Magnesium Oxide Monohydrate for Nocturnal Leg Cramps (MgNLC)

• ClinicalTrials.gov Identifier: NCT01709968
• Recruitment Status: Terminated
• First Posted: October 18, 2012
• Last Update Posted: July 21, 2017
• Sponsor: Uzi Milman
• Information provided by (Responsible Party): Uzi Milman, Clalit Health Services

Tracking Information

• First Submitted Date: October 17, 2012
• First Posted Date: October 18, 2012
• Last Update Posted Date: July 21, 2017
• Study Start Date: February 2013
• Actual Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 17, 2012)

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;

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: October 17, 2012)

• 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;
• 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
• 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;
• 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;

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Magnesium Oxide Monohydrate for Nocturnal Leg Cramps
• Official Title: Magnesium Oxide Monohydrate for Nocturnal Leg Cramps (MgNLC); a Prospective, Randomized, Double Blind, Placebo Controlled Clinical Trial.
• 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.
• 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 Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment

Condition

• Nocturnal Leg Cramps
• Quality of Life

Intervention

• 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
• Drug: placebo
  Similarly looking placebo. Oral administration once daily for 4 weeks
  Other Name: Similarly looking placebo

Study Arms

• 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.
  Intervention: Drug: MAGNOX 520®
• Placebo Comparator: Similarly looking placebo.
  Similarly looking placebo. Oral administration once daily for 4 weeks.
  Intervention: Drug: placebo

Publications *

• Roguin Maor N, Alperin M, Shturman E, Khairaldeen H, Friedman M, Karkabi K, Milman U. Effect of Magnesium Oxide Supplementation on Nocturnal Leg Cramps: A Randomized Clinical Trial. JAMA Intern Med. 2017 May 1;177(5):617-623. doi: 10.1001/jamainternmed.2016.9261.
• Luo L, Zhou K, Zhang J, Xu L, Yin W. Interventions for leg cramps in pregnancy. Cochrane Database Syst Rev. 2020 Dec 4;12(12):CD010655. doi: 10.1002/14651858.CD010655.pub3.

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: April 10, 2014): 94
• Original Estimated Enrollment (submitted: October 17, 2012): 200
• Actual Study Completion Date: April 2014
• Actual Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 21 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Israel

Administrative Information

• NCT Number: NCT01709968
• Other Study ID Numbers: Com120009ctil
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Uzi Milman, Clalit Health Services
• Original Responsible Party: Same as current
• Current Study Sponsor: Uzi Milman
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• 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

• PRS Account: Clalit Health Services
• Verification Date: July 2017