Trial record 1 of 98 for:    "Celiac Disease"
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Detection of Celiac Disease in Patients With Hypothyroidism

This study is currently recruiting participants.
Verified May 2013 by University of Vermont
Sponsor:
Information provided by (Responsible Party):
Richard Zubarik, University of Vermont
ClinicalTrials.gov Identifier:
NCT01862510
First received: May 20, 2013
Last updated: May 21, 2013
Last verified: May 2013
  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


Estimated Enrollment: 500
Study Start Date: March 2012
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
  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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01862510

Contacts
Contact: RIchard Zubarik, MD 802-847-8865 Richard.Zubarik@vtmednet.org

Locations
United States, Vermont
Fletcher Allen Health Care Recruiting
Burlington, Vermont, United States, 05405
Contact: Richard Zubarik, MD    802-847-8865    richard.zubarik@vtmednet.org   
Principal Investigator: Richard Zubarik, MD         
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: May 21, 2013
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
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases
Thyroid Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 21, 2014