RECRUITING

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

Conditions

Restless Legs Syndrome RLS, Magnesium Citrate, Magnesium

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2020-07-10

Study Completion:2023-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04462796

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.

Ages Eligible for Study:18 Years to 89 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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).

Inclusion Criteria

Exclusion 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).

Contacts and Locations

Study Contact

Ashwath R Ravisankar, MBBS

CONTACT

(309) 624-5422

ashwath.r.ravisankar@osfhealthcare.org

Kimberly L Hartwig, RN, BSN

CONTACT

(309) 655-4229

kimberly.hartwig@osfhealthcare.org

Principal Investigator

Sasikanth Gorantla, MD

PRINCIPAL_INVESTIGATOR

OSF Healthcare Saint Francis Medical Center

Study Locations (Sites)

OSF Healthcare Illinois Neurological Institute

Peoria, Illinois, 61603

United States

Collaborators and Investigators

Sponsor: OSF Healthcare System

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-07-10

Study Completion Date2023-12-31

Study Record Updates

Study Start Date2020-07-10

Study Completion Date2023-12-31

Terms related to this study

Keywords Provided by Researchers

RLS, Magnesium Citrate, Magnesium

Additional Relevant MeSH Terms

Restless Legs Syndrome