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Selenium Treatment in Autoimmune Thyroiditis (AIT)

NCT ID: NCT00271427

Last Updated: 2006-08-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-12-31

Study Completion Date

2005-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Autoimmune Thyroiditis Hashimotos Thyroiditis

Keywords

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Thyroiditis Autoimmune Hashimoto's TPOAb Selenium

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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L-Selenomethionine

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

15 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Ege University

OTHER

Sponsor Role lead

Principal Investigators

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Omer Turker, Specialist

Role: PRINCIPAL_INVESTIGATOR

Dep. of Nuc. Med., Gulhane Military Academy of Medicine

Kamil Kumanlioglu, Prof.

Role: STUDY_DIRECTOR

Dep. of Nuc. Med., Ege University Faculty of Medicine.

Locations

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Dep. of Nuc. Med., Ege University Faculty of Medicine.

Izmir, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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. doi: 10.1677/joe.1.06661.

Reference Type BACKGROUND
PMID: 16837619 (View on PubMed)

Other Identifiers

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STAIT

Identifier Type: -

Identifier Source: org_study_id