Celiac DiseaseNCT01145287
Impact of the Diagnosis of Celiac Disease
An observational study of Celiac Disease, run by Tampere University Hospital at 1 site in Finland.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Celiac Disease
- How many people
- 760 participants
- Where
- 1 siteFinland
- Study dates
- Feb 2007to Apr 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All new members with biopsy-proven celiac disease joining the Finnish Celiac Society.
Who may be able to join
- diagnosis within one year
- biopsy-proven diagnosis
Who cannot join
- Celiac disease diagnosis previously than within one year
- No biopsy-proven diagnosis
Trial locations and contacts
1 site in 1 country.
Finland1 site
Pediatric Research Centre, University of Tampere, Tampere University Hospital
Tampere, Pirkanmaa, 33014
About this study
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.
Read the 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.
- Conditions
- Celiac Disease
- Keywords
- Celiac disease, Gluten-free diet, Screen-detected, Asymptomatic, Quality of life, Self-perceived health, Healthcare resource utilization
- Medical subject headings
- Celiac Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 5 years
Secondary outcomes (6)
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
Measured: 5 years
Gastrointestinal Symptoms Rating Scale (GSRS)
clinical symptoms are evaluated at diagnosis and after five years on dietary treatment by using structured questionnaire
Measured: 5 years
dietary compliance
self-assessed compliance to the dietary treatment
Measured: 5 years
weight
effect of the dietary treatment in the weight of celiac disease patients
Measured: 5 years
height
effect of the dietary treatment in the height of children with celiac disease
Measured: 5 years
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
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2010 (estimated)
- Study startFeb 2007
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Celiac DiseaseStudies of the same condition, open and under way.
- More trials run by Tampere University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 760 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Tampere University, Finnish Celiac Society
- Responsible party
- Principal investigator, Kalle Kurppa, Tampere University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01145287
- Sponsor's protocol ID
- Burden-1
- Status last verified
- Apr 2016
- First submitted
- 7 Jun 2010
- Last updated
- 21 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23016889Kinos 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.
PubMed 22614110Ukkola 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.
PubMed 22560391Ukkola 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.
PubMed 22457855
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Diagnosis of Celiac Disease
- ClinicalTrials.gov ID
- NCT01145287
- Acronym / sponsor ID
- Burden-1
- Conditions
- Celiac Disease
- Keywords
- Celiac disease, Gluten-free diet, Screen-detected, Asymptomatic, Quality of life, Self-perceived health, Healthcare resource utilization
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 760 participants (actual)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Collaborators
- Tampere University, Finnish Celiac Society
- Study start
- Feb 2007
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 16 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All new members with biopsy-proven celiac disease joining the Finnish Celiac Society.
Key inclusion criteria (2 listed)
- diagnosis within one year
- biopsy-proven diagnosis
Key exclusion criteria (2 listed)
- Celiac disease diagnosis previously than within one year
- No biopsy-proven diagnosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
6 secondary outcomes
healthcare resource utilization
Time frame: 5 years
Gastrointestinal Symptoms Rating Scale (GSRS)
Time frame: 5 years
dietary compliance
Time frame: 5 years
weight
Time frame: 5 years
height
Time frame: 5 years
The Short Form (SF-36) Health Survey
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2016.
- Derived from this study: PubMed 23016889Ukkola 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.
- Derived from this study: PubMed 22614110Kinos 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.
- Derived from this study: PubMed 22560391Ukkola 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.
- Derived from this study: PubMed 22457855Ukkola 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Celiac Disease, run by Tampere University Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychological General Well-Being (PGWB) Index (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01145287, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2016.