Treatment of Screen-detected Celiac Disease
This study has been completed.
Sponsor:
Tampere University Hospital
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
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Celiac Disease |
Dietary Supplement: Gluten-free diet |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | Treatment of Screen-detected Celiac Disease in Adults |
Resource links provided by NLM:
Further study details as provided by Tampere University Hospital:
Primary Outcome Measures:
- Small-bowel mucosal morphology and inflammation [ Time Frame: One year ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ]
| Enrollment: | 40 |
| Study Start Date: | August 2008 |
| Study Completion Date: | August 2012 |
| Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| No Intervention: gluten-containing diet | |
| Active Comparator: Active comparator, gluten-free diet |
Dietary Supplement: Gluten-free diet
gluten-containing cereals removed from diet
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01116505
Locations
| Finland | |
| Pediatric Research Centre, Tampere University Hospital and University of Tampere | |
| Tampere, Pirkanmaa, Finland, 33014 | |
Sponsors and Collaborators
Tampere University Hospital
Investigators
| Principal Investigator: | Katri Kaukinen, MD | University of Tampere, Tampere University hospital |
More Information
No publications provided
| Responsible Party: | Kalle Kurppa, M.D, Ph.D, Pediatrician, Tampere University Hospital |
| ClinicalTrials.gov Identifier: | NCT01116505 History of Changes |
| Other Study ID Numbers: | R07122 |
| Study First Received: | May 3, 2010 |
| Last Updated: | August 24, 2012 |
| Health Authority: | Finland: Ministry of Social Affairs and Health |
Keywords provided by Tampere University Hospital:
|
Celiac disease Endomysial antibodies Gluten-free diet |
Screen-detected Asymptomatic Bone mineral density |
Additional relevant MeSH terms:
|
Celiac Disease Malabsorption Syndromes Intestinal Diseases |
Gastrointestinal Diseases Digestive System Diseases Metabolic Diseases |
ClinicalTrials.gov processed this record on May 19, 2013