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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: zinc, selenium, and L-tyrosine in SEPP1, Placebo.
- Who it may be relevant to
- Registry conditions: Thyrotoxicosis. Basic parameters: 18 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Russia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- Dietary supplement zinc, selenium, and L-tyrosine in SEPP1
zinc, selenium, and L-tyrosine in SEPP1 polymorphism - Other Placebo
placebo comparator in SEPP1 polymorphism group
Primary outcome measures
- Percent change of Thyroid Peroxidase Antibodies (TPOAb) in subjects with r25191 SEPP1 polymorphism [Time frame: 6 months]
Secondary outcome measures (5)
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Prevention
Study locations
Russia · 1 center
- Center of New Medical Technologies — Novosibirsk
Identifiers
NCT: NCT06264544 · SW006