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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
150
zinc, selenium, and L-tyrosine in SEPP1 polymorphism
placebo comparator in SEPP1 polymorphism group
Center of New Medical Technologies
Novosibirsk, Novosibisk Region, Russia
Percent change of Thyroid Peroxidase Antibodies (TPOAb) in subjects with r25191 SEPP1 polymorphism
Time frame: 6 months
Percent change in Thyroglobulin Antibodies (TgAb) in subjects with r25191 SEPP1 polymorphism
Time frame: 6 months
Free Thyroxine (Free T4) change in subjects with r25191 SEPP1 polymorphism
Time frame: 6 months
Free Triiodothyronine (Free T3) change in subjects with r25191 SEPP1 polymorphism
Time frame: 6 months
Thyroid Receptor Antibodies (TRAb) change in subjects with r25191 SEPP1 polymorphism
Time frame: 6 months
TSH Receptor Antibodies (TSHR-Ab) change in subjects with r25191 SEPP1 polymorphism
Time frame: 6 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.