The DAGMAR Study. D-vitamin And Graves' Disease; Morbidity And Relapse Reduction: A Randomised, Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 278
- 试验地点
- 16
- 主要终点
- Proportion of participants without relapse within the first year after cessation of ATD treatment.
研究概览
简要总结
The purpose of this study is to investigate the effects of vitamin D supplementation on morbidity and risk of relapse in patients with Graves' disease.
详细描述
In a multicentre trial, 260 patients with newly diagnosed Graves ' disease will be randomized to cholecalciferol 70 mcg/day or placebo in a parallel Group design. Drop outs prior to 31th of December 2017 will be replaced. The intervention will continue during treatment with antithyroid drugs (ATD), and for a period of 12 months after cessation of ATD. Blood samples will be collected at study entry, at 3 and 9 months, and at end of study. QoL questionnaires on nine occasions through out the study period. In a subcohort of 80 participants detailed examinations of bone density and geometry, muscle strength and postural balance, immune tests (N=50), and measurements of arterial stiffness will be performed at study entry, and at 3 and 9 months after randomisation.
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
- Triple (Participant, Care Provider, Investigator)
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
- •A first time diagnosis of Graves' hyperthyroidism within the last three months, confirmed by TSH below 0.01 IU/L, and T3 or T4 levels above the reference interval necessitating ATD therapy
- •Positive TRAb
- •Speak and read Danish
- •Written informed consent
排除标准
- •Previously diagnosed hyperthyroidism
- •ATD treatment initiated more than 3 months prior to inclusion
- •Planned ablative therapy (radioactive iodine or thyroid surgery)
- •Intake of more than 10 µg D-vitamin/day that the participant wishes to continue.
- •Chronic granulomatous illness
- •Persistent hypercalcemia (plasma calcium > 1.40 mmol/L)
- •Reduced kidney function (eGFR < 45 ml/min)
- •Treatment with immunomodulatory drugs
- •Active malignant disease
- •Alcohol or drug abuse
- •Pregnancy at inclusion
- •Major comorbidity, making the participant unlikely to continuously receive trial intervention.
- •Allergy towards the components in the D-vitamin or the placebo pills.
- •Unable to read and understand Danish
- •Lack of informed consent.
结局指标
主要结局
Proportion of participants without relapse within the first year after cessation of ATD treatment.
时间窗: 0-12 months after cessation of ATD treatment
A relapse is defined as: The participant has been referred to radioactive iodine or thyroid surgery at any time during the entire intervention period; or The participant has hyperthyroidism (TSH\<0.1) at 12 months (+/- 1 months) after cessation of ATD treatment; or ATD is re-initiated within 12 months after cessation of initial ATD treatment; or The participant fails to stop ATD treatment within 24 months after initiation of ATD treatment.
次要结局
- Effects of D-vitamin supplementation according to plasma level of D-vitamin at inclusion to the study.(From randomisation until 12 months after cessation of ATD treatment, an expected average of 24 months)
- Quality of Life as measured by Health questionnaires(24 months)
- The proportion of participants who has been referred to radioactive iodine or thyroid surgery at any time during the entire intervention period.(From randomisation until 12 months after cessation of ATD treatment, an expected average of 24 months)
- The proportion of participants who have relapse of hyperthyroidism (TSH<0.1) after cessation of ATD therapy(0-12 months after cessation of ATD treatment)
- Level of 25 hydroxy vitamin D(From randomisation until 12 months after cessation of ATD treatment, an expected average of 24 months)
- The proportion of participants who re-initiates ATD treatment or is referred to radioactive iodine or thyroid surgery due to hyperthyroidism within 12 months after cessation of initial ATD treatment.(0-12 months after cessation of ATD treatment)
- The proportion of participants who fails to stop ATD treatment within 24 months after initiation of ATD therapy.(0-24 months after initiation of ATD therapy)
- Proportion of participants without relapse within the first year after cessation of ATD treatment according to baseline use of D-vitamin.(From randomisation until 12 months after cessation of ATD treatment, an expected average of 24 months)
- Biomarkers of calcium- and bone metabolism.(3 months, 9 months and 12 months after cessation of ATD treatment, an expected average of 24 months)
- Level of Thyrotropin receptor antibody (TRAb)(3 months, 9 months and 12 months after cessation of ATD treatment, an expected average of 24 months)