Detection of Celiac Disease in Patients With Hypothyroidism

December 5, 2014 updated by: Richard Zubarik, University of Vermont
The study evaluates whether hypothyroid patients requiring elevated doses of levothyroxine to maintain a euthyroid state are at increased risk of having celiac disease. It also attempts to determine if there is a threshold level of levothyroxine needed to maintain a euthyroid state in patients with hypothyroidism that should prompt serologic testing for celiac disease.

Study Overview

Status

Completed

Conditions

Detailed Description

This study is looking at whether hypothyroid patients who require above 125 mcg/day (or >1.5mcg/kg/day) of levothyroxine are more likely to have celiac disease than those who require smaller doses. It also looks to see if the prevalence of celiac disease in hypothyroid patients who require elevated doses of levothyroxine is high enough to warrant screening in that population.

Study Type

Observational

Enrollment (Actual)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Vermont
      • Burlington, Vermont, United States, 05405
        • Fletcher Allen Health Care

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with hypothyroidism who take thyroid replacement therapy

Description

Inclusion Criteria:

  • Patients with the diagnosis of hypothyroidism that require thyroid replacement therapy.

Exclusion Criteria:

  • Surgical resection of thyroid tissue, neck irradiation, radioactive iodine therapy, prior medical treatment with lithium, methimazole, propylthiouracil, ethionamide, amiodarone, or sunitinib, prior serologic testing for celiac disease.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
presence of celiac disease
Time Frame: 1 month
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Symptoms associated with celiac disease
Time Frame: 6 months
a short questionnaire will be filled out at the time of serologic testing. If a patient hads celiac disease the form will be filled out again at 6 months after diagnosis.
6 months
medication adjustment
Time Frame: 6 months
Patients diagnosed with celiac disease who initiate a gluten free diet will be assessed to determine whether adjustment of levothyroxine dosing is necessary
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Vermont

Investigators

  • Principal Investigator: Richard Zubarik, MD, University of Vermont

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

May 20, 2013

First Submitted That Met QC Criteria

May 21, 2013

First Posted (Estimate)

May 24, 2013

Study Record Updates

Last Update Posted (Estimate)

December 8, 2014

Last Update Submitted That Met QC Criteria

December 5, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZUBM12133

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe