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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
60
Reduction of anti-thyroid antibodies
Anti thyroperoxidase and thyroglobulin antibodies are measured by a chemiluminescent assay. Any statistically significant decrease of one or both antibody values compared to the baseline is considered a reduction relevant to the study outcome.
Time frame: 12 months
Improvement of thyroid echogenicity
High-resolution sonograhic images are captured, converted into a spectrum of gray-scale pixels (gsp) ranging from 0 (lowest echogenicity) to 255 (highest echogenicity) and a mean value is then obtained. Any statistically significant increase of the gsp compared to the baseline is considered an improvement relevant to the study outcome.
Time frame: 12 months
Prevention or reduction of the incidence of hypothyroidism
Defined by a significant lower number of new subclinical or overt hypothyroidism cases in the two Semet groups compared to the placebo group.
Time frame: 24 months
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