Magnesium Oxide Monohydrate for Nocturnal Leg Cramps

Study Overview
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Brief Summary
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Nocturnal leg cramps (NLC) are painful, involuntary contractions of muscles occurring at rest, mostly at night. A Cochrane review on leg cramps in pregnancy showed some potential benefits in trials of magnesium. This is a single center, prospective, randomized, double blind, placebo controlled clinical trial that aims to investigate the effect of treatment with Magnox 520® (un-organic granular magnesium complex, composed of Magnesium Oxide & Magnesium Oxide Monohydrate 865mg, Provides 520 mg of free elemental Mg++) on frequency and severity of NLC, quality of sleep and quality of life. Hypothesis: Magnox 520® may reduce the number and severity of NLC; an improvement in the quality of life and quality of sleep may ensue.

Detailed Description
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Ads in the local media and pharmacies will invite individuals afflicted by NLC to participate in the study. Each participating individual will undergo two weeks of eligibility screening followed by 4-week double-blind treatment. The number, severity and duration of NLC will be measured daily as documented in a designated, structured sleep dairy. Quality of life and quality of sleep will be assessed by SF-36 and PSQI questionnaires, respectively, to be completed twice - at enrollment and within one week of the end of the treatment period.

Official Title
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Magnesium Oxide Monohydrate for Nocturnal Leg Cramps (MgNLC); a Prospective, Randomized, Double Blind, Placebo Controlled Clinical Trial.

Conditions
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Nocturnal Leg Cramps, Quality of Life

Intervention / Treatment
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* Drug: MAGNOX 520®
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed informed consent before any procedure or assessment is done. Age over 21 years old. Over 4 episodes of documented NLC during 2 weeks of eligibility screening (for the treatment phase). Insured by Clalit Health Services (CHS). Hebrew speaking Exclusion Criteria: Pregnancy Currently taking Quinidine or Magnesium additive Renal failure - serum creatinine more than 2 mg/DL or estimated glomerular filtration rate (eGFR) less than 60 ml/min (the worst, ascertained by the participant electronic records in the last 6 months). If the result is near these limits (i.e. serum creatinin 1.5-2) a second analysis will be done near the study enrollment. Major neurological disease- ALS, MS, Paraplegia or Quadriplegia.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MAGNOX 520®<br>MAGNOX 520® (un-organic granular magnesium complex, composed of Magnesium Oxide & Magnesium Oxide Monohydrate 865mg, Provides 520 mg of free elemental Mg ++); Oral administration once daily for 4 weeks. | Drug: MAGNOX 520®<br>* un-organic granular magnesium complex, composed of Magnesium Oxide & Magnesium Oxide Monohydrate 865mg, Provides 520 mg of free elemental Mg ++); Oral administration once daily for 4 weeks<br>|
| Placebo Comparator: Similarly looking placebo.<br>Similarly looking placebo. Oral administration once daily for 4 weeks. | Drug: placebo<br>* Similarly looking placebo. Oral administration once daily for 4 weeks<br>* Other names: Similarly looking placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of documented episodes of NLC | The primary efficacy endpoint is the difference in the number of episodes of NLC documented in the NCSD, as compared between the MAGNOX 520® and the placebo treated individuals, during a treatment period of 4 weeks; | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of documented episodes of NLC | The difference in the severity of episodes of NLC documented in the NCSD, as compared between the MAGNOX 520® and the placebo treated individuals, during a treatment period of 4 weeks; | 4 weeks | 
| Duration of documented episodes of NLC documented | The difference in the duration of episodes of NLC documented in the NCSD, as compared between the MAGNOX 520® and the placebo treated individuals, during a | 4 weeks | 
| Quality of life | The difference in the change in quality of life (measured by SF36 at enrolment and after the treatment period) between the MAGNOX 520® and the placebo treated individuals; | 4 weeks | 
| Quality of sleep | The difference in the change in quality of sleep (measured by PSQI at enrolment and after the treatment period) between the MAGNOX 520® and the placebo treated individuals; | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nocturnal Leg Cramps, Quality of life, Quality of sleep