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
Key facts
- Who runs it
- S.LAB (SOLOWAYS)
- Where
- Novosibirsk, RussiaSee the site
- Trial code
- Status
- Not yet recruiting
- People taking part
- 150 people, planned
- Started
- 30 Jul 2025
- Planned end
- 30 Dec 2025
- Type of study
- Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- zinc, selenium, and L-tyrosine in SEPP1
- Placebo
- Record updated
- 8 June 2025
Who can take part
- Age
- 18 years to 85 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 5 criteriaShow less
Who can take part
- Confirmed presence of one or more specified gene polymorphism r25191G/A SEPP1
- TPOAb levels > 300 IU/mL
Who cannot take part
- Subjects with allergy to any of the supplementation component patients with any established diagnosis of thyroid disease
- Age < 18 years and >85
- Pregnant or breastfeeding woman
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 85 years old?
Where in Russia
- Center of New Medical TechnologiesNovosibirsk, RussiaContact: Andrey V Ponomarenko, MDNo longer taking part
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- zinc, selenium, and L-tyrosine supplementationTreatment being tested
Treatment: zinc, selenium, and L-tyrosine in SEPP1
- placebo groupPlacebo, for comparison
Treatment: Placebo
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- 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
- Fit questions
- Built from NCT06264544, who can take part
- Record updated
- 8 June 2025