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

NCT ID: NCT03063190

Last Updated: 2021-09-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-31

Study Completion Date

2023-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Hyperparathyroidism_0

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

Group Type PLACEBO_COMPARATOR

Placebo Oral Tablet

Intervention Type DRUG

patients will receive placebo oral tablets

Hyperparathyroidism_1

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

Group Type ACTIVE_COMPARATOR

Vitamin D

Intervention Type DRUG

patients will receive vitamin D supplementation according to guidelines

Adynamic_0

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

Group Type PLACEBO_COMPARATOR

Placebo Oral Tablet

Intervention Type DRUG

patients will receive placebo oral tablets

Adynamic_1

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

Group Type ACTIVE_COMPARATOR

Vitamin D

Intervention Type DRUG

patients will receive vitamin D supplementation according to guidelines

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Vitamin D

patients will receive vitamin D supplementation according to guidelines

Intervention Type DRUG

Placebo Oral Tablet

patients will receive placebo oral tablets

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Sao Paulo General Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hospital das Clinicas

São Paulo, São Paulo, Brazil

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Brazil

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

RLS vitamin D

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Cholecalciferol on Hemodialysis Patients
NCT03602430 COMPLETED PHASE2/PHASE3