NCT06264544

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

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: S.LAB (SOLOWAYS) · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Thyrotoxicosis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-07-30
• Primary completion: 2025-10-15
• Completion: 2025-12-30
• First posted: 2024-02-20
• Last updated: 2025-06-08

Locations

1 site across 1 country: Russia