This randomized, double-blind, placebo-controlled trial evaluates the efficacy of a zinc, selenium, and L-tyrosine supplement in preventing thyrotoxicosis among adults aged 18-85 with elevated TPOAb levels and the r25191G/A SEPP1 polymorphism. The study excludes those with thyroid disease, pregnant/breastfeeding women, and individuals allergic to the supplement. Key endpoints include changes in thyroid antibodies and hormones over a 6-month period. With an estimated sample size of 150 participants per group, accounting for a 20% dropout rate, the trial seeks to demonstrate the supplement's potential in reducing thyrotoxicosis risk through a genetically-informed approach.
Confirmed presence of one or more specified gene polymorphism r25191G/A SEPP1
TPOAb levels > 300 IU/mL
Age < 18 years and >85
Pregnant or breastfeeding woman
Subjects with allergy to any of the supplementation component patients with any established diagnosis of thyroid disease
Parallel
zinc, selenium, and L-tyrosine in SEPP1
Dietary supplementzinc, selenium, and L-tyrosine in SEPP1 polymorphism
Placebo
Other interventionplacebo comparator in SEPP1 polymorphism group
Percent change of Thyroid Peroxidase Antibodies (TPOAb) in subjects with r25191 SEPP1 polymorphism
Percent change in Thyroglobulin Antibodies (TgAb) in subjects with r25191 SEPP1 polymorphism
Free Thyroxine (Free T4) change in subjects with r25191 SEPP1 polymorphism
Free Triiodothyronine (Free T3) change in subjects with r25191 SEPP1 polymorphism
Thyroid Receptor Antibodies (TRAb) change in subjects with r25191 SEPP1 polymorphism
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S.LAB (SOLOWAYS)
Lead sponsor
Center of New Medical Technologies
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
