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Trial to Evaluate the Efficacy of a Zinc, Selenium, and L-Tyrosine Supplement in the Prevention of Thyrotoxicosis in Subjects With r25191G/A SEPP1 Polymorphism
Sponsor: S.LAB (SOLOWAYS)
Summary
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.
Official title: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy of a Zinc, Selenium, and L-Tyrosine Supplement in the Prevention of Thyrotoxicosis in Subjects With r25191G/A SEPP1 Polymorphism
Key Details
Gender
All
Age Range
18 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
150
Start Date
2025-07-30
Completion Date
2025-12-30
Last Updated
2025-06-08
Healthy Volunteers
No
Conditions
Interventions
zinc, selenium, and L-tyrosine in SEPP1
zinc, selenium, and L-tyrosine in SEPP1 polymorphism
Placebo
placebo comparator in SEPP1 polymorphism group
Locations (1)
Center of New Medical Technologies
Novosibirsk, Novosibisk Region, Russia