Restless Legs SyndromePhase 2/3NCT02256215
Vitamin D in the Treatment of Primary Restless Legs Syndrome
A Phase 2/3 study testing Vitamin D in people with Restless Legs Syndrome, run by King Abdulaziz University.
Trial summary
Restless Legs Syndrome (RLS) is a sensorimotor disorder that syndrome may substantially interfere with normal sleep, leading to significant impairment in patients' productivity and quality of life. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Restless Legs Syndrome
- 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
- 106 participants
- Where
- No sites listed yet
- Study dates
- Dec 2015to Dec 2017
- Phase
- Phase 2/3
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Newly diagnosed or already diagnosed patients with primary RLS and vitamin D deficiency.
- Patients that are not currently receiving any treatment for RLS or vitamin D replacement therapy.
- Patients from 18 to 75 years old.
- Patients otherwise are in good general health.
Who cannot join
- Patients diagnosed with secondary RLS. i.e.: patients with:
- 1. Iron deficiency anemia 2. End-stage renal disease. 3. Diabetes mellitus (DM). 4. Peripheral neuropathy. 5. Multiple sclerosis (MS). 6. Pregnancy.
- 2. Patients with other mimicking disorders or primary sleep disorders. E.g.:
- Arthritis.
- Deep venous thrombosis.
- Varicose veins or venous insufficiency.
Show all 27Show fewer
- Habitual foot tapping.
- 3. Patients receiving medications that can trigger RLS. i.e.:
- Anti hypertensive medications. E.g. Use of thiazide diuretics at a total dose greater than 37.5 mg/day.
- Anti convulsion medications.e.g. Use of anticonvulsant drug started within 6 months of screening. Stable regimen of anticonvulsants is allowed.
- Antinausea drugs (prochlorperazine or metoclopramide).
- Antipsychotic drugs (haloperidol or phenothiazine derivatives).
- Anti depressants (SSRIs).
- Antihistamines as in cold and allergy medications.
- 4. Patients with current medications or conditions that would interfere with vitamin D absorption:
- 1. Celiac disease. 2. Chron's disease. 3. Chronic pancreatitis. 4. Cystic fibrosis. 5. Weight-loss drug e.g. orlistat. 6. Cholesterol-lowering drug e.g. cholestyramine
- 5. Patients with contraindications for vitamin D supplements. i.e.:
- Hyperparathyroidism.
- Kidney stones.
- Liver diseases.
- Granulomatous disorders (sarcoidosis, tuberculosis)
- 6. Patients 17 years old and younger.
- 7. Use of supplements containing vitamin D at total doses higher than 1000 IU/day within 12 weeks of the baseline visit initiating the protocol and unwillingness to limit vitamin D supplementation dosage to no higher than 1000 IU/day for the duration of the study.
- 8. Use of supplements containing calcium at total doses higher than 600 mg/day within 1 week of the baseline visit initiating the protocol and unwillingness to limit calcium supplementation dosage to no more than 600 mg/day for the duration of the study.
- 9. History of intolerance to vitamin D supplements.
- 10. Women only: A. Pregnancy (past 1 year by report or positive pregnancy test at screening), intent to become pregnant in the next 4 years or unprotected intercourse. History of gestational diabetes is not an exclusion criterion.
- Currently breastfeeding. C. Use of oral contraceptives or menopausal hormone therapy started within 3 months of baseline. Stable regimen of oral contraceptives or any other hormonal method of contraception (e.g. implantable) is allowed.
About this study
Official title: Vitamin D in the Treatment of Primary Restless Legs Syndrome: 12 Weeks, Triple-blinded, Randomized, Placebo-controlled Trial
Restless Legs Syndrome (RLS) is a sensorimotor disorder that syndrome may substantially interfere with normal sleep, leading to significant impairment in patients' productivity and quality of life.
