Impact of the Diagnosis of Celiac Disease

This study is currently recruiting participants.

Verified August 2012 by Tampere University Hospital

Sponsor:

Collaborators:

University of Tampere

Finnish Celiac Society

Information provided by (Responsible Party):

Kalle Kurppa, Tampere University Hospital

ClinicalTrials.gov Identifier:

NCT01145287

First received: June 7, 2010

Last updated: August 24, 2012

Last verified: August 2012

History of Changes

Purpose

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.

Condition
Celiac Disease

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Impact of the Diagnosis of Celiac Disease

Resource links provided by NLM:

Genetics Home Reference related topics: celiac disease

MedlinePlus related topics: Celiac Disease

U.S. FDA Resources

Further study details as provided by Tampere University Hospital:

Primary Outcome Measures:

Psychological General Well-Being (PGWB) Index [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Health-related quality of life and self-perceived health are evaluated at diagnosis and after five years on dietary treatment by using structured questionnaire

Secondary Outcome Measures:

healthcare resource utilization [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Healthcare resuorce utilization measured as inpatient and outpatient visits and consumption of other medical services in addition to consumption of pharmaceutical agents
Gastrointestinal Symptoms Rating Scale (GSRS) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
clinical symptoms are evaluated at diagnosis and after five years on dietary treatment by using structured questionnaire
dietary compliance [ Time Frame: 5 years ] [ Designated as safety issue: No ]
self-assessed compliance to the dietary treatment
weight [ Time Frame: 5 years ] [ Designated as safety issue: No ]
effect of the dietary treatment in the weight of celiac disease patients
height [ Time Frame: 5 years ] [ Designated as safety issue: No ]
effect of the dietary treatment in the height of children with celiac disease
The Short Form (SF-36) Health Survey [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Health-related quality of life and self-perceived health are evaluated at diagnosis and after five years on dietary treatment by using structured questionnaire

Estimated Enrollment:	1100
Study Start Date:	February 2007
Estimated Study Completion Date:	September 2013
Estimated Primary Completion Date:	September 2013 (Final data collection date for primary outcome measure)

Detailed Description:

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.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

All new members with biopsy-proven celiac disease joining the Finnish Celiac Society.

Criteria

Inclusion Criteria:

diagnosis within one year
biopsy-proven diagnosis

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01145287

Locations

Finland
Pediatric Research Centre, University of Tampere, Tampere University Hospital	Recruiting
Tampere, Pirkanmaa, Finland, 33014
Contact: Kalle Kurppa, MD +3583311611 kalle.kurppa@uta.fi

Sponsors and Collaborators

Tampere University Hospital

University of Tampere

Finnish Celiac Society

More Information

No publications provided by Tampere University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Kinos S, Kurppa K, Ukkola A, Collin P, Lähdeaho ML, Huhtala H, Kekkonen L, Mäki 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.

Ukkola A, Mäki 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. Epub 2012 Jan 28.

Ukkola A, Mäki 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.

Responsible Party:	Kalle Kurppa, M.D, pH.D, Pediatrician, Tampere University Hospital
ClinicalTrials.gov Identifier:	NCT01145287 History of Changes
Other Study ID Numbers:	Burden-1
Study First Received:	June 7, 2010
Last Updated:	August 24, 2012
Health Authority:	Finland: Ministry of Social Affairs and Health

Keywords provided by Tampere University Hospital:

Celiac disease
Gluten-free diet
Screen-detected
Asymptomatic

Quality of life
Self-perceived health
Healthcare resource utilization

Additional relevant MeSH terms:

Celiac Disease
Malabsorption Syndromes
Intestinal Diseases

Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases

ClinicalTrials.gov processed this record on May 23, 2013

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