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

Study Overview
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Brief Summary
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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.

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

Conditions
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Vitamin D Deficiency, Restless Leg Disorder, Renal Disease Bone, Renal Disease, End Stage, Hyperparathyroidism, Secondary, Adynamic Bone Disease

Intervention / Treatment
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* Drug: Vitamin D
* Drug: Placebo Oral Tablet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria - adult patients with chronic kidney disease on dialysis, with vitamin D deficiency. Exclusion Criteria current treatment for restless leg syndrome history of parathyroidectomy in the last 6 months

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Hyperparathyroidism_0<br>Chronic Kidney Disease patients with parathyroid hormone higher than 300pg/ml | Drug: Placebo Oral Tablet<br>* patients will receive placebo oral tablets<br>|
| Active Comparator: Hyperparathyroidism_1<br>Chronic Kidney Disease patients with parathyroid hormone higher than 300pg/ml | Drug: Vitamin D<br>* patients will receive vitamin D supplementation according to guidelines<br>|
| Placebo Comparator: Adynamic_0<br>Chronic Kidney Disease patients with parathyroid hormone lower than 150pg/ml | Drug: Placebo Oral Tablet<br>* patients will receive placebo oral tablets<br>|
| Active Comparator: Adynamic_1<br>Chronic Kidney Disease patients with parathyroid hormone lower than 150pg/ml | Drug: Vitamin D<br>* patients will receive vitamin D supplementation according to guidelines<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement RLS severity | Reduction of the disease's symptoms | 6 months |