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

University of Sao Paulo General Hospital

Status and phase: Withdrawn; Phase 4

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

Treatments: Drug: Vitamin D; Drug: Placebo Oral Tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT03063190

RLS vitamin D

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 4 patient groups, including a placebo group

Hyperparathyroidism_0

Placebo Comparator group

Description:

Chronic Kidney Disease patients with parathyroid hormone higher than 300pg/ml

Treatment:

Drug: Placebo Oral Tablet

Hyperparathyroidism_1

Active Comparator group

Description:

Chronic Kidney Disease patients with parathyroid hormone higher than 300pg/ml

Treatment:

Drug: Vitamin D

Adynamic_0

Placebo Comparator group

Description:

Chronic Kidney Disease patients with parathyroid hormone lower than 150pg/ml

Treatment:

Drug: Placebo Oral Tablet

Adynamic_1

Active Comparator group

Description:

Chronic Kidney Disease patients with parathyroid hormone lower than 150pg/ml

Treatment:

Drug: Vitamin D