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临床试验/NCT06264544
NCT06264544尚未招募不适用

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

S.LAB (SOLOWAYS)2 个研究点 分布在 2 个国家目标入组 150 人开始时间: 2025年7月30日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
150
试验地点
2
主要终点
Percent change of Thyroid Peroxidase Antibodies (TPOAb) in subjects with r25191 SEPP1 polymorphism

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Care Provider)

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

结局指标

主要结局

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

时间窗: 6 months

次要结局

  • Free Triiodothyronine (Free T3) change in subjects with r25191 SEPP1 polymorphism(6 months)
  • 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)
  • Thyroid Receptor Antibodies (TRAb) change in subjects with r25191 SEPP1 polymorphism(6 months)

研究者

发起方
S.LAB (SOLOWAYS)
申办方类型
Other
责任方
Sponsor

研究点 (2)

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