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

Sponsor

University of Sao Paulo General Hospital (Other)

Overall Status

Withdrawn

CT.gov ID

NCT03063190

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Restless Leg Disorder Renal Disease Bone Renal Disease, End Stage Hyperparathyroidism, Secondary Adynamic Bone Disease Vitamin D Deficiency	Drug: Vitamin D Drug: Placebo Oral Tablet	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Mar 31, 2022

Anticipated Primary Completion Date :

Mar 31, 2022

Anticipated Study Completion Date :

Mar 1, 2023

Arms and Interventions

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