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 (ZEST-PREP)

S.LAB (SOLOWAYS)

Status: Not yet enrolling

Conditions: Thyrotoxicosis

Treatments: Other: Placebo; Dietary Supplement: zinc, selenium, and L-tyrosine in SEPP1

Study type: Interventional

Funder types: Other

Identifiers

NCT06264544

SW006

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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150 participants in 2 patient groups, including a placebo group

zinc, selenium, and L-tyrosine supplementation

Experimental group

Treatment:

Dietary Supplement: zinc, selenium, and L-tyrosine in SEPP1

placebo group

Placebo Comparator group

Treatment:

Other: Placebo