Cholecalciferol Supplementation in Restless Leg Syndrome in Patients With Chronic Kidney Disease
Status:
Withdrawn
Trial end date:
2023-03-01
Target enrollment:
Participant gender:
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.