis, Etiology, Genes
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
All inhabitants of Nord-Trøndelag County, Norway, above 18 years of age are invited to participate
Masking
None (Open Label)
Allocation
N/A
Enrollment
54000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Endoscopy and biopsy
Arm Type
Other
Arm Description
Participants of the HUNT study with a positive serological assay for celiac disease are invited to attain a diagnostic endoscopy with duodenal biopsies
Intervention Type
Diagnostic Test
Intervention Name(s)
Endoscopy and biopsy
Intervention Description
Participants with a positive celiac serology are assessed by endoscopy and duodenal biopsy
Primary Outcome Measure Information:
Title
Prevalence of celiac disease
Description
the proportion of cases in the general population of Nord-Trøndelag County, Norway
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Participants of the forth round of the HUNT study
Exclusion Criteria:
None
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eivind Ness-Jensen, md phd
Phone
+47 74019248
Email
eivind.ness-jensen@ntnu.no
First Name & Middle Initial & Last Name or Official Title & Degree
Knut Lundin, md phd
Email
knut.lundin@medisin.uio.no
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eivind Ness-Jensen, md phd
Organizational Affiliation
NTNU, Norwegian University of Science and Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Levanger Hospital, Nord-Trøndelag Hospital Trust
City
Levanger
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eivind Ness-Jensen, md phd
Phone
+47 74019248
Email
eivind.ness-jensen@ntnu.no
12. IPD Sharing Statement
Learn more about this trial
Coeliac Disease in the Nord-Trøndelag Health Study (HUNT)
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