Vitamin D in the Treatment of Primary Restless Legs Syndrome
Status:
Unknown status
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
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.