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

Description

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.

Conditions

Restless Legs Syndrome

Study Overview

Study Details

Study overview

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.

The Effect of Magnesium Citrate Supplementation in Patients With Restless Legs Syndrome (RLS) - An Open Label, Prospective, Non Placebo Controlled Pilot Study

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

Condition
Restless Legs Syndrome
Intervention / Treatment

-

Contacts and Locations

Peoria

OSF Healthcare Illinois Neurological Institute, Peoria, Illinois, United States, 61603

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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).

Ages Eligible for Study

18 Years to 89 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

OSF Healthcare System,

Sasikanth Gorantla, MD, PRINCIPAL_INVESTIGATOR, OSF Healthcare Saint Francis Medical Center

Study Record Dates

2023-12-31