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
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.
Investigators
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)