Detection of Celiac Disease in Patients With Hypothyroidism

Celiac Disease Clinical Trial

Official title:

Detection of Celiac Disease in Patients With Hypothyroidism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01862510
• Other study ID #: ZUBM12133
• Status: Completed
• Phase: N/A
• First received: May 20, 2013
• Last updated: December 5, 2014
• Start date: March 2012
• Est. completion date: December 2014

Study information

• Verified date: December 2014
• Source: University of Vermont
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Celiac Disease
• Celiac Sprue
• Hypothyroidism
• Malabsorption
• Malabsorption Syndromes

Locations

Country	Name	City	State
United States	Fletcher Allen Health Care	Burlington	Vermont

Sponsors (1)

Lead Sponsor	Collaborator
University of Vermont

Country where clinical trial is conducted

United States, 

References & Publications (1)

Collins D, Wilcox R, Nathan M, Zubarik R. Celiac disease and hypothyroidism. Am J Med. 2012 Mar;125(3):278-82. doi: 10.1016/j.amjmed.2011.09.003. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	presence of celiac disease		1 month	No
Secondary	Symptoms associated with celiac disease	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	No
Secondary	medication adjustment	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	No