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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorS.LAB (SOLOWAYS)

About this trial

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.

Eligibility criteria

Qualifiers

Confirmed presence of one or more specified gene polymorphism r25191G/A SEPP1

TPOAb levels > 300 IU/mL

Disqualifiers

Age < 18 years and >85

Pregnant or breastfeeding woman

Subjects with allergy to any of the supplementation component patients with any established diagnosis of thyroid disease

Trial design

Treatments tested in this trial

  • zinc, selenium, and L-tyrosine in SEPP1
  • Placebo

Treatment groups

150 Participants
are divided into 2 treatment groups

Sponsors and collaborators

S.LAB (SOLOWAYS)

Lead sponsor

Center of New Medical Technologies

Collaborator