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

Thyrotoxicosis Clinical Trial

— ZEST-PREP  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06264544
• Other study ID #: SW006
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 30, 2024
• Est. completion date: December 30, 2024

Study information

• Verified date: February 2024
• Source: S.LAB (SOLOWAYS)
• Contact: Andrey V Ponomarenko, MD
• Phone: 9628316017
• Email: dasyshadoff[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: December 30, 2024
• Est. primary completion date: October 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Thyrotoxicosis

Intervention

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

Locations

Country	Name	City	State
Russian Federation	Center of New Medical Technologies	Novosibirsk	Novosibisk Region

Sponsors (2)

Lead Sponsor	Collaborator
S.LAB (SOLOWAYS)	Center of New Medical Technologies

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent change of Thyroid Peroxidase Antibodies (TPOAb) in subjects with r25191 SEPP1 polymorphism		6 months
Secondary	Percent change in Thyroglobulin Antibodies (TgAb) in subjects with r25191 SEPP1 polymorphism		6 months
Secondary	Free Thyroxine (Free T4) change in subjects with r25191 SEPP1 polymorphism		6 months
Secondary	Free Triiodothyronine (Free T3) change in subjects with r25191 SEPP1 polymorphism		6 months
Secondary	Thyroid Receptor Antibodies (TRAb) change in subjects with r25191 SEPP1 polymorphism		6 months
Secondary	TSH Receptor Antibodies (TSHR-Ab) change in subjects with r25191 SEPP1 polymorphism		6 months