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
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
- 否
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)
