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
  Purpose

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.


Condition Intervention
Celiac Disease
Other: Dietary instruction

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Epidemiology of Celiac Disease: A Prospective Study of Undiagnosed Celiac Disease in the Community

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • 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.


Enrollment: 31
Study Start Date: July 2010
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dietary instruction on Gluten Free Diet 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.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01317914

Locations
United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Joseph Murray, MD Mayo Clinic
  More Information

No publications provided

Responsible Party: Joseph Murray, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01317914     History of Changes
Other Study ID Numbers: 10-000178
Study First Received: September 23, 2010
Last Updated: May 25, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Celiac Disease
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases

ClinicalTrials.gov processed this record on April 17, 2014