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Not yet recruitingNCT06264544ZEST-PREPUpdated Jun 8, 2025

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

An interventional study of zinc, selenium, and L-tyrosine in SEPP1 and Placebo in Thyrotoxicosis, sponsored by S.LAB (SOLOWAYS). Not yet recruiting at 1 site in Russian Federation. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2025-06-08.

Sponsored by S.LAB (SOLOWAYS) · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Primary completion was expected by Oct 2025, 1 year ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
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Study 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.

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Conditions studied

  • Thyrotoxicosis

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Keywords

  • Thyrotoxicosis Prevention
  • SEPP1 Polymorphism
  • Zinc, Selenium, and L-Tyrosine Supplementation
  • supplementation
  • Nutrigenomics
  • Thyroid Peroxidase Antibodies (TPOAb)
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In context

Thyrotoxicosis

21 studies on the registry are indexed under Thyrotoxicosis; 5 are open to participants now.

Browse Thyrotoxicosis studies →

Lead sponsor

S.LAB (SOLOWAYS) is the lead sponsor of 29 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Confirmed presence of one or more specified gene polymorphism r25191G/A SEPP1
  • TPOAb levels > 300 IU/mL

Exclusion criteria

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
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
150 participants (estimated)

Study arms

  • Experimental
    zinc, selenium, and L-tyrosine supplementation

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

  • Placebo comparator
    placebo group

    Other: Placebo

Interventions

  • Dietary supplementzinc, selenium, and L-tyrosine in SEPP1

    zinc, selenium, and L-tyrosine in SEPP1 polymorphism

  • OtherPlacebo

    placebo comparator in SEPP1 polymorphism group

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What researchers measure

Primary outcomes

  1. Percent change of Thyroid Peroxidase Antibodies (TPOAb) in subjects with r25191 SEPP1 polymorphism

    Time frame: 6 months

Secondary outcomes

  1. Percent change in Thyroglobulin Antibodies (TgAb) in subjects with r25191 SEPP1 polymorphism

    Time frame: 6 months

  2. Free Thyroxine (Free T4) change in subjects with r25191 SEPP1 polymorphism

    Time frame: 6 months

  3. Free Triiodothyronine (Free T3) change in subjects with r25191 SEPP1 polymorphism

    Time frame: 6 months

  4. Thyroid Receptor Antibodies (TRAb) change in subjects with r25191 SEPP1 polymorphism

    Time frame: 6 months

  5. TSH Receptor Antibodies (TSHR-Ab) change in subjects with r25191 SEPP1 polymorphism

    Time frame: 6 months

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Study locations

1 site
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 8, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06264544
Lead sponsor
S.LAB (SOLOWAYS)
Collaborators
Center of New Medical Technologies
Responsible party
Sponsor
First posted
Feb 20, 2024
Start date
Jul 30, 2025 (estimated)
Primary completion
Oct 15, 2025 (estimated)
Completion
Dec 30, 2025 (estimated)
Last update
Jun 8, 2025

Study contacts

Andrey V Ponomarenko, MD
Contact
dasyshadoff@gmail.com
9628316017 ext. +7

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.

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