- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00271427
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
Conditions
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
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Izmir, Turkey, 35100
- Dep. of Nuc. Med., Ege University Faculty of Medicine.
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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 |
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statistically important change in serum TPOAb titers.
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Secondary Outcome Measures
Outcome Measure |
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Observe the long term effects to 9th mo.
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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
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STAIT
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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