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

Phase 4

Withdrawn

• Conditions: Renal Disease Bone; Hyperparathyroidism, Secondary; Renal Disease, End Stage; Adynamic Bone Disease; Restless Leg Disorder; Vitamin D Deficiency
• Interventions: Drug: Vitamin D; Drug: Placebo Oral Tablet

• Registration Number: NCT03063190
• Lead Sponsor: University of Sao Paulo General Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-02-21
• Study First Submitted QC: 2017-02-21
• Study First Posted: 2017-02-24
• Status Verified: 2019-10
• Last Update Submitted: 2021-09-29
• Last Update Posted: 2021-09-30
• Study Start: 2022-03-31
• Primary Completion: 2022-03-31
• Study Completion: 2023-03

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hyperparathyroidism_1	Vitamin D	Chronic Kidney Disease patients with parathyroid hormone higher than 300pg/ml
Adynamic_0	Placebo Oral Tablet	Chronic Kidney Disease patients with parathyroid hormone lower than 150pg/ml
Hyperparathyroidism_0	Placebo Oral Tablet	Chronic Kidney Disease patients with parathyroid hormone higher than 300pg/ml
Adynamic_1	Vitamin D	Chronic Kidney Disease patients with parathyroid hormone lower than 150pg/ml

Primary Outcome Measures

Name	Time	Method
Improvement RLS severity	6 months	Reduction of the disease's symptoms

Trial Locations

Locations (1)

Hospital das Clinicas; 🇧🇷 Sao Paulo, SP, Brazil