Selenium Treatment in Autoimmune Thyroiditis (AIT)

This study has been completed.
Sponsor:
Information provided by:
Ege University
ClinicalTrials.gov Identifier:
NCT00271427
First received: December 30, 2005
Last updated: August 22, 2006
Last verified: December 2004
  Purpose

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 Intervention
Autoimmune Thyroiditis
Hashimotos Thyroiditis
Drug: L-Selenomethionine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Selenium Treatment in Autoimmune Thyroiditis: Long Term Follow-Up With Variable Doses

Resource links provided by NLM:


Further study details as provided by Ege University:

Primary Outcome Measures:
  • statistically important change in serum TPOAb titers.

Secondary Outcome Measures:
  • Observe the long term effects to 9th mo.

Estimated Enrollment: 100
Study Start Date: December 2004
Estimated Study Completion Date: August 2005
  Eligibility

Ages Eligible for Study:   15 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00271427

Locations
Turkey
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.
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00271427     History of Changes
Other Study ID Numbers: STAIT
Study First Received: December 30, 2005
Last Updated: August 22, 2006
Health Authority: Turkey: Ministry of Health

Keywords provided by Ege University:
Thyroiditis
Autoimmune
Hashimoto's
TPOAb
Selenium

Additional relevant MeSH terms:
Thyroiditis, Autoimmune
Autoimmune Diseases
Hashimoto Disease
Thyroiditis
Endocrine System Diseases
Immune System Diseases
Thyroid Diseases
Selenium
Antioxidants
Growth Substances
Micronutrients
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Trace Elements

ClinicalTrials.gov processed this record on October 22, 2014