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Clinical Trials/NCT06264544
NCT06264544
Not yet recruiting
Not Applicable

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

S.LAB (SOLOWAYS)1 site in 1 country150 target enrollmentJuly 30, 2025
ConditionsThyrotoxicosis

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Thyrotoxicosis
Sponsor
S.LAB (SOLOWAYS)
Enrollment
150
Locations
1
Primary Endpoint
Percent change of Thyroid Peroxidase Antibodies (TPOAb) in subjects with r25191 SEPP1 polymorphism
Status
Not yet recruiting
Last Updated
10 months ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
July 30, 2025
End Date
December 30, 2025
Last Updated
10 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
S.LAB (SOLOWAYS)
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Confirmed presence of one or more specified gene polymorphism r25191G/A SEPP1
  • TPOAb levels \> 300 IU/mL

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Percent change of Thyroid Peroxidase Antibodies (TPOAb) in subjects with r25191 SEPP1 polymorphism

Time Frame: 6 months

Secondary Outcomes

  • Free Triiodothyronine (Free T3) change in subjects with r25191 SEPP1 polymorphism(6 months)
  • TSH Receptor Antibodies (TSHR-Ab) change in subjects with r25191 SEPP1 polymorphism(6 months)
  • Percent change in Thyroglobulin Antibodies (TgAb) in subjects with r25191 SEPP1 polymorphism(6 months)
  • Free Thyroxine (Free T4) change in subjects with r25191 SEPP1 polymorphism(6 months)
  • Thyroid Receptor Antibodies (TRAb) change in subjects with r25191 SEPP1 polymorphism(6 months)

Study Sites (1)

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