Detection of Celiac Disease in Patients With Hypothyroidism

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01862510

Enrollment

500

Registered

2013-05-24

Start date

2012-03-31

Completion date

2014-12-31

Last updated

2014-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Celiac Disease, Celiac Sprue, Hypothyroidism, Malabsorption

Keywords

Celiac Disease, Hypothyroidism, Celiac Sprue, Malabsorption

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
presence of celiac disease	1 month

Secondary

Measure	Time frame	Description
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

Countries

United States

Outcome results