Selenium Treatment in Autoimmune Thyroiditis (AIT)

NCT00271427 | Completed

• 1 other identifier: STAIT
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Autoimmune Thyroiditis; Hashimotos Thyroiditis

Keywords

Thyroiditis; Autoimmune; Hashimoto's; TPOAb; Selenium

Outcome Measures

Primary Outcomes (1)

• statistically important change in serum TPOAb titers.

Secondary Outcomes (1)

• Observe the long term effects to 9th mo.

Interventions

L-Selenomethionine DRUG

Eligibility Criteria

• Age: 15 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinically approved AIT patients who do not use any medication other than LT4 to keep TSH in the lower half of normal range.

You may not qualify if:

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

Sponsors & Collaborators

• Ege University: lead

Study Sites (1)

Dep. of Nuc. Med., Ege University Faculty of Medicine.

Izmir, 35100, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 16837619 BACKGROUND

MeSH Terms

Conditions

Thyroiditis, Autoimmune; Thyroiditis

Interventions

Selenium

Condition Hierarchy (Ancestors)

Thyroid Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Chalcogens; Elements; Inorganic Chemicals; Minerals

Study Officials

• Omer Turker, Specialist

  Dep. of Nuc. Med., Gulhane Military Academy of Medicine

  PRINCIPAL INVESTIGATOR

• Kamil Kumanlioglu, Prof.

  Dep. of Nuc. Med., Ege University Faculty of Medicine.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 30, 2005
• First Posted: January 2, 2006
• Study Start: December 1, 2004
• Study Completion: August 1, 2005
• Last Updated: August 23, 2006

Record last verified: 2004-12

Locations

TU (1)