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This study evaluated a supplement containing selenomethionine and myo-inositol in patients with autoimmune thyroiditis who carry the DIO2 Thr92Ala polymorphism. Adults aged 18-65 with autoimmune thyroiditis who agreed to be genotyped for the DIO2 Thr92Ala variant took part. Sponsored by S.LAB (SOLOWAYS), this study without an assigned phase has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
Inclusion Criteria: * Adults aged 18-65 years with a clinical diagnosis of autoimmune thyroiditis (elevated anti- TPO and/or anti-Tg). * TSH range consistent with subclinical hypothyroidism (e.g., TSH 4.5-10 mIU/L) or euthyroid status with AIT; patients on stable levothyroxine therapy are eligible if dose was unchanged for at least 6 weeks. * Willingness to undergo genotyping for the DIO2 Thr92Ala variant. Confirmation of the Thr92Ala variant (homozygous or heterozygous) for Cohort A; absence of this variant for Cohort B. * Ability to provide informed consent and comply with study procedures. Exclusion Criteria: * Overt hypothyroidism with TSH \>10 mIU/L requiring immediate treatment adjustment. * Significant comorbidities (e.g., uncompensated heart failure, severe renal or hepatic dysfunction, uncontrolled diabetes). * Pregnancy or lactation (given potential changes in thyroid requirements and supplement safety considerations). * Known hypersensitivity to selenium or inositol supplements. * Severe psychiatric disorder interfering with protocol adherence. * Concurrent use of high-dose selenium (\>50 µg/day) or other thyroid-influencing nutraceuticals that cannot be discontinued prior to study entry.