Selenium Treatment in Autoimmune Thyroiditis (AIT)

Autoimmune Thyroiditis Clinical Trial

Official title:

Selenium Treatment in Autoimmune Thyroiditis: Long Term Follow-Up With Variable Doses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00271427
• Other study ID #: STAIT
• Status: Completed
• Phase: N/A
• First received: December 30, 2005
• Last updated: August 22, 2006
• Start date: December 2004
• Est. completion date: August 2005

Study information

• Verified date: December 2004
• Source: Ege University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 2005
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 15 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Autoimmune Thyroiditis
• Hashimoto Disease
• Hashimotos Thyroiditis
• Thyroiditis
• Thyroiditis, Autoimmune

Intervention

Drug:
• L-Selenomethionine

Locations

Country	Name	City	State
Turkey	Dep. of Nuc. Med., Ege University Faculty of Medicine.	Izmir

Sponsors (1)

Lead Sponsor	Collaborator
Ege University

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

Turker O, Kumanlioglu K, Karapolat I, Dogan I. Selenium treatment in autoimmune thyroiditis: 9-month follow-up with variable doses. J Endocrinol. 2006 Jul;190(1):151-6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	statistically important change in serum TPOAb titers.
Secondary	Observe the long term effects to 9th mo.