Selenium Treatment in Autoimmune Thyroiditis (AIT)

August 22, 2006 updated by: Ege University

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

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.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Izmir, Turkey, 35100
        • Dep. of Nuc. Med., Ege University Faculty of Medicine.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 70 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
statistically important change in serum TPOAb titers.

Secondary Outcome Measures

Outcome Measure
Observe the long term effects to 9th mo.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2004

Study Completion

August 1, 2005

Study Registration Dates

First Submitted

December 30, 2005

First Submitted That Met QC Criteria

December 30, 2005

First Posted (Estimate)

January 2, 2006

Study Record Updates

Last Update Posted (Estimate)

August 23, 2006

Last Update Submitted That Met QC Criteria

August 22, 2006

Last Verified

December 1, 2004

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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