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

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

Status
Withdrawn
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03063190
Acronym
RLS
Enrollment
0
Registered
2017-02-24
Start date
2022-03-31
Completion date
2023-03-31
Last updated
2021-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

DRUGVitamin D

patients will receive vitamin D supplementation according to guidelines

DRUGPlacebo Oral Tablet

patients will receive placebo oral tablets

Sponsors

University of Sao Paulo General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Improvement RLS severity6 monthsReduction of the disease's symptoms

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026