Selenium Treatment in Autoimmune Thyroiditis (AIT)

Selenium Treatment in Autoimmune Thyroiditis: Long Term Follow-Up With Variable Doses

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00271427

Enrollment

100

Registered

2006-01-02

Start date

2004-12-31

Completion date

2005-08-31

Last updated

2006-08-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autoimmune Thyroiditis, Hashimotos Thyroiditis

Keywords

Thyroiditis, Autoimmune, Hashimoto's, TPOAb, Selenium

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.

Interventions

DRUGL-Selenomethionine

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

FEMALE

Age

15 Years to 70 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
statistically important change in serum TPOAb titers.	—

Secondary

Measure	Time frame
Observe the long term effects to 9th mo.	—

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026