Prospective Study of Undiagnosed Celiac Disease
This study has been completed.
Sponsor:
Mayo Clinic
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01317914
First received: September 23, 2010
Last updated: May 25, 2012
Last verified: May 2012
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | September 23, 2010 | ||||
| Last Updated Date | May 25, 2012 | ||||
| Start Date ICMJE | July 2010 | ||||
| Primary Completion Date | April 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Understanding the impact of undiagnosed celiac disease and the potential benefits of diagnosis [ Time Frame: one year ] [ Designated as safety issue: No ] To understanding the impact of undiagnosed celiac disease and the potential benefits, detection and treatment may have a substantial impact on the health of these subjects and the large numbers of Americans with undiagnosed celiac disease. The outcome measures we will be looking at are Quality of Life, GI Symptoms including diarrhea, constipation, abdominal pain, Tissue Transglutaminase level improvement after 12 weeks on a gluten free diet, bone density, understanding of a gluten free diet. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01317914 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Prospective Study of Undiagnosed Celiac Disease | ||||
| Official Title ICMJE | Epidemiology of Celiac Disease: A Prospective Study of Undiagnosed Celiac Disease in the Community | ||||
| Brief Summary | Direct benefits to the participants, who are diagnosed with celiac disease may be substantial and could include lessening or prevention of GI symptoms, correction of biochemical abnormalities and reduction in risk for malignancies or bone disease which are most common in untreated celiac disease. However, the precise benefit is unknown and the motivation for this proposed study. If these individuals have a positive celiac serology test at the present time there is a high likelihood that they may have celiac disease. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
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| Condition ICMJE | Celiac Disease | ||||
| Intervention ICMJE | Other: Dietary instruction
Subjects subsequently diagnosed with celiac disease will have gluten-free diet instructions given by registered dietitian experienced in the gluten-free diet. Subjects will have follow-up in 3 months time from initial instruction to verify compliance. |
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| Study Arm (s) | Experimental: Dietary instruction on Gluten Free Diet
Intervention: Other: Dietary instruction |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 31 | ||||
| Completion Date | April 2012 | ||||
| Primary Completion Date | April 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Retrospective testing for celiac disease was done on previously stored serum. Contacting specific individuals for inclusion into study |
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| Gender | Both | ||||
| Ages | 60 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01317914 | ||||
| Other Study ID Numbers ICMJE | 10-000178 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Joseph Murray, MD, Mayo Clinic | ||||
| Study Sponsor ICMJE | Mayo Clinic | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Mayo Clinic | ||||
| Verification Date | May 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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