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Electrolyte Supplement
Magnesium Citrate for Restless Legs Syndrome (RLS Trial)
N/A
Recruiting
Led By Sasikanth Gorantla, MD
Research Sponsored by OSF Healthcare System
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up completion of study participation at 8 weeks
Awards & highlights
RLS Trial Summary
This trial will investigate if magnesium supplementation can help with Restless Legs Syndrome/Willis-Ekbom Disease, providing a cheaper, safer alternative to current treatments.
Who is the study for?
This trial is for adults aged 18-89 with Restless Legs Syndrome who haven't taken RLS medications in the last year and don't have severe heart issues, low blood pressure, chronic kidney disease, or diarrhea. They must not be allergic to magnesium citrate or on certain pain meds like gabapentin.Check my eligibility
What is being tested?
The study tests whether Magnesium Citrate can be a safe and affordable alternative to current drugs for treating Restless Legs Syndrome. Participants will take this supplement to see if it improves their condition.See study design
What are the potential side effects?
While Magnesium Citrate is generally considered safe at the doses used in this study, potential side effects may include stomach upset or diarrhea. It's important that participants do not already have a tendency towards these conditions.
RLS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ completion of study participation at 8 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~completion of study participation at 8 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Correlation of magnesium levels with Kohnen Restless Legs Syndrome Quality of Life Instrument (KRLS) and Multiple Suggested Immobilization test (MSI) scores
Restless Legs Syndrome
Restless Legs Syndrome
+1 moreRLS Trial Design
1Treatment groups
Experimental Treatment
Group I: Magnesium CitrateExperimental Treatment1 Intervention
Magnesium Citrate given orally taken once daily for 8 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Magnesium Citrate
2016
N/A
~160
Find a Location
Who is running the clinical trial?
OSF Healthcare SystemLead Sponsor
29 Previous Clinical Trials
33,661 Total Patients Enrolled
Sasikanth Gorantla, MDPrincipal Investigator - OSF Healthcare Saint Francis Medical Center
OSF Healthcare System
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have severe heart problems with a weak heart, slow resting heart rate, and low blood pressure.You have diarrhea.You have a history of long-term kidney problems or are receiving hemodialysis for kidney failure.You have a known allergy to magnesium citrate.You are currently taking gabapentin or pregabalin for pain.Women who are pregnant or trying to get pregnant should not participate in the study.You are currently using magnesium supplements or have used them in the past 3 months.You are not taking a steady amount of certain medications that can cause or worsen certain sleep disorders.You are between 18 and 89 years old.You have not taken any restless leg syndrome medications for at least 1 year and do not have untreated obstructive sleep apnea.You have been diagnosed with Restless Legs Syndrome using specific criteria.This criterion refers to patients who are currently receiving care at the INI OSF Sleep Medicine outpatient clinic.
Research Study Groups:
This trial has the following groups:- Group 1: Magnesium Citrate
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Restless Legs Syndrome Patient Testimony for trial: Trial Name: NCT04462796 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who else is applying?
What state do they live in?
Indiana
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
1
Why did patients apply to this trial?
I've tried one drug that helps a bit, looking for a better outcome.
PatientReceived 2+ prior treatments
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