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| Name | Class |
|---|---|
| Center of New Medical Technologies | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| zinc, selenium, and L-tyrosine supplementation | Experimental |
| |
| placebo group | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| zinc, selenium, and L-tyrosine in SEPP1 | Dietary Supplement | zinc, selenium, and L-tyrosine in SEPP1 polymorphism |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent change of Thyroid Peroxidase Antibodies (TPOAb) in subjects with r25191 SEPP1 polymorphism | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percent change in Thyroglobulin Antibodies (TgAb) in subjects with r25191 SEPP1 polymorphism | 6 months | |
| Free Thyroxine (Free T4) change in subjects with r25191 SEPP1 polymorphism | 6 months | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andrey V Ponomarenko, MD | Contact | 9628316017 | +7 | dasyshadoff@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center of New Medical Technologies | Novosibirsk | Novosibisk Region | 630090 | Russia |
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| Placebo | Other | placebo comparator in SEPP1 polymorphism group |
|
| Free Triiodothyronine (Free T3) change in subjects with r25191 SEPP1 polymorphism |
| 6 months |
| Thyroid Receptor Antibodies (TRAb) change in subjects with r25191 SEPP1 polymorphism | 6 months |
| TSH Receptor Antibodies (TSHR-Ab) change in subjects with r25191 SEPP1 polymorphism | 6 months |
| ID | Term |
|---|---|
| D013971 | Thyrotoxicosis |
| ID | Term |
|---|---|
| D006980 | Hyperthyroidism |
| D013959 | Thyroid Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D015032 | Zinc |
| D012643 | Selenium |
| D014443 | Tyrosine |
| ID | Term |
|---|---|
| D019216 | Metals, Heavy |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D028561 | Transition Elements |
| D008670 | Metals |
| D018011 | Chalcogens |
| D008903 | Minerals |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
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