Prospective Study of Undiagnosed Celiac Disease
Primary Purpose
Celiac Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dietary instruction
Sponsored by
About this trial
This is an interventional diagnostic trial for Celiac Disease
Eligibility Criteria
Inclusion Criteria:
- At least 60 years old
- Male and female
Retrospective testing for celiac disease was done on previously stored serum. Contacting specific individuals for inclusion into study
Sites / Locations
- Mayo Clinic in Rochester
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Dietary instruction on Gluten Free Diet
Arm Description
Outcomes
Primary Outcome Measures
Understanding the impact of undiagnosed celiac disease and the potential benefits of diagnosis
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01317914
Brief Title
Prospective Study of Undiagnosed Celiac Disease
Official Title
Epidemiology of Celiac Disease: A Prospective Study of Undiagnosed Celiac Disease in the Community
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
April 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Celiac Disease
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dietary instruction on Gluten Free Diet
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Dietary instruction
Intervention Description
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.
Primary Outcome Measure Information:
Title
Understanding the impact of undiagnosed celiac disease and the potential benefits of diagnosis
Description
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.
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
At least 60 years old
Male and female
Retrospective testing for celiac disease was done on previously stored serum. Contacting specific individuals for inclusion into study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph Murray, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
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Prospective Study of Undiagnosed Celiac Disease
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