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Prospective Study of Undiagnosed Celiac Disease

This study has been completed.
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01317914
First received: September 23, 2010
Last updated: May 25, 2012
Last verified: May 2012

September 23, 2010
May 25, 2012
July 2010
April 2012   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01317914 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Prospective Study of Undiagnosed Celiac Disease
Epidemiology of Celiac Disease: A Prospective Study of Undiagnosed Celiac Disease in the Community

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.

Not Provided
Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Celiac Disease
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.
Experimental: Dietary instruction on Gluten Free Diet
Intervention: Other: Dietary instruction
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
31
April 2012
April 2012   (final data collection date for primary outcome measure)

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

Both
60 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01317914
10-000178
No
Joseph Murray, MD, Mayo Clinic
Mayo Clinic
Not Provided
Principal Investigator: Joseph Murray, MD Mayo Clinic
Mayo Clinic
May 2012

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