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Detection of Celiac Disease in Patients With Hypothyroidism

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ClinicalTrials.gov Identifier: NCT01862510
Recruitment Status : Completed
First Posted : May 24, 2013
Last Update Posted : December 8, 2014
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease
Celiac Disease Hypothyroidism Celiac Sprue Malabsorption

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 Design

Study Type : Observational
Actual Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Detection of Celiac Disease in Patients With Hypothyroidism
Study Start Date : March 2012
Primary Completion Date : December 2014
Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :
  1. presence of celiac disease [ Time Frame: 1 month ]

Secondary Outcome Measures :
  1. 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.

  2. 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

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients with hypothyroidism who take thyroid replacement therapy

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01862510

United States, Vermont
Fletcher Allen Health Care
Burlington, Vermont, United States, 05405
Sponsors and Collaborators
University of Vermont
Principal Investigator: Richard Zubarik, MD University of Vermont
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Richard Zubarik, MD, University of Vermont
ClinicalTrials.gov Identifier: NCT01862510     History of Changes
Other Study ID Numbers: ZUBM12133
First Posted: May 24, 2013    Key Record Dates
Last Update Posted: December 8, 2014
Last Verified: December 2014

Keywords provided by Richard Zubarik, University of Vermont:
Celiac Disease
Celiac Sprue

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