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

Vitamin D Deficiency Clinical Trial

— RLS  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03063190
• Other study ID #: RLS vitamin D
• Status: Withdrawn
• Phase: Phase 4
• Start date: March 31, 2022
• Est. completion date: March 2023

Study information

• Verified date: October 2019
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2023
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adynamic Bone Disease
• Bone Diseases
• Hyperparathyroidism
• Hyperparathyroidism, Secondary
• Kidney Diseases
• Kidney Failure, Chronic
• Psychomotor Agitation
• Renal Disease Bone
• Renal Disease, End Stage
• Renal Insufficiency, Chronic
• Restless Leg Disorder
• Restless Legs Syndrome
• Vitamin D Deficiency

Intervention

Drug:
• Vitamin D
patients will receive vitamin D supplementation according to guidelines
• Placebo Oral Tablet
patients will receive placebo oral tablets

Locations

Country	Name	City	State
Brazil	Hospital das Clinicas	Sao Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement RLS severity	Reduction of the disease's symptoms	6 months