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临床试验/NCT03063190
NCT03063190撤回4 期

Evaluation of Cholecalciferol Supplementation in Chronic Kidney Disease Patients With Restless Leg Syndrome

University of Sao Paulo General Hospital1 个研究点 分布在 1 个国家开始时间: 2022年3月31日最近更新:
适应症
干预措施
相关药物

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

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Hyperparathyroidism_0

Placebo Comparator

Chronic Kidney Disease patients with parathyroid hormone higher than 300pg/ml

干预措施: Placebo Oral Tablet (Drug)

Hyperparathyroidism_1

Active Comparator

Chronic Kidney Disease patients with parathyroid hormone higher than 300pg/ml

干预措施: Vitamin D (Drug)

Adynamic_0

Placebo Comparator

Chronic Kidney Disease patients with parathyroid hormone lower than 150pg/ml

干预措施: Placebo Oral Tablet (Drug)

Adynamic_1

Active Comparator

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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