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

Last updated: February 15, 2023
Sponsor: OSF Healthcare System
Overall Status: Active - Recruiting

Phase

N/A

Condition

Williams Syndrome

Manic Disorders

Dyskinesias

Treatment

N/A

Clinical Study ID

NCT04462796
1567451
  • Ages 18-89
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  1. Patients who are currently taking magnesium supplements or took magnesium supplementsin 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 includeantidepressants such as SSRIs, SNRIs and TCAs and Antihistamines such as Benadryl andAllegra, etc)
  3. Patients with a history of chronic kidney disease or end-stage renal disease onHemodialysis
  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 thedosage of Magnesium supplement that subjects will be consuming during the study iswell below the NIH Tolerable Upper Intake Levels for pregnancy [see "DietaryRecommendations" below], and has been shown to cause no fetal abnormalities orpregnancy complications at the dosage patients will consume for the study. Subjectswill be encouraged to practice appropriate measures to avoid pregnancy throughout theentirety of their study participation).

Study Design

Total Participants: 15
Study Start date:
July 10, 2020
Estimated Completion Date:
December 31, 2023

Study 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.

Connect with a study center

  • OSF Healthcare Illinois Neurological Institute

    Peoria, Illinois 61603
    United States

    Active - Recruiting

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