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

Not Applicable

Not yet recruiting

• Conditions: Thyrotoxicosis
• Interventions: Other: Placebo; Dietary Supplement: zinc, selenium, and L-tyrosine in SEPP1

• Registration Number: NCT06264544
• Lead Sponsor: S.LAB (SOLOWAYS)

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-02-09
• Study First Submitted QC: 2024-02-09
• Study First Posted: 2024-02-20
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-14
• Last Update Posted: 2025-03-17
• Study Start: 2025-03-30
• Primary Completion: 2025-10-15
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo group	Placebo	-
zinc, selenium, and L-tyrosine supplementation	zinc, selenium, and L-tyrosine in SEPP1	-

Primary Outcome Measures

Name	Time	Method
Percent change of Thyroid Peroxidase Antibodies (TPOAb) in subjects with r25191 SEPP1 polymorphism	6 months

Secondary Outcome Measures

Name	Time	Method
Free Triiodothyronine (Free T3) change in subjects with r25191 SEPP1 polymorphism	6 months
Percent change in Thyroglobulin Antibodies (TgAb) in subjects with r25191 SEPP1 polymorphism	6 months
TSH Receptor Antibodies (TSHR-Ab) change 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

Trial Locations

Locations (1)

Center of New Medical Technologies; 🇷🇺 Novosibirsk, Novosibisk Region, Russian Federation