UnknownPhase 2

Effect of Semet (80 and 160 mcg) Versus Placebo in Euthyroid Patients With AIT

60 participantsStarted 2012-12

Plain-language summary

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.

Who can participate

Age range18 Years – 65 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Reduction of anti-thyroid antibodies

Timeframe: 12 months

Improvement of thyroid echogenicity

Timeframe: 12 months

Trial details

NCT IDNCT02302768

SponsorUniversity of Siena

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-01

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