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
Sponsors and collaborators
S.LAB (SOLOWAYS)
Lead sponsor
Center of New Medical Technologies
Collaborator