GRAves Selenium Supplementation Trial (GRASS) - an Investigator-initiated Randomised, Blinded, Multicentre Clinical Trial of Selenium Supplementation Versus Placebo in Patients with Graves' Hyperthyroidism
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 431
- 试验地点
- 8
- 主要终点
- Proportion of participants with the composite outcome of 'ATD treatment failure'
研究概览
简要总结
The purpose of this study is to investigate if selenium supplementation to the standard treatment with anti-thyroid drugs in patients with Graves' hyperthyroidism, will lead to a fewer people with anti-thyroid treatment failure and faster remission, in terms of better quality of life during the first year of treatment and more patients staying in remission.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older.
- •Active Graves' hyperthyroidism (suppressed TSH (< 0.1) and positive TRAb) measured within the last two months prior to the inclusion date.
- •Written informed consent
排除标准
- •Major co-morbidity, making the participants unlikely to continuously receive trial intervention in the intervention period.
- •Previous treatment with radioactive iodine.
- •Current ATD treatment having been received for more than two months.
- •Treatment with immunomodulatory drugs, such as cyclosporine A, methotrexate, cyclophosphamide.
- •Allergy towards the components in the selenium and placebo pills.
- •Pregnant or breast-feeding women.
- •Intake of selenium supplementation above 70 µg per day (70 µg corresponds to the amount in a multivitamin tablet).
- •Unable to read and understand Danish.
- •Lack of informed consent
研究组 & 干预措施
Placebo
干预措施: Placebo (Other)
Selenium
干预措施: Selenium (Dietary Supplement)
结局指标
主要结局
Proportion of participants with the composite outcome of 'ATD treatment failure'
时间窗: Last 12 months (± 1 month) of the intervention period
'ATD treatment failure' is defined as: * The participant receives ATD treatment (at any level) during the last 12 months (± 1 month) of the intervention period; or * The participant has thyroid hyperfunction (TSH \<0.1) during the last 12 months (± 1 month) of the intervention period; or * The participant has been referred to ablative therapy (radioactive iodine or thyroid surgery) at some point during the entire intervention period.
次要结局
- Proportion of participants who has been referred to ablative therapy (radioactive iodine or thyroid surgery) at some point during the entire intervention period(Intervention period (24-30 months))
- Proportion of participants who receives ATD treatment (at any level) during the last 12 months (± 1 month) of the intervention period(Last 12 months (± 1 month) of the intervention period)
- Hyperthyroid symptoms (ThyPRO subscale) during first year after randomisation(First year after randomisation)
- Proportion of participants who has thyroid hyperfunction (TSH <0.1) during the last 12 months (± 1 month) of the intervention period(Last 12 months (± 1 month) of the intervention period)
- Eye symptoms (ThyPRO subscale) during first year after randomisation, and at end of the intervention period (24-30 months)(First year after randomisation, and at end of the intervention period (24-30 months))
- Number of participants with adverse reactions during the intervention period(Intervention period (24-30 months))
- Number of participants with serious adverse events during the intervention period(Intervention period (24-30 months))
- Thyroid-specific QoL during the first year after randomisation, and at the end of the intervention period (24-30 months), as measured by the global score in the ThyPRO questionnaire(First year after randomisation, and at the end of the intervention period (24-30 months))
- Level of TRAb at 18 months, and at the end of the intervention period (24-30 months)(18 months, and at the end of the intervention period (24-30 months))
研究者
Per Cramon
Principal Investigator
Rigshospitalet, Denmark