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

NCT03063190 | Withdrawn Phase 4 DMC

• 1 other identifier: RLS vitamin D
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Improvement RLS severity

  Reduction of the disease's symptoms

  6 months

Study Arms (4)

Hyperparathyroidism_0

PLACEBO COMPARATOR

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

Drug: Placebo Oral Tablet

Hyperparathyroidism_1

ACTIVE COMPARATOR

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

Drug: Vitamin D

Adynamic_0

PLACEBO COMPARATOR

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

Drug: Placebo Oral Tablet

Adynamic_1

ACTIVE COMPARATOR

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

Drug: Vitamin D

Interventions

Vitamin D DRUG

patients will receive vitamin D supplementation according to guidelines

Adynamic_1; Hyperparathyroidism_1

Placebo Oral Tablet DRUG

patients will receive placebo oral tablets

Adynamic_0; Hyperparathyroidism_0

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- adult patients with chronic kidney disease on dialysis, with vitamin D deficiency.

You may not qualify if:

• current treatment for restless leg syndrome
• history of parathyroidectomy in the last 6 months

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

Hospital das Clinicas

São Paulo, São Paulo, 05403-000, Brazil

Location

MeSH Terms

Conditions

Restless Legs Syndrome; Chronic Kidney Disease-Mineral and Bone Disorder; Kidney Failure, Chronic; Hyperparathyroidism, Secondary; Vitamin D Deficiency

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Parasomnias; Mental Disorders; Rickets; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Calcium Metabolism Disorders; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Hyperparathyroidism; Parathyroid Diseases; Endocrine System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Renal Insufficiency, Chronic; Renal Insufficiency

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2017
• First Posted: February 24, 2017
• Study Start: March 31, 2022
• Primary Completion: March 31, 2022
• Study Completion: March 1, 2023
• Last Updated: September 30, 2021

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)