The most common and potent of all treatment regimens are the dopaminergic agonist agents, which carry serious adverse events in their prolonged use despite their augmentation. A few basic studies have suggested a potential relationship between vitamin D and RLS. It has been implicated that dopaminergic system dysfunction plays a role in the development of RLS, while vitamin D has a protective effect on that system. This has been further substantiated by few clinical observations that showed prompt improvement of RLS patients upon receiving dopaminergic agents such as carbamazepine. Other studies have revealed low serum levels of vitamin D in RLS patients, along with remarkable improvement after vitamin D replacement therapy, as has been demonstrated in a recent pilot study.
Read more
This collectively points at vitamin D as a potential, more natural and safer treatment option for those suffering from RLS. However, the role of vitamin D in RLS has not been effectively investigated. The aim of this 12-week, triple-blinded, randomized, placebo-controlled trial is to confirm the relationship between vitamin D deficiency and RLS and hence elucidate the efficacy of vitamin D replacement therapy in reducing the severity of RLS, with predictions that the results will contribute to better understanding of the disease and its management.
Methods and Materials: This 12-week, double-blinded, randomized, placebo-controlled trial is take place over a duration of 2 years. It will be held in the city of Jeddah to assess a sample of Saudi residents of the Western region.
It is comprised of a number of visits, with the first one consisting of a questionnaire that is to be answered regarding RLS, physical examination, electromyography, the objective multiple Suggested Immobilization test, and blood tests. The main purpose of the second visit is to establish a diagnosis of RLS.
Clinic visits number 3 through 6 comprise the pre-randomizaiton phase. Their purpose is to determine the patient's adherence to trial procedures and pharmacological treatment.
Then, patients are to visit the clinic every two weeks for the first two months, then at week 12. Patients will be assessed in regards to treatment response and adverse effects through history and physical examination along with further blood tests.
Aim: to confirm the relationship between vitamin D deficiency and RLS and hence elucidate the efficacy of vitamin D replacement therapy in reducing the severity of RLS, with predictions that the results will contribute to better understanding of the disease and its management.
- Conditions
- Restless Legs Syndrome
- Being tested
- Vitamin D
- Keywords
- Vitamin D
- Medical subject headings
- Restless Legs Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin DDrug
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D | Experimental | • All patients will have their serum vitamin D levels measured at the baseline visit. Those assigned to the treatment arm (group A) will receive either 50,000 international units of vitamin D3 by mouth once or more per week for six to eight weeks, then 800 to 1000 (or more) international units of vitamin D3 daily thereafter, this is according to the recommendations of the Endocrine Society clinical practice guideline 2011. Group B patients will receive placebo supplements identical in appearance to the vitamin D supplements. Receives: Drug: Vitamin D |
| Placebo | Placebo comparator | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in The International Restless Legs Scale (IRLS) total score
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2014 (estimated)
- Study startDec 2015
- Primary completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Restless Legs SyndromeStudies of the same condition, open and under way.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Abdulaziz University
- Sponsor type
- University, hospital or other
- Collaborators
- King AbdulAziz City for Science and Technology
- Responsible party
- Principal investigator, Siraj Omar Wali, King Abdulaziz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02256215
- Sponsor's protocol ID
- RLSD-1234
- Status last verified
- Apr 2015
- First submitted
- 1 Oct 2014
- Last updated
- 6 Apr 2015
- Results posted
- No
Publications
Wali SO, Abaalkhail B, Alhejaili F, Pandi-Perumal SR. Efficacy of vitamin D replacement therapy in restless legs syndrome: a randomized control trial. Sleep Breath. 2019 Jun;23(2):595-601. doi: 10.1007/s11325-018-1751-2. Epub 2018 Nov 14.
PubMed 30430372
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D in the Treatment of Primary Restless Legs Syndrome: 12 Weeks, Triple-blinded, Randomized, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT02256215
- Acronym / sponsor ID
- RLSD-1234
- Conditions
- Restless Legs Syndrome
- Keywords
- Vitamin D
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- King Abdulaziz UniversityUniversity, hospital or other
- Collaborators
- King AbdulAziz City for Science and Technology
- Study start
- Dec 2015
- Primary completion
- Dec 2017 (estimated)
- First posted
- 3 Oct 2014 (estimated)
- 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 Legs Syndrome (RLS) is a sensorimotor disorder that syndrome may substantially interfere with normal sleep, leading to significant impairment in patients' productivity and quality of life.
