Clinical trial NCT04462796: The Effect of Magnesium Citrate Supplementation in Restless Legs Syndrome (RLS)
Official title: The Effect of Magnesium Citrate Supplementation in Patients With Restless Legs Syndrome (RLS) - An Open Label, Prospective, Non Placebo Controlled Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Restless Legs Syndrome
Keywords: RLS, Magnesium Citrate, Magnesium
Lead sponsor: OSF Healthcare System
Sponsor class: OTHER
First posted: 2020-07-08
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pilot study
Primary purpose: OTHER

Brief summary: 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. Patients who are currently taking magnesium supplements or took magnesium supplements in the last 3 months.
2. 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)
3. Patients with a history of chronic kidney disease or end-stage renal disease on Hemodialysis
4. Patients with known allergies to magnesium citrate
5. 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.
6. Patients with diarrhea
7. Patients on gabapentin or pregabalin for pain syndromes
8. 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).

Primary outcomes:
measure: Subjective Improvement of Restless Legs Symptoms measured by the International Restless Legs Syndrome Scale (IRLS)
timeFrame: Completion of Study participation at 8 weeks
measure: Subjective Improvement of Restless Legs Symptoms measured by the Kohnen Kohnen Restless Legs Syndrome Quality of Life Instrument (KRLS QOL)
timeFrame: Completion of Study participation at 8 weeks
measure: Objective Improvement of Restless Legs Symptoms: Multiple Suggested Immobilization test (MSI) Score
timeFrame: Completion of Study participation at 8 weeks
measure: Correlation of magnesium levels with Kohnen Restless Legs Syndrome Quality of Life Instrument (KRLS) and Multiple Suggested Immobilization test (MSI) scores
timeFrame: Completion of Study participation at 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Peoria
country: United States
facility: OSF Healthcare Illinois Neurological Institute
state: Illinois
Study officials:
affiliation: OSF Healthcare Saint Francis Medical Center
name: Sasikanth Gorantla, MD
role: PRINCIPAL_INVESTIGATOR
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