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Magnesium Oxide Monohydrate for Nocturnal Leg Cramps (MgNLC)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01709968
Recruitment Status : Terminated (Blinded interim analysis Recommendation, submitted April 1, 2014, was early termination for futility.)
First Posted : October 18, 2012
Last Update Posted : July 21, 2017
Sponsor:
Information provided by (Responsible Party):
Uzi Milman, Clalit Health Services

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Nocturnal Leg Cramps Quality of Life Drug: MAGNOX 520® Drug: placebo Phase 4

Detailed Description:
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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 94 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Magnesium Oxide Monohydrate for Nocturnal Leg Cramps (MgNLC); a Prospective, Randomized, Double Blind, Placebo Controlled Clinical Trial.
Study Start Date : February 2013
Actual Primary Completion Date : October 2013
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Muscle Cramps

Arms and Interventions
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Arm Intervention/treatment
Experimental: MAGNOX 520®
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®
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
Placebo Comparator: Similarly looking placebo.
Similarly looking placebo. Oral administration once daily for 4 weeks.
 Drug: placebo
Similarly looking placebo. Oral administration once daily for 4 weeks
Other Name: Similarly looking placebo


Outcome Measures
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Primary Outcome Measures :
  1. Number of documented episodes of NLC [ Time Frame: 4 weeks ]
    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;


Secondary Outcome Measures :
  1. Severity of documented episodes of NLC [ Time Frame: 4 weeks ]
    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;

  2. Duration of documented episodes of NLC documented [ Time Frame: 4 weeks ]
    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

  3. Quality of life [ Time Frame: 4 weeks ]
    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. Quality of sleep [ Time Frame: 4 weeks ]
    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;


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Contacts and Locations
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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): NCT01709968


Locations
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Israel
Clinical Research Unit, Clalit Health Services, Haifa and Western Galilee District,
Haifa,, Israel
Sponsors and Collaborators
Uzi Milman
Investigators
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Principal Investigator: Noga Maor Rougin, MD Clinical Research Unit, Clalit Health Services, Haifa and Western Galilee District, HAIFA, ISRAEL
Study Director: Uzi Milman, MD Clinical Research Unit, Clalit Health Services, Haifa and Western Galilee District, HAIFA, ISRAEL
More Information
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Additional Information:

Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Uzi Milman, Director, Clinical Research Unit, Clalit Health Services, Haifa District, HAIFA, ISRAEL, Clalit Health Services
ClinicalTrials.gov Identifier: NCT01709968    
Other Study ID Numbers: Com120009ctil
First Posted: October 18, 2012    Key Record Dates
Last Update Posted: July 21, 2017
Last Verified: July 2017
Keywords provided by Uzi Milman, Clalit Health Services:
Nocturnal Leg Cramps
Quality of life
Quality of sleep
Additional relevant MeSH terms:
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Muscle Cramp
Spasm
Sleep-Wake Transition Disorders
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
 Neurologic Manifestations
Nervous System Diseases
Parasomnias
Sleep Wake Disorders
Mental Disorders