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

NCT ID: NCT06264544

Last Updated: 2025-06-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-30

Study Completion Date

2025-12-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Thyrotoxicosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

zinc, selenium, and L-tyrosine supplementation

Group Type EXPERIMENTAL

zinc, selenium, and L-tyrosine in SEPP1

Intervention Type DIETARY_SUPPLEMENT

zinc, selenium, and L-tyrosine in SEPP1 polymorphism

placebo group

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

placebo comparator in SEPP1 polymorphism group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

zinc, selenium, and L-tyrosine in SEPP1

zinc, selenium, and L-tyrosine in SEPP1 polymorphism

Intervention Type DIETARY_SUPPLEMENT

Placebo

placebo comparator in SEPP1 polymorphism group

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Center of New Medical Technologies

OTHER

Sponsor Role collaborator

S.LAB (SOLOWAYS)

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Center of New Medical Technologies

Novosibirsk, Novosibisk Region, Russia

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Russia

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Andrey V Ponomarenko, MD

Role: CONTACT

9628316017 ext. +7

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SW006

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Iodine Supplementation in Graves' Hyperthyroidism
NCT06540469 NOT_YET_RECRUITING NA