Selenium Treatment in Autoimmune Thyroiditis (AIT)
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| First Received Date ICMJE | December 30, 2005 | ||||||||
| Last Updated Date | August 22, 2006 | ||||||||
| Start Date ICMJE | December 2004 | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Current Primary Outcome Measures ICMJE |
statistically important change in serum TPOAb titers. | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00271427 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Observe the long term effects to 9th mo. | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Selenium Treatment in Autoimmune Thyroiditis (AIT) | ||||||||
| Official Title ICMJE | Selenium Treatment in Autoimmune Thyroiditis: Long Term Follow-Up With Variable Doses | ||||||||
| 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. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double-Blind Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE | Drug: L-Selenomethionine | ||||||||
| Study Arm (s) | Not Provided | ||||||||
| Publications * | 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. | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | 100 | ||||||||
| Completion Date | August 2005 | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||||||
| Ages | 15 Years to 70 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | Turkey | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00271427 | ||||||||
| Other Study ID Numbers ICMJE | STAIT | ||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||
| Responsible Party | Not Provided | ||||||||
| Study Sponsor ICMJE | Ege University | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Ege University | ||||||||
| Verification Date | December 2004 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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