Selenium Treatment in Autoimmune Thyroiditis (AIT)
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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 |
Eligibility| Ages Eligible for Study: | 15 Years to 70 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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| Turkey | |
| Dep. of Nuc. Med., Ege University Faculty of Medicine. | |
| Izmir, Turkey, 35100 | |
| 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 Hashimoto Disease Thyroiditis, Autoimmune Thyroid Diseases Endocrine System Diseases Autoimmune Diseases Immune System Diseases Selenium |
Trace Elements Micronutrients Growth Substances Physiological Effects of Drugs Pharmacologic Actions Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents |
ClinicalTrials.gov processed this record on May 16, 2013