Correction of Selenium Deficiency Has Effect on Thyroid Function
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 主要终点
- comparison of thyroid function
研究概览
简要总结
Previous literature has found potential association between selenium deficiency and inactivated glutathione peroxidase and deiodinase, which may contribute to subsequent elevation of T4 and ratio of T4/T3. Conduction of a case-control study (ID: Liuyanping3) has been applied on Clinicaltrials.gov to further elucidate effect of selenium deficiency on thyroid function. Based on its data, the investigators will perform a randomized, placebo-controlled,single-blinded crossover study on 20 participants with selenium deficiency to verify health consequence of selenium.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
盲法说明
All participants will be blinded. Both the selenium-rich corn powder and the ordinary corn powder (placebo) have the same smell, color and taste.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of selenium deficiency through serum selenium test in previous phase (ID: Liuyanping3) of the study
- •Should have stable body weight in the latest 3 months;
- •Should be not prescribed with thyroid hormone replacement therapy
- •Should be without medical history of thyroid surgery or iodine radiotherapy
- •Should have normal FT3, FT4 and TSH.
排除标准
- •Clinical diagnosis of acute critical illness in the latest 1 year
- •Have had weight fluctuation by more than 5%
- •Eating disorders
- •Neuropsychological disorders
- •Allergy to corn or yeast
研究组 & 干预措施
A
Participants will be administered firstly selenium-rich corn powder 20g/d for 1 month and ordinary corn powder 20g/d for another month subsequently with a month washout period.
干预措施: selenium supplementation (Dietary Supplement)
A
Participants will be administered firstly selenium-rich corn powder 20g/d for 1 month and ordinary corn powder 20g/d for another month subsequently with a month washout period.
干预措施: ordinary corn powder (Dietary Supplement)
B
Participants will be administered firstly ordinary corn powder 20g/d for 1 month and selenium-rich corn powder 20g/d for another month subsequently with a month washout period.
干预措施: selenium supplementation (Dietary Supplement)
B
Participants will be administered firstly ordinary corn powder 20g/d for 1 month and selenium-rich corn powder 20g/d for another month subsequently with a month washout period.
干预措施: ordinary corn powder (Dietary Supplement)
结局指标
主要结局
comparison of thyroid function
时间窗: plasma sample will be collected at -1w/4w/8w/12w
comparison of thyroid function between administration of selenium supplementation and placebo
次要结局
- comparison of serum selenium(plasma sample will be collected at -1w/4w/8w/12w)
- comparison of erythrocyte glutathione peroxidase activity(plasma sample will be collected at -1w/4w/8w/12w)
- comparison of serum deiodinase activity(plasma sample will be collected at -1w/4w/8w/12w)
研究者
Liuyanping
nutrition physician
Peking Union Medical College Hospital