ThyrotoxicosisZEST-PREPNCT06264544
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
A study testing zinc, selenium, and L-tyrosine in SEPP1 in people with Thyrotoxicosis, run by S.LAB (SOLOWAYS) at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Thyrotoxicosis
- What is being tested?
- zinc, selenium, and L-tyrosine in SEPP1
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteRussia
- Study dates
- 30 Jul 2025to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed presence of one or more specified gene polymorphism r25191G/A SEPP1
- TPOAb levels > 300 IU/mL
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Russia1 site
Center of New Medical Technologies
Novosibirsk, Novosibisk Region, 630090
About this study
Official 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
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
- Being tested
- zinc, selenium, and L-tyrosine in SEPP1, Placebo
- Keywords
- Thyrotoxicosis Prevention, SEPP1 Polymorphism, Zinc, Selenium, and L-Tyrosine Supplementation, supplementation, Nutrigenomics, Thyroid Peroxidase Antibodies (TPOAb)
- Medical subject headings
- Thyrotoxicosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
zinc, selenium, and L-tyrosine in SEPP1Dietary supplement
zinc, selenium, and L-tyrosine in SEPP1 polymorphism
PlaceboOther
placebo comparator in SEPP1 polymorphism group
| Study group | Role | What they receive |
|---|---|---|
| zinc, selenium, and L-tyrosine supplementation | Experimental | Not described Receives: Dietary Supplement: zinc, selenium, and L-tyrosine in SEPP1 |
| placebo group | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change of Thyroid Peroxidase Antibodies (TPOAb) in subjects with r25191 SEPP1 polymorphism
Measured: 6 months
Secondary outcomes (5)
Percent change in Thyroglobulin Antibodies (TgAb) in subjects with r25191 SEPP1 polymorphism
Measured: 6 months
Free Thyroxine (Free T4) change in subjects with r25191 SEPP1 polymorphism
Measured: 6 months
Free Triiodothyronine (Free T3) change in subjects with r25191 SEPP1 polymorphism
Measured: 6 months
Thyroid Receptor Antibodies (TRAb) change in subjects with r25191 SEPP1 polymorphism
Measured: 6 months
TSH Receptor Antibodies (TSHR-Ab) change in subjects with r25191 SEPP1 polymorphism
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start30 Jul 2025 (estimated)
- Primary completion15 Oct 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThyrotoxicosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- S.LAB (SOLOWAYS)
- Sponsor type
- University, hospital or other
- Collaborators
- Center of New Medical Technologies
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06264544
- Sponsor's protocol ID
- SW006
- Acronym
- ZEST-PREP
- Status last verified
- Jun 2025
- First submitted
- 9 Feb 2024
- Last updated
- 8 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06264544
- Acronym / sponsor ID
- ZEST-PREP / SW006
- Conditions
- Thyrotoxicosis
- Keywords
- Thyrotoxicosis Prevention, SEPP1 Polymorphism, Zinc, Selenium, and L-Tyrosine Supplementation, supplementation, Nutrigenomics, Thyroid Peroxidase Antibodies (TPOAb)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- S.LAB (SOLOWAYS)University, hospital or other
- Collaborators
- Center of New Medical Technologies
- Study start
- 30 Jul 2025 (estimated)
- Primary completion
- 15 Oct 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 20 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| zinc, selenium, and L-tyrosine supplementation | Experimental | Dietary Supplement: zinc, selenium, and L-tyrosine in SEPP1 |
| placebo group | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Confirmed presence of one or more specified gene polymorphism r25191G/A SEPP1
- TPOAb levels > 300 IU/mL
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| zinc, selenium, and L-tyrosine in SEPP1zinc, selenium, and L-tyrosine in SEPP1 polymorphism | Dietary supplement | zinc, selenium, and L-tyrosine supplementation |
| Placeboplacebo comparator in SEPP1 polymorphism group | Other | placebo group |
Primary outcome
Percent change of Thyroid Peroxidase Antibodies (TPOAb) in subjects with r25191 SEPP1 polymorphism
Time frame: 6 months
5 secondary outcomes
Percent change in Thyroglobulin Antibodies (TgAb) in subjects with r25191 SEPP1 polymorphism
Time frame: 6 months
Free Thyroxine (Free T4) change in subjects with r25191 SEPP1 polymorphism
Time frame: 6 months
Free Triiodothyronine (Free T3) change in subjects with r25191 SEPP1 polymorphism
Time frame: 6 months
Thyroid Receptor Antibodies (TRAb) change in subjects with r25191 SEPP1 polymorphism
Time frame: 6 months
TSH Receptor Antibodies (TSHR-Ab) change in subjects with r25191 SEPP1 polymorphism
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing zinc, selenium, and L-tyrosine in SEPP1 in people with Thyrotoxicosis, run by S.LAB (SOLOWAYS) at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrey V Ponomarenko, MD (9628316017 ext. +7, dasyshadoff@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent change of Thyroid Peroxidase Antibodies (TPOAb) in subjects with r25191 SEPP1 polymorphism (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2025.