The most common and potent of all treatment regimens are the dopaminergic agonist agents, which carry serious adverse events in their prolonged use despite their augmentation. A few basic studies have suggested a potential relationship between vitamin D and RLS. It has been implicated that dopaminergic system dysfunction plays a role in the development of RLS, while vitamin D has a protective effect on that system. This has been further substantiated by few clinical observations that showed prompt improvement of RLS patients upon receiving dopaminergic agents such as carbamazepine. Other studies have revealed low serum levels of vitamin D in RLS patients, along with remarkable improvement after vitamin D replacement therapy, as has been demonstrated in a recent pilot study.
This collectively points at vitamin D as a potential, more natural and safer treatment option for those suffering from RLS. However, the role of vitamin D in RLS has not been effectively investigated. The aim of this 12-week, triple-blinded, randomized, placebo-controlled trial is to confirm the relationship between vitamin D deficiency and RLS and hence elucidate the efficacy of vitamin D replacement therapy in reducing the severity of RLS, with predictions that the results will contribute to better understanding of the disease and its management.
Methods and Materials: This 12-week, double-blinded, randomized, placebo-controlled trial is take place over a duration of 2 years. It will be held in the city of Jeddah to assess a sample of Saudi residents of the Western region.
It is comprised of a number of visits, with the first one consisting of a questionnaire that is to be answered regarding RLS, physical examination, electromyography, the objective multiple Suggested Immobilization test, and blood tests. The main purpose of the second visit is to establish a diagnosis of RLS.
Clinic visits number 3 through 6 comprise the pre-randomizaiton phase. Their purpose is to determine the patient's adherence to trial procedures and pharmacological treatment.
Then, patients are to visit the clinic every two weeks for the first two months, then at week 12. Patients will be assessed in regards to treatment response and adverse effects through history and physical examination along with further blood tests.
Aim: to confirm the relationship between vitamin D deficiency and RLS and hence elucidate the efficacy of vitamin D replacement therapy in reducing the severity of RLS, with predictions that the results will contribute to better understanding of the disease and its management.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D | Experimental | Drug: Vitamin D• All patients will have their serum vitamin D levels measured at the baseline visit. Those assigned to the treatment arm (group A) will receive either 50,000 international units of vitamin D3 by mouth once or more per week for six to eight weeks, then 800 to 1000 (or more) international units of vitamin D3 daily thereafter, this is according to the recommendations of the Endocrine Society clinical practice guideline 2011. Group B patients will receive placebo supplements identical in appearance to the vitamin D supplements. |
| Placebo | Placebo comparator | – |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Newly diagnosed or already diagnosed patients with primary RLS and vitamin D deficiency.
- Patients that are not currently receiving any treatment for RLS or vitamin D replacement therapy.
- Patients from 18 to 75 years old.
- Patients otherwise are in good general health.
Key exclusion criteria (27 listed)
- Patients diagnosed with secondary RLS. i.e.: patients with:
- 1. Iron deficiency anemia 2. End-stage renal disease. 3. Diabetes mellitus (DM). 4. Peripheral neuropathy. 5. Multiple sclerosis (MS). 6. Pregnancy.
- Arthritis.
- Deep venous thrombosis.
- Varicose veins or venous insufficiency.
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 D | Drug | Vitamin D |
Primary outcome
Change in The International Restless Legs Scale (IRLS) total score
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2015.
- Derived from this study: PubMed 30430372Wali SO, Abaalkhail B, Alhejaili F, Pandi-Perumal SR. Efficacy of vitamin D replacement therapy in restless legs syndrome: a randomized control trial. Sleep Breath. 2019 Jun;23(2):595-601. doi: 10.1007/s11325-018-1751-2. Epub 2018 Nov 14.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Vitamin D in people with Restless Legs Syndrome, run by King Abdulaziz University.
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 4 inclusion and 27 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: status not confirmed, as of the sponsor's last update on 6 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Change in The International Restless Legs Scale (IRLS) total score (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02256215, which also lists 1 linked publication.
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 6 Apr 2015.