Evaluation of Cholecalciferol Supplementation in Chronic Kidney Disease Patients With Restless Leg Syndrome
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Improvement RLS severity
研究概览
简要总结
Restless leg syndrome (RLS) is sleep disorder characterized by an unpleasant feeling in the lower limbs, which can be accompanied by paresthesias, and need for urgent movement of the legs. Its diagnosis is clinical, based on an International Committee of the Study of RLS (International Restless Legs Syndrome Study) questionnaire. Its prevalence is about 5-15% in the general population, being twice as frequent in women and with a tendency to increase incidence with aging. In the chronic kidney disease (CKD) population, mainly in patients on dialysis, the prevalence increases by up to 70%. Vitamin D deficiency is associated with RLS and active vitamin D supplementation seems to improve RLS and severity. It is seems, studies on the role of vitamin D supplementation in CKD population are missing. The clinical-scientific hypothesis of this study is that replacement of vitamin D (cholecalciferol) will improve the symptoms of RLS. As parathyroidectomy can relieve RLS, the aim of researchers is to randomize patients with CKD on dialysis to receive cholecalciferol or placebo in 2 distinct groups: secondary hyperparathyroidism and adynamic bone disease.
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
- Double (Participant, 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Hyperparathyroidism_0
Chronic Kidney Disease patients with parathyroid hormone higher than 300pg/ml
干预措施: Placebo Oral Tablet (Drug)
Hyperparathyroidism_1
Chronic Kidney Disease patients with parathyroid hormone higher than 300pg/ml
干预措施: Vitamin D (Drug)
Adynamic_0
Chronic Kidney Disease patients with parathyroid hormone lower than 150pg/ml
干预措施: Placebo Oral Tablet (Drug)
Adynamic_1
Chronic Kidney Disease patients with parathyroid hormone lower than 150pg/ml
干预措施: Vitamin D (Drug)
结局指标
主要结局
Improvement RLS severity
时间窗: 6 months
Reduction of the disease's symptoms
次要结局
未报告次要终点
