Restless Leg DisorderPhase 4RLSNCT03063190
Cholecalciferol Supplementation in Restless Leg Syndrome in Patients With Chronic Kidney Disease
A Phase 4 study testing Vitamin D in people with Restless Leg Disorder and Renal Disease Bone, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Restless Leg Disorder, Renal Disease Bone, Renal Disease, End Stage
- What is being tested?
- Vitamin D
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteBrazil
- Study dates
- 31 Mar 2022to Mar 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult patients with chronic kidney disease on dialysis, with vitamin D deficiency.
Who cannot join
- current treatment for restless leg syndrome
- history of parathyroidectomy in the last 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Cholecalciferol Supplementation in Chronic Kidney Disease Patients With Restless Leg Syndrome
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
- Being tested
- Vitamin D, Placebo Oral Tablet
- Medical subject headings
- Restless Legs Syndrome, Chronic Kidney Disease-Mineral and Bone Disorder, Kidney Failure, Chronic, Hyperparathyroidism, Secondary, Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin DDrug
patients will receive vitamin D supplementation according to guidelines
Placebo Oral TabletDrug
patients will receive placebo oral tablets
| Study group | Role | What they receive |
|---|---|---|
| Hyperparathyroidism_0 | Placebo comparator | Chronic Kidney Disease patients with parathyroid hormone higher than 300pg/ml Receives: Drug: Placebo Oral Tablet |
| Hyperparathyroidism_1 | Active comparator | Chronic Kidney Disease patients with parathyroid hormone higher than 300pg/ml Receives: Drug: Vitamin D |
| Adynamic_0 | Placebo comparator | Chronic Kidney Disease patients with parathyroid hormone lower than 150pg/ml Receives: Drug: Placebo Oral Tablet |
| Adynamic_1 | Active comparator | Chronic Kidney Disease patients with parathyroid hormone lower than 150pg/ml Receives: Drug: Vitamin D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement RLS severity
Reduction of the disease's symptoms
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2017
- Study start31 Mar 2022 (estimated)
- Primary completion31 Mar 2022 (estimated)
- Study completionMar 2023 (estimated)
Why it stopped: the main research is no longer in the Institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Restless Leg DisorderStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03063190
- Sponsor's protocol ID
- RLS vitamin D
- Acronym
- RLS
- Status last verified
- Oct 2019
- First submitted
- 21 Feb 2017
- Last updated
- 30 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Cholecalciferol Supplementation in Chronic Kidney Disease Patients With Restless Leg Syndrome
- ClinicalTrials.gov ID
- NCT03063190
- Acronym / sponsor ID
- RLS / RLS vitamin D
- Conditions
- Restless Leg Disorder, Renal Disease Bone, Renal Disease, End Stage, Hyperparathyroidism, Secondary, Adynamic Bone Disease, Vitamin D Deficiency
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: the main research is no longer in the Institution
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- 31 Mar 2022 (estimated)
- Primary completion
- 31 Mar 2022 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 24 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Hyperparathyroidism_0 | Placebo comparator | Drug: Placebo Oral TabletChronic Kidney Disease patients with parathyroid hormone higher than 300pg/ml |
| Hyperparathyroidism_1 | Active comparator | Drug: Vitamin DChronic Kidney Disease patients with parathyroid hormone higher than 300pg/ml |
| Adynamic_0 | Placebo comparator | Drug: Placebo Oral TabletChronic Kidney Disease patients with parathyroid hormone lower than 150pg/ml |
| Adynamic_1 | Active comparator | Drug: Vitamin DChronic Kidney Disease patients with parathyroid hormone lower than 150pg/ml |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- adult patients with chronic kidney disease on dialysis, with vitamin D deficiency.
Key exclusion criteria (2 listed)
- current treatment for restless leg syndrome
- history of parathyroidectomy in the last 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin Dpatients will receive vitamin D supplementation according to guidelines | Drug | Adynamic_1, Hyperparathyroidism_1 |
| Placebo Oral Tabletpatients will receive placebo oral tablets | Drug | Adynamic_0, Hyperparathyroidism_0 |
Primary outcome
Improvement RLS severity
Time frame: 6 months
Reduction of the disease's symptoms
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vitamin D in people with Restless Leg Disorder and Renal Disease Bone, run by University of Sao Paulo General Hospital at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 30 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement RLS severity (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2021; AzTrials last refreshed its copy on 8 Nov 2026.