Effect of Semet (80 and 160 mcg) Versus Placebo in Euthyroid Patients With AIT
This trial is active, not recruiting.
|Sponsor||University of Siena|
|Collaborator||IBSA Institut Biochimique SA|
|Start date||December 2012|
|End date||January 2014|
|Trial size||60 participants|
|Trial identifier||NCT02302768, SELENIO 2012|
Over the past 10 years, several clinical studies have suggested that selenium supplementation may influence the natural history of AIT. Recently, Interferon gamma (IFNγ)-inducible chemokines (CXCL-9, -10 and -11) were shown to be elevated in the AIT patients. The aim of this prospective, randomized, controlled study is to evaluate the effect of two different doses of selenomethionine (80 or 160 mcg) versus placebo in euthyroid women with AIT, in terms of reduction of anti-thyroid antibodies and improvement of thyroid hypoechogenicity, over 24 months. Serum levels of selenium, CXCL-9, -10 and -11 and their regulators, Tumor necrosis factor alpha (TNFα) and INFγ, thyroid function and volume and the quality of life of AIT patients are also evaluated.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
|Masking||single blind (subject)|
Reduction of anti-thyroid antibodies
time frame: 12 months
Improvement of thyroid echogenicity
time frame: 12 months
Prevention or reduction of the incidence of hypothyroidism
time frame: 24 months
Female participants from 18 years up to 65 years old.
Inclusion Criteria: - Diagnosis of chronic autoimmune thyroiditis defined by positivity of anti thyroperoxidase and/or anti thyroglobulin antibodies (> or = 100 U/l) and thyroid hypoechogenicity Exclusion Criteria: - Presence of other thyroid disease but micronodules - History of the malignancy in the past 5 years - Drugs affecting immune system and/or thyroid function - Pregnancy detected during screening or follow-up.
|Official title||Effect of Supplementation of Two Doses of L-selenomethionine (Semet; 80 and 160 mcg) Versus Placebo in Patients With Chronic Autoimmune Thyroiditis (AIT) With Normal Thyroid Function.|
|Principal investigator||Furio Pacini, MD|
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