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NCT Number: NCT06264544

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

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center of New Medical Technologies

Novosibirsk, Novosibisk Region, 630090, Russia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

zinc, selenium, and L-tyrosine in SEPP1

Dietary Supplement

zinc, selenium, and L-tyrosine in SEPP1 polymorphism

Placebo

Other

placebo comparator in SEPP1 polymorphism group

Primary outcomes

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

    Time frame: 6 months

Secondary outcomes

  1. Percent change in Thyroglobulin Antibodies (TgAb) in subjects with r25191 SEPP1 polymorphism

    Time frame: 6 months

  2. Free Thyroxine (Free T4) change in subjects with r25191 SEPP1 polymorphism

    Time frame: 6 months

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

    Time frame: 6 months

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

    Time frame: 6 months

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

    Time frame: 6 months

Study contacts

Contact information is provided by the study sponsor or research team.

Andrey V Ponomarenko, MD

CONTACT

[email protected]

9628316017 ext. +7

Sponsors and collaborators

Lead sponsor

S.LAB (SOLOWAYS)

Other

Collaborators

  • Center of New Medical Technologies

Registry information

Official study title

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

Acronym: ZEST-PREP

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 20, 2024
Registry last updated
Jun 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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