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Detection of Celiac Disease in Patients With Hypothyroidism

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Richard Zubarik, University of Vermont
ClinicalTrials.gov Identifier:
NCT01862510
First received: May 20, 2013
Last updated: December 5, 2014
Last verified: December 2014
  Purpose

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.


Condition
Celiac Disease
Hypothyroidism
Celiac Sprue
Malabsorption

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Detection of Celiac Disease in Patients With Hypothyroidism

Resource links provided by NLM:


Further study details as provided by University of Vermont:

Primary Outcome Measures:
  • presence of celiac disease [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Symptoms associated with celiac disease [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Patients diagnosed with celiac disease who initiate a gluten free diet will be assessed to determine whether adjustment of levothyroxine dosing is necessary


Enrollment: 500
Study Start Date: March 2012
Study Completion Date: December 2014
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Patients with hypothyroidism who take thyroid replacement therapy

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01862510

Locations
United States, Vermont
Fletcher Allen Health Care
Burlington, Vermont, United States, 05405
Sponsors and Collaborators
University of Vermont
Investigators
Principal Investigator: Richard Zubarik, MD University of Vermont
  More Information

Publications:
Responsible Party: Richard Zubarik, MD, University of Vermont
ClinicalTrials.gov Identifier: NCT01862510     History of Changes
Other Study ID Numbers: ZUBM12133
Study First Received: May 20, 2013
Last Updated: December 5, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Vermont:
Celiac Disease
Hypothyroidism
Celiac Sprue
Malabsorption

Additional relevant MeSH terms:
Celiac Disease
Hypothyroidism
Digestive System Diseases
Endocrine System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Malabsorption Syndromes
Metabolic Diseases
Thyroid Diseases

ClinicalTrials.gov processed this record on March 26, 2015