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Winthrop University Hospital

Treatment for Chronic Idiopathic Urticaria in Patients with Autoimmune Thyroid Disease

Summary

Subjects with ÒhivesÓ not responsive to standard treaments and who have blood tests diagnosing autoimmune thyroid disease will be tested to see if thyroid hormone is a beneficialo treament. The study will be carried out by physicians of the WUH Divison of Allergy.. This evaluation will involve blood tests, skin tests and physical examinations. Subjects will be given daily medications containing either thyroid hormone at safe doses for 8 weeks and placebo for 8 weeks. Subjects will monitor their symptoms and be evaluated every 4 weeks.

Description

The study will last 4 months. You will take a daily tablet which will contain either thyroid hormone at a dose calculated for your body weight or an inactive placebo for two consecutive 8 week periods. A placebo is an inactive drug. After the first eight weeks you will be switched from active thyroid hormone to placebo or from placebo to active thyroid hormone, depending on which one you started with. You will not know which one you will be taking at any time. You will be asked to monitor your symptoms and you will be evaluated by an allergist every four weeks. Disease activity will be monitored according to published symptom scores for urticaria. You will record daily symptoms, including pruritus (itchiness), and number of the wheals (hives), disturbance of sleep and daily activity throughout the study. Blood tests will be taken before the first pill is taken and at each 4-week interval until the end of the 16-week study. These blood tests will be used to assess the dosage of thyroid hormone you are on and whether it is safe to increase (or decrease) the dosage as clinically indicated at each 4-week interval

Inclusion/exclusion

Subjects 18-50 yrs old in good health, without heart disease, and without prescribed thyriod medications who have been diagnosed with idiopathic urticaria and have blood tests diagnosing autoimmune thyroid disease.

Principal Investigator

Lawrence Shapiro, MD

Department

Department of Medicine

Email

Lshapiro@winthrop.org

Other Contact

Dr. Luz Fonacier LFonacier@winthrop.org
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