Selenium Treatment in Autoimmune Thyroiditis (AIT)

Sponsor

Ege University (Other)

Overall Status

Completed

CT.gov ID

NCT00271427

Collaborator

(none)

100

Enrollment

Location

Duration (Months)

12.5

Patients Per Site Per Month

Study Details

Study Description

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	N/A

Study Design

Study Type:

Interventional

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 :

Dec 1, 2004

Study Completion Date :

Aug 1, 2005

Outcome Measures

Primary Outcome Measures

statistically important change in serum TPOAb titers. []

Secondary Outcome Measures

Observe the long term effects to 9th mo. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years to 70 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dep. of Nuc. Med., Ege University Faculty of Medicine.	Izmir		Turkey	35100

Sponsors and Collaborators

Ege University

Investigators

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.