NCT01317914

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 23, 2010

Completed
6 months until next milestone

First Posted

Study publicly available on registry

March 17, 2011

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

October 2, 2017

Status Verified

September 1, 2017

Enrollment Period

1.8 years

First QC Date

September 23, 2010

Last Update Submit

September 28, 2017

Conditions

Celiac Disease

Outcome Measures

Primary Outcomes (1)

  • 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.

    one year

Study Arms (1)

Dietary instruction on Gluten Free Diet

EXPERIMENTAL
Other: Dietary instruction

Interventions

Dietary instructionOTHER

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.

Dietary instruction on Gluten Free Diet

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • At least 60 years old
  • Male and female

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Celiac Disease

Condition Hierarchy (Ancestors)

Malabsorption SyndromesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Joseph Murray, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

September 23, 2010

First Posted

March 17, 2011

Study Start

July 1, 2010

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

October 2, 2017

Record last verified: 2017-09

Locations

US(1)