Clinical Trial

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

Study acronym: ZEST-PREP
Not Yet Recruiting
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Record status
This record was last updated June 8, 2025 (before its estimated October 15, 2025 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2024-02-09; most recent amendment 2025-06-06.
Trial Details
NCT Number NCT06264544
Lead Sponsor S.LAB (SOLOWAYS)
Collaborators: Center of New Medical Technologies
Conditions Thyrotoxicosis
Enrollment 150 participants
Start Date 2025-07-30
Primary Completion 2025-10-15 (estimated)
Study Completion 2025-12-30 (estimated)
Updated on ClinicalTrials.gov 2025-06-08