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Impact of the Diagnosis of Celiac Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01145287
Recruitment Status : Completed
First Posted : June 16, 2010
Last Update Posted : April 21, 2016
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease
Celiac Disease

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.

Study Design

Study Type : Observational
Actual Enrollment : 760 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Impact of the Diagnosis of Celiac Disease
Study Start Date : February 2007
Primary Completion Date : April 2016
Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Celiac Disease
U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. Psychological General Well-Being (PGWB) Index [ Time Frame: 5 years ]
    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 :
  1. healthcare resource utilization [ Time Frame: 5 years ]
    Healthcare resuorce utilization measured as inpatient and outpatient visits and consumption of other medical services in addition to consumption of pharmaceutical agents

  2. Gastrointestinal Symptoms Rating Scale (GSRS) [ Time Frame: 5 years ]
    clinical symptoms are evaluated at diagnosis and after five years on dietary treatment by using structured questionnaire

  3. dietary compliance [ Time Frame: 5 years ]
    self-assessed compliance to the dietary treatment

  4. weight [ Time Frame: 5 years ]
    effect of the dietary treatment in the weight of celiac disease patients

  5. height [ Time Frame: 5 years ]
    effect of the dietary treatment in the height of children with celiac disease

  6. The Short Form (SF-36) Health Survey [ Time Frame: 5 years ]
    Health-related quality of life and self-perceived health are evaluated at diagnosis and after five years on dietary treatment by using structured questionnaire


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01145287


Locations
Finland
Pediatric Research Centre, University of Tampere, Tampere University Hospital
Tampere, Pirkanmaa, Finland, 33014
Sponsors and Collaborators
Tampere University Hospital
University of Tampere
Finnish Celiac Society
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
First Posted: June 16, 2010    Key Record Dates
Last Update Posted: April 21, 2016
Last Verified: April 2016

Keywords provided by Kalle Kurppa, 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