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 (ZEST-PREP)

June 6, 2025 updated by: S.LAB (SOLOWAYS)

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Russian Federation
    • Novosibisk Region
      • Novosibirsk, Novosibisk Region, Russian Federation, 630090
        • Center of New Medical Technologies

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: placebo group
Other: Placebo
placebo comparator in SEPP1 polymorphism group
Experimental: zinc, selenium, and L-tyrosine supplementation
Dietary supplement: zinc, selenium, and L-tyrosine in SEPP1
zinc, selenium, and L-tyrosine in SEPP1 polymorphism

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percent change of Thyroid Peroxidase Antibodies (TPOAb) in subjects with r25191 SEPP1 polymorphism
Time Frame: 6 months
6 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

S.LAB (SOLOWAYS)

Collaborators

Center of New Medical Technologies

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 30, 2025

Primary Completion (Estimated)

October 15, 2025

Study Completion (Estimated)

December 30, 2025

Study Registration Dates

First Submitted

February 9, 2024

First Submitted That Met QC Criteria

February 9, 2024

First Posted (Actual)

February 20, 2024

Study Record Updates

Last Update Posted (Actual)

June 8, 2025

Last Update Submitted That Met QC Criteria

June 6, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SW006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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