Last updated: February 15, 2023
Sponsor: OSF Healthcare System
Overall Status: Active - Recruiting
Phase
N/A
Condition
Williams Syndrome
Manic Disorders
Dyskinesias
Treatment
N/AClinical Study ID
NCT04462796
1567451
Ages 18-89 All Genders
Study Summary
Eligibility Criteria
Inclusion
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
Exclusion Criteria:
- Patients who are currently taking magnesium supplements or took magnesium supplementsin 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 includeantidepressants such as SSRIs, SNRIs and TCAs and Antihistamines such as Benadryl andAllegra, etc)
- Patients with a history of chronic kidney disease or end-stage renal disease onHemodialysis
- 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 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
Connect with a study center
OSF Healthcare Illinois Neurological Institute
Peoria, Illinois 61603
United StatesActive - Recruiting
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