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

NCT04462796 | Unknown

• 1 other identifier: 1567451
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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

Keywords

RLS, Magnesium Citrate, Magnesium

Outcome Measures

Primary Outcomes (4)

• 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.

  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)

  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.

  Completion of Study participation at 8 weeks

• 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

  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

  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

  Completion of Study participation at 8 weeks

Study Arms (1)

Magnesium Citrate

EXPERIMENTAL

Magnesium Citrate given orally taken once daily for 8 weeks

Dietary Supplement: Magnesium Citrate

Interventions

Magnesium Citrate DIETARY_SUPPLEMENT

Magnesium Citrate 200 mg daily

Magnesium Citrate

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• OSF Healthcare System: lead

Study Sites (1)

OSF Healthcare Illinois Neurological Institute

Peoria, Illinois, 61603, United States

RECRUITING

Related Publications (24)

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• Garcia-Borreguero D, Guitart X, Garcia Malo C, Cano-Pumarega I, Granizo JJ, Ferre S. Treatment of restless legs syndrome/Willis-Ekbom disease with the non-selective ENT1/ENT2 inhibitor dipyridamole: testing the adenosine hypothesis. Sleep Med. 2018 May;45:94-97. doi: 10.1016/j.sleep.2018.02.002. Epub 2018 Feb 24.

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• Leu-Semenescu S, Petiau C, Charley Monaca C, Dauvilliers Y. French consensus: Augmentation syndrome in restless legs syndrome. Rev Neurol (Paris). 2018 Sep-Oct;174(7-8):532-539. doi: 10.1016/j.neurol.2018.06.004. Epub 2018 Jul 25.

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• Ito E, Inoue Y. [The International Classification of Sleep Disorders, third edition. American Academy of Sleep Medicine. Includes bibliographies and index]. Nihon Rinsho. 2015 Jun;73(6):916-23. Japanese.

  PMID: 26065120 BACKGROUND

• Ferini-Strambi L, Aarskog D, Partinen M, Chaudhuri KR, Sohr M, Verri D, Albrecht S. Effect of pramipexole on RLS symptoms and sleep: a randomized, double-blind, placebo-controlled trial. Sleep Med. 2008 Dec;9(8):874-81. doi: 10.1016/j.sleep.2008.09.001. Epub 2008 Oct 25.

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  PMID: 23938061 BACKGROUND

• Walters AS, LeBrocq C, Dhar A, Hening W, Rosen R, Allen RP, Trenkwalder C; International Restless Legs Syndrome Study Group. Validation of the International Restless Legs Syndrome Study Group rating scale for restless legs syndrome. Sleep Med. 2003 Mar;4(2):121-32. doi: 10.1016/s1389-9457(02)00258-7.

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  PMID: 16713344 BACKGROUND

• Kohnen R, Martinez-Martin P, Benes H, Trenkwalder C, Hogl B, Dunkl E, Walters AS. Validation of the Kohnen Restless Legs Syndrome-Quality of Life instrument. Sleep Med. 2016 Aug;24:10-17. doi: 10.1016/j.sleep.2016.04.019. Epub 2016 Aug 3.

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• Sforza E, Johannes M, Claudio B. The PAM-RL ambulatory device for detection of periodic leg movements: a validation study. Sleep Med. 2005 Sep;6(5):407-13. doi: 10.1016/j.sleep.2005.01.004. Epub 2005 Apr 1.

  PMID: 16139771 BACKGROUND

• Garcia-Borreguero D, Kohnen R, Boothby L, Tzonova D, Larrosa O, Dunkl E. Validation of the Multiple Suggested Immobilization Test: A Test for the Assessment of Severity of Restless Legs Syndrome (Willis-Ekbom Disease). Sleep. 2013 Jul 1;36(7):1101-1109. doi: 10.5665/sleep.2820.

  PMID: 23814348 BACKGROUND

• De Cock VC, Bayard S, Yu H, Grini M, Carlander B, Postuma R, Charif M, Dauvilliers Y. Suggested immobilization test for diagnosis of restless legs syndrome in Parkinson's disease. Mov Disord. 2012 May;27(6):743-9. doi: 10.1002/mds.24969. Epub 2012 Mar 21.

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• Gorantla S, Ravisankar A, Trotti LM. Magnesium citrate monotherapy improves restless legs syndrome symptoms and multiple suggested immobilization test scores in an open-label pilot study. J Clin Sleep Med. 2024 Aug 1;20(8):1357-1361. doi: 10.5664/jcsm.11206.

  PMID: 38738598 DERIVED

Related Links

• Manual used for scoring sleep and associated events

MeSH Terms

Conditions

Restless Legs Syndrome

Interventions

magnesium citrate

Condition Hierarchy (Ancestors)

Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Parasomnias; Mental Disorders

Study Officials

• Sasikanth Gorantla, MD

  OSF Healthcare Saint Francis Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Pilot study

Study Record Dates

• First Submitted: July 5, 2020
• First Posted: July 8, 2020
• Study Start: July 10, 2020
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: February 17, 2023

Record last verified: 2023-02

Locations

US (1)