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

Primary Purpose

Restless Legs Syndrome

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Magnesium Citrate

About this trial

This is an interventional other trial for Restless Legs Syndrome focused on measuring RLS, Magnesium Citrate, Magnesium

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 Criteria:

Patients who are currently taking magnesium supplements or took magnesium supplements in 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 include antidepressants such as SSRIs, SNRIs and TCAs and Antihistamines such as Benadryl and Allegra, etc)
Patients with a history of chronic kidney disease or end-stage renal disease on Hemodialysis
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 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).

Sites / Locations

OSF Healthcare Illinois Neurological InstituteRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Magnesium Citrate

Arm Description

Magnesium Citrate given orally taken once daily for 8 weeks

Outcomes

Primary Outcome Measures

Subjective Improvement of Restless Legs Symptoms measured by the International Restless Legs Syndrome Scale (IRLS)

International Restless Leg Syndrome Scale. (IRLS) is a 10 question scale that subjects rate on a scale of 0-4; RLS can be classified as mild, moderate, severe and very severe, if the score is 0-10 (mild), 11-20 (moderate), 21-30 (severe) or 31-40 (very severe) respectively. The lower score reflects less symptom burden. Minimum score is 0 with a Maximum of 40.

Subjective Improvement of Restless Legs Symptoms measured by the Kohnen Kohnen Restless Legs Syndrome Quality of Life Instrument (KRLS QOL)

Kohnen Restless Legs Syndrome Quality of Life instrument (KRLS QOL) is a self-administered validated patient-reported outcome measure with 12 questions that assess the quality of life in RLS patients. Scores range from 0-60.The lower score represents less impact of RLS symptoms on quality of life.

Objective Improvement of Restless Legs Symptoms: Multiple Suggested Immobilization test (MSI) Score

Reduction in Multiple Suggested Immobilization test (MSI) discomfort Scores, range: 0-10, with a maximum total sum of 60 per hour. Three 1 hour trials will be conducted. Periodic limb movements during wakefulness will also be measured. Periodic limb movement index (PMLI) reflects periodic limb movements per hour. PMLI value of 0 indicates absence of limb movements and higher scores are often seen in patients with severe RLS

Correlation of magnesium levels with Kohnen Restless Legs Syndrome Quality of Life Instrument (KRLS) and Multiple Suggested Immobilization test (MSI) scores

Assessment of Magnesium level, lab value will be assess. Normal values range from 1.6 - 2.6 mg/dl. The rationale of measuring serum magnesium level is to analyze whether serum magnesium levels correlate with other subjective and objective RLS outcome measures

Secondary Outcome Measures

Full Information

NCT ID

NCT04462796

First Posted

July 5, 2020

Last Updated

February 15, 2023

Sponsor

OSF Healthcare System

1. Study Identification

Unique Protocol Identification Number

NCT04462796

Brief Title

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

Acronym

RLS

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Recruiting

Study Start Date

July 10, 2020 (Actual)

Primary Completion Date

December 31, 2023 (Anticipated)

Study Completion Date

December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

OSF Healthcare System

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Restless Legs Syndrome

Keywords

RLS, Magnesium Citrate, Magnesium

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Pilot study

Masking

None (Open Label)

Allocation

N/A

Enrollment

15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Magnesium Citrate

Arm Type

Experimental

Arm Description

Magnesium Citrate given orally taken once daily for 8 weeks

Intervention Type

Dietary Supplement

Intervention Name(s)

Magnesium Citrate

Intervention Description

Magnesium Citrate 200 mg daily

Primary Outcome Measure Information:

Title

Subjective Improvement of Restless Legs Symptoms measured by the International Restless Legs Syndrome Scale (IRLS)

Description

Time Frame

Completion of Study participation at 8 weeks

Title

Subjective Improvement of Restless Legs Symptoms measured by the Kohnen Kohnen Restless Legs Syndrome Quality of Life Instrument (KRLS QOL)

Description

Time Frame

Completion of Study participation at 8 weeks

Title

Objective Improvement of Restless Legs Symptoms: Multiple Suggested Immobilization test (MSI) Score

Description

Time Frame

Completion of Study participation at 8 weeks

Title

Correlation of magnesium levels with Kohnen Restless Legs Syndrome Quality of Life Instrument (KRLS) and Multiple Suggested Immobilization test (MSI) scores

Description

Time Frame

Completion of Study participation at 8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

89 Years

Accepts Healthy Volunteers

Eligibility Criteria

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 Criteria: Patients who are currently taking magnesium supplements or took magnesium supplements in 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 include antidepressants such as SSRIs, SNRIs and TCAs and Antihistamines such as Benadryl and Allegra, etc) Patients with a history of chronic kidney disease or end-stage renal disease on Hemodialysis 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 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).

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ashwath R Ravisankar, MBBS

Phone

(309) 624-5422

ashwath.r.ravisankar@osfhealthcare.org

First Name & Middle Initial & Last Name or Official Title & Degree

Kimberly L Hartwig, RN, BSN

Phone

(309) 655-4229

kimberly.hartwig@osfhealthcare.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sasikanth Gorantla, MD

Organizational Affiliation

OSF Healthcare Saint Francis Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

OSF Healthcare Illinois Neurological Institute

City

Peoria

State/Province

Illinois

ZIP/Postal Code

61603

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Praneeth K Chebrolu, MBBS

Phone

309-624-5419

praneeth.k.chebrolu@osfhealthcare.org

12. IPD Sharing Statement

Plan to Share IPD

Undecided

IPD Sharing Plan Description

Plan to share an abstract and data analysis results.

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Links:

URL

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

Description

Manual used for scoring sleep and associated events

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

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