The Effect of Magnesium Citrate Supplementation in Restless Legs Syndrome (RLS)

OSF Healthcare System

Status

Enrolling

Conditions

Restless Legs Syndrome

Treatments

Dietary Supplement: Magnesium Citrate

Study type

Interventional

Funder types

Other

Identifiers

NCT04462796

1567451

Details and patient eligibility

About

The expected results of this study will have a significant impact on the treatment of RLS/WED patients. Magnesium supplementation (if proven to be beneficial) can be utilized as an inexpensive, safer, biologically plausible alternative to dopamine agonists and α2δ calcium-channel ligands.

Full description

This is an open-label, prospective, non-placebo controlled pilot study. 15 subjects with a diagnosis of restless legs syndrome (ICSD-3 diagnostic criteria) will be recruited from OSF Healthcare Saint Francis Medical Center sleep center and Illinois Neurological Institute. RLS/WED patients who meet inclusion and exclusion criteria during the initial clinic visit will be offered study participation. Standard treatment options will be discussed prior to the enrollment. Patients will be reassured that not participating in the study will not affect the future care they receive at OSF HealthCare. The potential risks and benefits of the study will be provided and, if the patient is interested, informed consent will be obtained. If the subject withdraws consent or does not finish both pre and post evaluation, we will replace the subject with another new recruit. The subject will come to the clinic for 2 visits, a pre-magnesium visit and a post-magnesium visit. Following the completion of the pre-magnesium visit, the subject will be given 200 mg elemental magnesium daily (will be instructed to take with food at dinner) for 8 weeks. Both Visits the following study procedures will be performed: magnesium level, (International Restless Legs Syndrome) IRLS scale, Kohnen Restless Legs Syndrome Quality of Life Instrument (KRLS-QOL) scale and (Multiple Suggested Immobilization (MSI) test. The post magnesium visit will be schedule at the completion of the 8 week dose of magnesium.

Enrollment

15 estimated patients

Sex

All

Ages

18 to 89 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age between 18 and 89.
Treatment naïve patients (who are not taking RLS medications for at least 1 year) without coexisting untreated OSA.
Diagnosed with RLS based on ICSD -3 criteria
INI OSF Sleep medicine outpatient clinic patients.
Patients with the ability to provide informed consent.

Exclusion criteria

Patients who are currently taking magnesium supplements or took magnesium supplements in the last 3 months.
Patients not on a stable dosage of medications ( patients requiring dosage changes) that can cause PLMs or worsen RLS will be excluded ( medications include antidepressants such as SSRIs, SNRIs and TCAs and Antihistamines such as Benadryl and Allegra, etc)
Patients with a history of chronic kidney disease or end-stage renal disease on Hemodialysis
Patients with known allergies to magnesium citrate
Patients with congestive heart failure with an ejection fraction less than 40%, bradycardia with a resting heart rate below 60 and systolic blood pressure less than 90 mm of Hg.
Patients with diarrhea
Patients on gabapentin or pregabalin for pain syndromes
Pregnancy. (Absence of pregnancy will be determined via subject self-reporting only. Subject self-reporting of the absence of pregnancy is sufficient screening because the dosage of Magnesium supplement that subjects will be consuming during the study is well below the NIH Tolerable Upper Intake Levels for pregnancy [see "Dietary Recommendations" below], and has been shown to cause no fetal abnormalities or pregnancy complications at the dosage patients will consume for the study. Subjects will be encouraged to practice appropriate measures to avoid pregnancy throughout the entirety of their study participation).