Treatment of Screen-detected Celiac Disease

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Kalle Kurppa, Tampere University Hospital

ClinicalTrials.gov Identifier:

NCT01116505

First received: May 3, 2010

Last updated: August 24, 2012

Last verified: August 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

May 3, 2010

Last Updated Date

August 24, 2012

Start Date ^ICMJE

August 2008

Primary Completion Date

July 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Small-bowel mucosal morphology and inflammation [ Time Frame: One year ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01116505 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Endomysial antibodies [ Time Frame: one year ] [ Designated as safety issue: No ]
Tissue transglutaminase antibodies [ Time Frame: one year ] [ Designated as safety issue: No ]
Antibodies to deamidated gliadin [ Time Frame: one year ] [ Designated as safety issue: No ]
Intestinal tissue transglutaminase-specific IgA deposits [ Time Frame: one year ] [ Designated as safety issue: No ]
Bone mineral density [ Time Frame: one year ] [ Designated as safety issue: No ]
Body composition [ Time Frame: one year ] [ Designated as safety issue: No ]
Health-related quality of life [ Time Frame: one year ] [ Designated as safety issue: No ]
Laboratory parameters [ Time Frame: one year ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Endomysial antibodies [ Time Frame: one year ] [ Designated as safety issue: No ]
tissue transglutaminase antibodies [ Time Frame: one year ] [ Designated as safety issue: No ]
antibodies to deamitated gliadin [ Time Frame: one year ] [ Designated as safety issue: No ]
intestinal tissue transglutaminase-specific IgA deposits [ Time Frame: one year ] [ Designated as safety issue: No ]
bone mineral density [ Time Frame: one year ] [ Designated as safety issue: No ]
body composition [ Time Frame: one year ] [ Designated as safety issue: No ]
health-related quality of life [ Time Frame: one year ] [ Designated as safety issue: No ]
laboratory parameters [ Time Frame: one year ] [ Designated as safety issue: No ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Treatment of Screen-detected Celiac Disease

Official Title ^ICMJE

Treatment of Screen-detected Celiac Disease in Adults

Brief Summary

The main purpose of this study is to evaluate the natural history of celiac disease in asymptomatic, screen-detected subjects having positive endomysial antibodies and the effects of an intervention with a gluten-free diet. The investigators hypothesize that these subjects may have decreased general health and benefit of the dietary treatment regardless of the small-bowel mucosal structure.

Detailed Description

Asymptomatic, endomysial-antibody positive adults will be randomized to either continue with a normal, gluten-containing diet or start an intervention with a gluten-free diet irrespective of the small-bowel mucosal morphology. Several celiac-disease associated histological, serological and clinical markers will be evaluated both at baseline and after one year on trial.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic

Condition ^ICMJE

Celiac Disease

Intervention ^ICMJE

Dietary Supplement: Gluten-free diet

gluten-containing cereals removed from diet

Study Arm (s)

No Intervention: gluten-containing diet
Active Comparator: Active comparator, gluten-free diet
Intervention: Dietary Supplement: Gluten-free diet

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

August 2012

Primary Completion Date

July 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Positive endomysial antibodies
Adults

Exclusion Criteria:

Previous celiac disease diagnosis
Significant clinical symptoms
Suspicion of any serious celiac disease-associated complication
Suspected or diagnosed severe illness other than celiac disease
Consuming oral corticosteroids or immune suppressants
Marked laboratory abnormalities

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Finland

Administrative Information

NCT Number ^ICMJE

NCT01116505

Other Study ID Numbers ^ICMJE

R07122

Has Data Monitoring Committee

Responsible Party

Kalle Kurppa, Tampere University Hospital

Study Sponsor ^ICMJE

Tampere University Hospital

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Katri Kaukinen, MD

University of Tampere, Tampere University hospital

Information Provided By

Tampere University Hospital

Verification Date

August 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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