Detection of Celiac Disease in Patients With Hypothyroidism

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.

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Key information

Conditions

Celiac Disease Celiac Sprue Digestive System Diseases Endocrine System Diseases Gastrointestinal Diseases Hypothyroidism Intestinal Diseases Malabsorption Malabsorption Syndromes Metabolic Diseases Nutritional and Metabolic Diseases Thyroid Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fletcher Allen Health Care

Burlington, Vermont, 05405, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

presence of celiac disease

Time frame: 1 month

Secondary outcomes

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.
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

Sponsors and collaborators

Lead sponsor

University of Vermont

Other

Registry information

Important dates

Study start: 2012
Primary completion: 2014
Study completion: 2014
First posted: May 24, 2013
Registry last updated: Dec 8, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed