Impact of the Diagnosis of Celiac Disease

NCT ID: NCT01145287

Last Updated: 2016-04-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

760 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-02-28

Study Completion Date

2016-04-30

Brief Summary

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The main purpose of this study is to assess the impact of the diagnosis of celiac disease on general health, healthcare resource utilization, quality of life and lifestyle. We hypothesize that diagnosis and subsequent dietary treatment may have positive impact on these variables.

Detailed Description

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All new members with biopsy-proven celiac disease joining the Finnish Celiac Society will be categorized in three groups according to symptoms and signs leading to the diagnosis as classical symptoms, extraintestinal symptoms and screen-detected, the latest being further divided to those presenting with symptoms and those who are totally asymptomatic. Several parameters assessing general health and well-being, quality of life and healthcare resource utilization are evaluated at baseline and after one and five years on trial. Quality of life is compared to that of non-celiac controls.

Conditions

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Celiac Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* diagnosis within one year
* biopsy-proven diagnosis

Exclusion Criteria

* Celiac disease diagnosis previously than within one year
* No biopsy-proven diagnosis
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tampere University

OTHER

Sponsor Role collaborator

Finnish Celiac Society

UNKNOWN

Sponsor Role collaborator

Tampere University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Kalle Kurppa

M.D, pH.D, Pediatrician

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Pediatric Research Centre, University of Tampere, Tampere University Hospital

Tampere, Pirkanmaa, Finland

Site Status

Countries

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Finland

References

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Ukkola A, Kurppa K, Collin P, Huhtala H, Forma L, Kekkonen L, Maki M, Kaukinen K. Use of health care services and pharmaceutical agents in coeliac disease: a prospective nationwide study. BMC Gastroenterol. 2012 Sep 27;12:136. doi: 10.1186/1471-230X-12-136.

Reference Type DERIVED
PMID: 23016889 (View on PubMed)

Kinos S, Kurppa K, Ukkola A, Collin P, Lahdeaho ML, Huhtala H, Kekkonen L, Maki M, Kaukinen K. Burden of illness in screen-detected children with celiac disease and their families. J Pediatr Gastroenterol Nutr. 2012 Oct;55(4):412-6. doi: 10.1097/MPG.0b013e31825f18ff.

Reference Type DERIVED
PMID: 22614110 (View on PubMed)

Ukkola A, Maki M, Kurppa K, Collin P, Huhtala H, Kekkonen L, Kaukinen K. Changes in body mass index on a gluten-free diet in coeliac disease: a nationwide study. Eur J Intern Med. 2012 Jun;23(4):384-8. doi: 10.1016/j.ejim.2011.12.012. Epub 2012 Jan 28.

Reference Type DERIVED
PMID: 22560391 (View on PubMed)

Ukkola A, Maki M, Kurppa K, Collin P, Huhtala H, Kekkonen L, Kaukinen K. Patients' experiences and perceptions of living with coeliac disease - implications for optimizing care. J Gastrointestin Liver Dis. 2012 Mar;21(1):17-22.

Reference Type DERIVED
PMID: 22457855 (View on PubMed)

Other Identifiers

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Burden-1

Identifier Type: -

Identifier Source: org_study_id

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