Vitamin D in the Treatment of Primary Restless Legs Syndrome
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|ClinicalTrials.gov Identifier: NCT02256215|
Recruitment Status : Unknown
Verified April 2015 by Siraj Omar Wali, King Abdulaziz University.
Recruitment status was: Not yet recruiting
First Posted : October 3, 2014
Last Update Posted : April 6, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Restless Legs Syndrome||Drug: Vitamin D||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||106 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Vitamin D in the Treatment of Primary Restless Legs Syndrome: 12 Weeks, Triple-blinded, Randomized, Placebo-controlled Trial|
|Study Start Date :||December 2015|
|Estimated Primary Completion Date :||December 2017|
Experimental: 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.
Drug: Vitamin D
|Placebo Comparator: Placebo|
- Change in The International Restless Legs Scale (IRLS) total score [ Time Frame: 12 weeks ]