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

NCT ID: NCT04462796

Last Updated: 2023-02-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-10
• Study Completion Date: 2023-12-31

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.

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 Francis Medical Center sleep center and Illinois Neurological Institute. RLS/WED patients who meet inclusion and exclusion criteria during the initial clinic visit will be offered study participation. Standard treatment options will be discussed prior to the enrollment. Patients will be reassured that not participating in the study will not affect the future care they receive at OSF HealthCare. The potential risks and benefits of the study will be provided and, if the patient is interested, informed consent will be obtained. If the subject withdraws consent or does not finish both pre and post evaluation, we will replace the subject with another new recruit. The subject will come to the clinic for 2 visits, a pre-magnesium visit and a post-magnesium visit. Following the completion of the pre-magnesium visit, the subject will be given 200 mg elemental magnesium daily (will be instructed to take with food at dinner) for 8 weeks. Both Visits the following study procedures will be performed: magnesium level, (International Restless Legs Syndrome) IRLS scale, Kohnen Restless Legs Syndrome Quality of Life Instrument (KRLS-QOL) scale and (Multiple Suggested Immobilization (MSI) test. The post magnesium visit will be schedule at the completion of the 8 week dose of magnesium.

Conditions

Restless Legs Syndrome

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Magnesium Citrate

Magnesium Citrate given orally taken once daily for 8 weeks

Group Type: EXPERIMENTAL

Magnesium Citrate

Intervention Type: DIETARY_SUPPLEMENT

Magnesium Citrate 200 mg daily

Interventions

Magnesium Citrate

Magnesium Citrate 200 mg daily

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

OSF Healthcare System

OTHER

Sponsor Role: lead

Responsible Party

Sasikanth Gorantla

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sasikanth Gorantla, MD

Role: PRINCIPAL_INVESTIGATOR

OSF Healthcare Saint Francis Medical Center

Locations

OSF Healthcare Illinois Neurological Institute

Peoria, Illinois, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Ashwath R Ravisankar, MBBS

Role: CONTACT

ashwath.r.ravisankar@osfhealthcare.org

(309) 624-5422

Kimberly L Hartwig, RN, BSN

Role: CONTACT

kimberly.hartwig@osfhealthcare.org

(309) 655-4229

Facility Contacts

Praneeth K Chebrolu, MBBS

Role: primary

praneeth.k.chebrolu@osfhealthcare.org

309-624-5419

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Related Links

https://aasm.org/clinical-resources/scoring-manual/

Manual used for scoring sleep and associated events

Other Identifiers

1567451

Identifier Type: -

Identifier Source: org_study_id