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Selenium Treatment in Autoimmune Thyroiditis (AIT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00271427
Recruitment Status : Completed
First Posted : January 2, 2006
Last Update Posted : August 23, 2006
Information provided by:
Ege University

Brief Summary:
Selenium suppresses autoimmune destruction of thyrocytes and decreases titers of serum TPOAb in AIT patients. Older 4 clinical trials approved the efficacy of the daily dose of 200micg. It's believed that Se saturates the deficient stores of GPX so GPX saves the thyrocytes against to oxidative stresses. Although less than 70 micg/d is sufficient to maximize GPX activity, none of the authors tested the doses less than 200 micg/d. Our hypothesis was that If 100 micg/d can not suppress the TPOAb titers,it means autoimmune destruction can not be blocked by saturation of deficient stores of GPX solely and the mechanism of action requires more than repletion of deficient stores. It's important not only to estimate the optimal dose but to understand the mechanism of action. High dose therapy may also suppress TPOAb levels in Se-non-deficient AIT patients, if it is so, Se therapy may becomes the solely treatment modality which can suppress the autoimmunity in more than 400 million AIT patients. Because there've been no way to suppress autoimmune war and replacement of LT4 had been the only treatment modality for palliation. An other independent part of the study is to test the effect of Se in adolescent AIT patients.

Condition or disease Intervention/treatment Phase
Autoimmune Thyroiditis Hashimotos Thyroiditis Drug: L-Selenomethionine Not Applicable

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Study Type : Interventional  (Clinical Trial)
Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Selenium Treatment in Autoimmune Thyroiditis: Long Term Follow-Up With Variable Doses
Study Start Date : December 2004
Study Completion Date : August 2005

Primary Outcome Measures :
  1. statistically important change in serum TPOAb titers.

Secondary Outcome Measures :
  1. Observe the long term effects to 9th mo.

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Clinically approved AIT patients who do not use any medication other than LT4 to keep TSH in the lower half of normal range.

Exclusion Criteria:

  • Any kind of drug use other than LT4 or any kind of known pathology which may effect GIS absorption.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00271427

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Dep. of Nuc. Med., Ege University Faculty of Medicine.
Izmir, Turkey, 35100
Sponsors and Collaborators
Ege University
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Principal Investigator: Omer Turker, Specialist Dep. of Nuc. Med., Gulhane Military Academy of Medicine
Study Director: Kamil Kumanlioglu, Prof. Dep. of Nuc. Med., Ege University Faculty of Medicine.
Layout table for additonal information Identifier: NCT00271427    
Other Study ID Numbers: STAIT
First Posted: January 2, 2006    Key Record Dates
Last Update Posted: August 23, 2006
Last Verified: December 2004
Keywords provided by Ege University:
Additional relevant MeSH terms:
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Hashimoto Disease
Thyroiditis, Autoimmune
Thyroid Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Trace Elements
Growth Substances