Cholecalciferol Supplementation in Restless Leg Syndrome in Patients With Chronic Kidney Disease (RLS)
Primary Purpose
Restless Leg Disorder, Renal Disease Bone, Renal Disease, End Stage
Status
Withdrawn
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Vitamin D
Placebo Oral Tablet
Sponsored by
About this trial
This is an interventional treatment trial for Restless Leg Disorder
Eligibility Criteria
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
Sites / Locations
- Hospital das Clinicas
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Placebo Comparator
Active Comparator
Placebo Comparator
Active Comparator
Arm Label
Hyperparathyroidism_0
Hyperparathyroidism_1
Adynamic_0
Adynamic_1
Arm Description
Chronic Kidney Disease patients with parathyroid hormone higher than 300pg/ml
Chronic Kidney Disease patients with parathyroid hormone higher than 300pg/ml
Chronic Kidney Disease patients with parathyroid hormone lower than 150pg/ml
Chronic Kidney Disease patients with parathyroid hormone lower than 150pg/ml
Outcomes
Primary Outcome Measures
Improvement RLS severity
Reduction of the disease's symptoms
Secondary Outcome Measures
Full Information
NCT ID
NCT03063190
First Posted
February 21, 2017
Last Updated
September 29, 2021
Sponsor
University of Sao Paulo General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03063190
Brief Title
Cholecalciferol Supplementation in Restless Leg Syndrome in Patients With Chronic Kidney Disease
Acronym
RLS
Official Title
Evaluation of Cholecalciferol Supplementation in Chronic Kidney Disease Patients With Restless Leg Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Withdrawn
Why Stopped
the main research is no longer in the Institution
Study Start Date
March 31, 2022 (Anticipated)
Primary Completion Date
March 31, 2022 (Anticipated)
Study Completion Date
March 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Sao Paulo General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Restless Leg Disorder, Renal Disease Bone, Renal Disease, End Stage, Hyperparathyroidism, Secondary, Adynamic Bone Disease, Vitamin D Deficiency
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hyperparathyroidism_0
Arm Type
Placebo Comparator
Arm Description
Chronic Kidney Disease patients with parathyroid hormone higher than 300pg/ml
Arm Title
Hyperparathyroidism_1
Arm Type
Active Comparator
Arm Description
Chronic Kidney Disease patients with parathyroid hormone higher than 300pg/ml
Arm Title
Adynamic_0
Arm Type
Placebo Comparator
Arm Description
Chronic Kidney Disease patients with parathyroid hormone lower than 150pg/ml
Arm Title
Adynamic_1
Arm Type
Active Comparator
Arm Description
Chronic Kidney Disease patients with parathyroid hormone lower than 150pg/ml
Intervention Type
Drug
Intervention Name(s)
Vitamin D
Intervention Description
patients will receive vitamin D supplementation according to guidelines
Intervention Type
Drug
Intervention Name(s)
Placebo Oral Tablet
Intervention Description
patients will receive placebo oral tablets
Primary Outcome Measure Information:
Title
Improvement RLS severity
Description
Reduction of the disease's symptoms
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Hospital das Clinicas
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
05403-000
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Cholecalciferol Supplementation in Restless Leg Syndrome in Patients With Chronic Kidney Disease
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