NCT01145287

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
760

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2007

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

June 7, 2010

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 16, 2010

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

April 21, 2016

Status Verified

April 1, 2016

Enrollment Period

9.2 years

First QC Date

June 7, 2010

Last Update Submit

April 19, 2016

Conditions

Celiac Disease

Keywords

Celiac diseaseGluten-free dietScreen-detectedAsymptomaticQuality of lifeSelf-perceived healthHealthcare resource utilization

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (6)

  • healthcare resource utilization

    5 years

  • Gastrointestinal Symptoms Rating Scale (GSRS)

    5 years

  • dietary compliance

    5 years

  • weight

    5 years

  • height

    5 years

  • +1 more secondary outcomes

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • diagnosis within one year
  • biopsy-proven diagnosis

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pediatric Research Centre, University of Tampere, Tampere University Hospital

Tampere, Pirkanmaa, 33014, Finland

Location

Related Publications (4)

  • 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.

    PMID: 23016889DERIVED

  • 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.

    PMID: 22614110DERIVED

  • 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.

    PMID: 22560391DERIVED

  • 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.

    PMID: 22457855DERIVED

MeSH Terms

Conditions

Celiac Disease

Condition Hierarchy (Ancestors)

Malabsorption SyndromesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D, pH.D, Pediatrician

Study Record Dates

First Submitted

June 7, 2010

First Posted

June 16, 2010

Study Start

February 1, 2007

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

April 21, 2016

Record last verified: 2016-04

Locations

FI(1)