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Selenium Treatment in Autoimmune Thyroiditis (AIT)

Primary Purpose

Autoimmune Thyroiditis, Hashimotos Thyroiditis

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
L-Selenomethionine
Sponsored by
Ege University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autoimmune Thyroiditis focused on measuring Thyroiditis, Autoimmune, Hashimoto's, TPOAb, Selenium

Eligibility Criteria

15 Years - 70 Years (Child, Adult, Older Adult)FemaleDoes not accept 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.

Sites / Locations

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

Outcomes

Primary Outcome Measures

statistically important change in serum TPOAb titers.

Secondary Outcome Measures

Observe the long term effects to 9th mo.

Full Information

First Posted
December 30, 2005
Last Updated
August 22, 2006
Sponsor
Ege University
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1. Study Identification

Unique Protocol Identification Number
NCT00271427
Brief Title
Selenium Treatment in Autoimmune Thyroiditis (AIT)
Official Title
Selenium Treatment in Autoimmune Thyroiditis: Long Term Follow-Up With Variable Doses
Study Type
Interventional

2. Study Status

Record Verification Date
December 2004
Overall Recruitment Status
Completed
Study Start Date
December 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Ege University

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autoimmune Thyroiditis, Hashimotos Thyroiditis
Keywords
Thyroiditis, Autoimmune, Hashimoto's, TPOAb, Selenium

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
100 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
L-Selenomethionine
Primary Outcome Measure Information:
Title
statistically important change in serum TPOAb titers.
Secondary Outcome Measure Information:
Title
Observe the long term effects to 9th mo.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Omer Turker, Specialist
Organizational Affiliation
Dep. of Nuc. Med., Gulhane Military Academy of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kamil Kumanlioglu, Prof.
Organizational Affiliation
Dep. of Nuc. Med., Ege University Faculty of Medicine.
Official's Role
Study Director
Facility Information:
Facility Name
Dep. of Nuc. Med., Ege University Faculty of Medicine.
City
Izmir
ZIP/Postal Code
35100
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
16837619
Citation
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.
Results Reference
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Selenium Treatment in Autoimmune Thyroiditis (AIT)

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