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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04462796
Recruitment Status : Recruiting
First Posted : July 8, 2020
Last Update Posted : June 11, 2021
Sponsor:
Information provided by (Responsible Party):
Sasikanth Gorantla, OSF Healthcare System

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.

Condition or disease Intervention/treatment Phase
Restless Legs Syndrome Dietary Supplement: Magnesium Citrate Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Pilot study
Masking: None (Open Label)
Primary Purpose: Other
Official Title: The Effect of Magnesium Citrate Supplementation in Patients With Restless Legs Syndrome (RLS) - An Open Label, Prospective, Non Placebo Controlled Pilot Study
Actual Study Start Date : July 10, 2020
Estimated Primary Completion Date : February 2022
Estimated Study Completion Date : April 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Restless Legs

Arm Intervention/treatment
Experimental: Magnesium Citrate
Magnesium Citrate given orally taken once daily for 8 weeks
Dietary Supplement: Magnesium Citrate
Magnesium Citrate 200 mg daily




Primary Outcome Measures :
  1. Subjective Improvement of Restless Legs Symptoms measured by the International Restless Legs Syndrome Scale (IRLS) [ Time Frame: Completion of Study participation at 8 weeks ]
    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.

  2. 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 ]
    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.

  3. Objective Improvement of Restless Legs Symptoms: Multiple Suggested Immobilization test (MSI) Score [ Time Frame: Completion of Study participation at 8 weeks ]
    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

  4. 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 ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04462796


Contacts
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Contact: Mandi L Arnold, RN, BSN (309) 624-4087 mandi.l.arnold@osfhealthcare.org
Contact: Kimberly L Hartwig, RN, BSN (309) 655-4229 kimberly.hartwig@osfhealthcare.org

Locations
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United States, Illinois
OSF Healthcare Illinois Neurological Institute Recruiting
Peoria, Illinois, United States, 61603
Contact: Sara J Riggenbach, BS    309-624-5419    sara.j.riggenbach@osfhealthcare.org   
Sponsors and Collaborators
OSF Healthcare System
Investigators
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Principal Investigator: Sasikanth Gorantla, MD OSF Healthcare Saint Francis Medical Center
Additional Information:
Publications:

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Responsible Party: Sasikanth Gorantla, Principal Investigator, OSF Healthcare System
ClinicalTrials.gov Identifier: NCT04462796    
Other Study ID Numbers: 1567451
First Posted: July 8, 2020    Key Record Dates
Last Update Posted: June 11, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Plan to share an abstract and data analysis results.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sasikanth Gorantla, OSF Healthcare System:
RLS, Magnesium Citrate, Magnesium
Additional relevant MeSH terms:
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Psychomotor Agitation
Restless Legs Syndrome
Syndrome
Disease
Pathologic Processes
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Parasomnias
Mental Disorders
Magnesium citrate
Cathartics
Gastrointestinal Agents