Impact of the Diagnosis of Celiac Disease

Celiac Disease Clinical Trial

Official title:

Impact of the Diagnosis of Celiac Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01145287
• Other study ID #: Burden-1
• Status: Completed
• Phase: N/A
• First received: June 7, 2010
• Last updated: April 19, 2016
• Start date: February 2007
• Est. completion date: April 2016

Study information

• Verified date: April 2016
• Source: Tampere University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ministry of Social Affairs and Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 760
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• diagnosis within one year

• biopsy-proven diagnosis

Exclusion Criteria:

• Celiac disease diagnosis previously than within one year

• No biopsy-proven diagnosis

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Celiac Disease

Locations

Country	Name	City	State
Finland	Pediatric Research Centre, University of Tampere, Tampere University Hospital	Tampere	Pirkanmaa

Sponsors (3)

Lead Sponsor	Collaborator
Tampere University Hospital	Finnish Celiac Society, University of Tampere

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Psychological General Well-Being (PGWB) Index	Health-related quality of life and self-perceived health are evaluated at diagnosis and after five years on dietary treatment by using structured questionnaire	5 years	No
Secondary	healthcare resource utilization	Healthcare resuorce utilization measured as inpatient and outpatient visits and consumption of other medical services in addition to consumption of pharmaceutical agents	5 years	No
Secondary	Gastrointestinal Symptoms Rating Scale (GSRS)	clinical symptoms are evaluated at diagnosis and after five years on dietary treatment by using structured questionnaire	5 years	No
Secondary	dietary compliance	self-assessed compliance to the dietary treatment	5 years	No
Secondary	weight	effect of the dietary treatment in the weight of celiac disease patients	5 years	No
Secondary	height	effect of the dietary treatment in the height of children with celiac disease	5 years	No
Secondary	The Short Form (SF-36) Health Survey	Health-related quality of life and self-perceived health are evaluated at diagnosis and after five years on dietary treatment by using structured questionnaire	5 years	No