Thyrotoxicosis
Conditions
Keywords
Thyrotoxicosis Prevention, SEPP1 Polymorphism, Zinc, Selenium, and L-Tyrosine Supplementation, supplementation, Nutrigenomics, Thyroid Peroxidase Antibodies (TPOAb)
Brief 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. 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
OTHERPlacebo
placebo comparator in SEPP1 polymorphism group
DIETARY_SUPPLEMENTzinc, selenium, and L-tyrosine in SEPP1
zinc, selenium, and L-tyrosine in SEPP1 polymorphism
Sponsors
Center of New Medical Technologies
S.LAB (SOLOWAYS)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent change of Thyroid Peroxidase Antibodies (TPOAb) in subjects with r25191 SEPP1 polymorphism | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| TSH Receptor Antibodies (TSHR-Ab) change in subjects with r25191 SEPP1 polymorphism | 6 months |
| 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 |
| 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 |
Countries
Russia
Contacts
Primary ContactAndrey V Ponomarenko, MD
Outcome results
None listed