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CompletedNCT00271427Updated Aug 23, 2006

Selenium Treatment in Autoimmune Thyroiditis (AIT)

An interventional study of L-Selenomethionine in Autoimmune Thyroiditis and Hashimotos Thyroiditis, sponsored by Ege University. Completed at 1 site in Turkey. Open to female participants aged 15 Years to 70 Years. Per ClinicalTrials.gov, last updated 2006-08-23.

Sponsored by Ege University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
15 Years to 70 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Autoimmune Thyroiditis
  • Hashimotos Thyroiditis

Keywords

  • Thyroiditis
  • Autoimmune
  • Hashimoto's
  • TPOAb
  • Selenium
03

In context

Thyroiditis, Autoimmune

27 studies on the registry are indexed under Thyroiditis, Autoimmune; 4 are open to participants now.

This study's enrollment of 100 is above the median of 70 across 19 interventional studies indexed under Thyroiditis, Autoimmune.

Browse Thyroiditis, Autoimmune studies →

Lead sponsor

Ege University is the lead sponsor of 377 studies on the registry; 48 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Years to 70 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Any kind of drug use other than LT4 or any kind of known pathology which may effect GIS absorption.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double
Enrollment
100 participants

Interventions

06

What researchers measure

Primary outcomes

  1. statistically important change in serum TPOAb titers.

Secondary outcomes

  1. Observe the long term effects to 9th mo.

07

Study locations

1 site
  • Dep. of Nuc. Med., Ege University Faculty of Medicine.
    Izmir, 35100, Turkey
08

References and documents

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 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 23, 2006, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00271427
Lead sponsor
Ege University
First posted
Jan 2, 2006
Start date
Dec 2004
Completion
Aug 2005
Last update
Aug 23, 2006

Study contacts

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.
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2004. You cannot join it, but the record below documents what was studied.

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