Detection of Celiac Disease in Patients With Hypothyroidism

Completed

• Conditions: Celiac Disease; Malabsorption; Hypothyroidism; Celiac Sprue

• Registration Number: NCT01862510
• Lead Sponsor: University of Vermont

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.

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 Timeline

• Study Start: 2012-03
• Study First Submitted: 2013-05-20
• Study First Submitted QC: 2013-05-21
• Study First Posted: 2013-05-24
• Status Verified: 2014-12
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Last Update Submitted: 2014-12-05
• Last Update Posted: 2014-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
presence of celiac disease	1 month

Secondary Outcome Measures

Name	Time	Method
Symptoms associated with celiac disease	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.
medication adjustment	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

Trial Locations

Locations (1)

Fletcher Allen Health Care; 🇺🇸 Burlington, Vermont, United States