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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

Study acronym: ZEST-PREP
StatusNot Yet Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
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.

Record History

  1. Notable Start date: Mar 30, 2025 to Jul 30, 2025v3
  2. Notable Primary completion date: Oct 15, 2024 to Oct 15, 2025
    • Start date: Mar 30, 2024 to Mar 30, 2025
    • Study completion date: Dec 30, 2024 to Dec 30, 2025
    v2
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06264544
Lead Sponsor S.LAB (SOLOWAYS)
Collaborators: Center of New Medical Technologies
Conditions
(from sponsor)
Thyrotoxicosis
Related terms Thyrotoxicosis
Enrollment 150 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov