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NOT YET RECRUITING
NCT06264544
NA

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)

View on ClinicalTrials.gov

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

DIETARY_SUPPLEMENT

zinc, selenium, and L-tyrosine in SEPP1

zinc, selenium, and L-tyrosine in SEPP1 polymorphism

OTHER

Placebo

placebo comparator in SEPP1 polymorphism group

Locations (1)

Center of New Medical Technologies

Novosibirsk, Novosibisk Region, Russia