Vitamin D in the Treatment of Primary Restless Legs Syndrome

NCT02256215 | Unknown Phase 2

• 1 other identifier: RLSD-1234
• Study Type: interventional
• Target: 106
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Restless Legs Syndrome

Keywords

Vitamin D

Outcome Measures

Primary Outcomes (1)

• Change in The International Restless Legs Scale (IRLS) total score

  12 weeks

Study Arms (2)

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.

Drug: Vitamin D

Placebo

PLACEBO COMPARATOR

Interventions

Vitamin D DRUG

Vitamin D

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients diagnosed with secondary RLS. i.e.: patients with:
• \. Iron deficiency anemia 2. End-stage renal disease. 3. Diabetes mellitus (DM). 4. Peripheral neuropathy. 5. Multiple sclerosis (MS). 6. Pregnancy.
• \. Patients with other mimicking disorders or primary sleep disorders. E.g.:
• Arthritis.
• Deep venous thrombosis.
• Varicose veins or venous insufficiency.
• Habitual foot tapping.
• \. 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.
• \. Patients with current medications or conditions that would interfere with vitamin D absorption:

Sponsors & Collaborators

• King Abdulaziz University: lead
• King AbdulAziz City for Science and Technology: collaborator

Related Publications (1)

• 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.

  PMID: 30430372 DERIVED

MeSH Terms

Conditions

Restless Legs Syndrome

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Parasomnias; Mental Disorders

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: October 1, 2014
• First Posted: October 3, 2014
• Study Start: December 1, 2015
• Primary Completion: December 1, 2017
• Last Updated: April 6, 2015

Record last verified: 2015-04