Detection of Celiac Disease in Patients With Hypothyroidism

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-03-31

Study Completion Date

2014-12-31

Brief Summary

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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

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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.

Conditions

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Celiac Disease Hypothyroidism Celiac Sprue Malabsorption

Keywords

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Celiac Disease Hypothyroidism Celiac Sprue Malabsorption

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Richard Zubarik

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Richard Zubarik, MD

Role: PRINCIPAL_INVESTIGATOR

University of Vermont

Locations

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Fletcher Allen Health Care

Burlington, Vermont, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND

PMID: 22340926 (View on PubMed)

Zubarik R, Ganguly E, Nathan M, Vecchio J. Celiac disease detection in hypothyroid patients requiring elevated thyroid supplementation: A prospective cohort study. Eur J Intern Med. 2015 Dec;26(10):825-9. doi: 10.1016/j.ejim.2015.09.011. Epub 2015 Sep 28.

Reference Type DERIVED

PMID: 26423749 (View on PubMed)

Other Identifiers

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ZUBM12133

Identifier Type: -

Identifier Source: org_study_id