Clinical trial NCT01145287: Impact of the Diagnosis of Celiac Disease
Official title: Impact of the Diagnosis of Celiac Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Celiac Disease
Keywords: Celiac disease
Gluten-free diet
Screen-detected
Asymptomatic
Quality of life
Self-perceived health
Healthcare resource utilization
Lead sponsor: Tampere University Hospital
Sponsor class: OTHER
Collaborators: name: Tampere University
name: Finnish Celiac Society
First posted: 2010-06-16
Enrollment: 760
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All new members with biopsy-proven celiac disease joining the Finnish Celiac Society.

Brief summary: 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: 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 criteria: Inclusion Criteria:

* diagnosis within one year
* biopsy-proven diagnosis

Exclusion Criteria:

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

Primary outcomes:
measure: Psychological General Well-Being (PGWB) Index
timeFrame: 5 years
Secondary outcomes:
measure: healthcare resource utilization
timeFrame: 5 years
measure: Gastrointestinal Symptoms Rating Scale (GSRS)
timeFrame: 5 years
measure: dietary compliance
timeFrame: 5 years
measure: weight
timeFrame: 5 years
measure: height
timeFrame: 5 years
measure: The Short Form (SF-36) Health Survey
timeFrame: 5 years
Other outcomes:
Locations:
city: Tampere
country: Finland
facility: Pediatric Research Centre, University of Tampere, Tampere University Hospital
state: Pirkanmaa
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.