Status:
UNKNOWN
The Effect of Magnesium Citrate Supplementation in Restless Legs Syndrome (RLS)
Lead Sponsor:
OSF Healthcare System
Conditions:
Restless Legs Syndrome
Eligibility:
All Genders
18-89 years
Phase:
NA
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,...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
July 10 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2023
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT04462796
Start Date
July 10 2020
End Date
December 31 2023
Last Update
February 17 2023
Active Locations (1)
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1
OSF Healthcare Illinois Neurological Institute
Peoria, Illinois, United States, 61603