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.
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||18 Years and Over|
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Norwegian University of Science and Technology|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Eivind Ness-Jensen, md phd|
|Principal Investigator Affiliation||NTNU, Norwegian University of Science and Technology|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
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
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Levanger Hospital, Nord-Trøndelag Hospital Trust
Eivind Ness-Jensen, md phd
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