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

NCT06264544 | Not Yet Recruiting

• 1 other identifier: SW006
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Thyrotoxicosis

Keywords

Thyrotoxicosis Prevention; SEPP1 Polymorphism; Zinc, Selenium, and L-Tyrosine Supplementation; supplementation; Nutrigenomics; Thyroid Peroxidase Antibodies (TPOAb)

Outcome Measures

Primary Outcomes (1)

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

  6 months

Secondary Outcomes (5)

• 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

• Free Triiodothyronine (Free T3) change in subjects with r25191 SEPP1 polymorphism

  6 months

• Thyroid Receptor Antibodies (TRAb) change in subjects with r25191 SEPP1 polymorphism

  6 months

• TSH Receptor Antibodies (TSHR-Ab) change in subjects with r25191 SEPP1 polymorphism

  6 months

Study Arms (2)

zinc, selenium, and L-tyrosine supplementation

EXPERIMENTAL

Dietary Supplement: zinc, selenium, and L-tyrosine in SEPP1

placebo group

PLACEBO COMPARATOR

Other: Placebo

Interventions

zinc, selenium, and L-tyrosine in SEPP1 DIETARY_SUPPLEMENT

zinc, selenium, and L-tyrosine in SEPP1 polymorphism

zinc, selenium, and L-tyrosine supplementation

Placebo OTHER

placebo comparator in SEPP1 polymorphism group

placebo group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• S.LAB (SOLOWAYS): lead
• Center of New Medical Technologies: collaborator

Study Sites (1)

Center of New Medical Technologies

Novosibirsk, Novosibisk Region, 630090, Russia

Location

MeSH Terms

Conditions

Thyrotoxicosis

Interventions

Zinc; Selenium; Tyrosine

Condition Hierarchy (Ancestors)

Hyperthyroidism; Thyroid Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals; Chalcogens; Minerals; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Central Study Contacts

Andrey V Ponomarenko, MD

CONTACT

9628316017; dasyshadoff@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2024
• First Posted: February 20, 2024
• Study Start: July 30, 2025
• Primary Completion: October 15, 2025
• Study Completion: December 30, 2025
• Last Updated: June 8, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)