Autoimmune ThyroiditisNCT00271427
Selenium Treatment in Autoimmune Thyroiditis (AIT)
A study testing L-Selenomethionine in people with Autoimmune Thyroiditis and Hashimotos Thyroiditis, run by Ege University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 70 years, women only
- Conditions the study is for
- Autoimmune Thyroiditis, Hashimotos Thyroiditis
- What is being tested?
- L-Selenomethionine
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Dec 2004to Aug 2005
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 70 years
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Clinically approved AIT patients who do not use any medication other than LT4 to keep TSH in the lower half of normal range.
Who cannot join
- Any kind of drug use other than LT4 or any kind of known pathology which may effect GIS absorption.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Dep. of Nuc. Med., Ege University Faculty of Medicine.
Izmir, 35100
About this study
Official title: 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.
- Conditions
- Autoimmune Thyroiditis, Hashimotos Thyroiditis
- Being tested
- L-Selenomethionine
- Keywords
- Thyroiditis, Autoimmune, Hashimoto's, TPOAb, Selenium
- Medical subject headings
- Thyroiditis, Autoimmune, Thyroiditis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-SelenomethionineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
statistically important change in serum TPOAb titers.
Secondary outcomes (1)
Observe the long term effects to 9th mo.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2006 (estimated)
- Study startDec 2004
- Study completionAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Autoimmune ThyroiditisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 100 participants
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Investigators
- Omer Turker, Specialist, Principal investigator, Dep. of Nuc. Med., Gulhane Military Academy of MedicineKamil Kumanlioglu, Prof., Study director, Dep. of Nuc. Med., Ege University Faculty of Medicine.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00271427
- Sponsor's protocol ID
- STAIT
- Status last verified
- Dec 2004
- First submitted
- 30 Dec 2005
- Last updated
- 23 Aug 2006
- Results posted
- No
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. doi: 10.1677/joe.1.06661.
PubMed 16837619
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Selenium Treatment in Autoimmune Thyroiditis: Long Term Follow-Up With Variable Doses
- ClinicalTrials.gov ID
- NCT00271427
- Acronym / sponsor ID
- STAIT
- Conditions
- Autoimmune Thyroiditis, Hashimotos Thyroiditis
- Keywords
- Thyroiditis, Autoimmune, Hashimoto's, TPOAb, Selenium
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- Dec 2004
- Study completion
- Aug 2005
- First posted
- 2 Jan 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 15 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Clinically approved AIT patients who do not use any medication other than LT4 to keep TSH in the lower half of normal range.
Key exclusion criteria (1 listed)
- Any kind of drug use other than LT4 or any kind of known pathology which may effect GIS absorption.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| L-Selenomethionine | Drug | – |
Primary outcome
statistically important change in serum TPOAb titers.
1 secondary outcome
Observe the long term effects to 9th mo.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2006.
- Background: PubMed 16837619Turker 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. doi: 10.1677/joe.1.06661.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Omer Turker, Specialist principal investigator
Dep. of Nuc. Med., Gulhane Military Academy of Medicine
Kamil Kumanlioglu, Prof. study director
Dep. of Nuc. Med., Ege University Faculty of Medicine.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing L-Selenomethionine in people with Autoimmune Thyroiditis and Hashimotos Thyroiditis, run by Ege University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
statistically important change in serum TPOAb titers.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00271427, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2006.