Recruiting

Magnesium Citrate

Sponsor:

OSF Healthcare System

Code:

NCT04462796

Conditions

Restless Legs Syndrome

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Magnesium Citrate

Study Details

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, biologically plausible alternative to dopamine agonists and α2δ calcium-channel ligands.

Conditions

Restless Legs Syndrome

Study ID

NCT04462796

Start date

Jul 10, 2020

Status verified date

Feb, 2023

Completion date

Dec 31, 2023

Anticipated

Primary completion date

Dec 31, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion 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.

Exclusion Criteria:

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).

Study Design

Enrollment

15 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Magnesium Citrate

Magnesium Citrate given orally taken once daily for 8 weeks

Interventions

Magnesium Citrate

Magnesium Citrate 200 mg daily

Primary outcome measure

  • Subjective Improvement of Restless Legs Symptoms measured by the International Restless Legs Syndrome Scale (IRLS) [ Time Frame: Completion of Study participation at 8 weeks ]
  • Subjective Improvement of Restless Legs Symptoms measured by the Kohnen Kohnen Restless Legs Syndrome Quality of Life Instrument (KRLS QOL) [ Time Frame: Completion of Study participation at 8 weeks ]
  • Objective Improvement of Restless Legs Symptoms: Multiple Suggested Immobilization test (MSI) Score [ Time Frame: Completion of Study participation at 8 weeks ]
  • Correlation of magnesium levels with Kohnen Restless Legs Syndrome Quality of Life Instrument (KRLS) and Multiple Suggested Immobilization test (MSI) scores [ Time Frame: Completion of Study participation at 8 weeks ]

Central Contacts and Locations

Central contacts

Locations

OSF Healthcare Illinois Neurological Institute

Recruiting

Peoria, Illinois, United States, 61603

Contacts

More Information

Sponsor

OSF Healthcare System

Last update posted

Feb 17, 2023

Last verified

Feb, 2023

Keywords

  • RLS, Magnesium Citrate, Magnesium

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by OSF Healthcare System on 2023-02-17.