Magnesium Oxide Monohydrate for Nocturnal Leg Cramps

Quality of Life Clinical Trial

— MgNLC  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01709968
• Other study ID #: Com120009ctil
• Status: Terminated
• Phase: Phase 4
• First received: October 17, 2012
• Last updated: July 18, 2017
• Start date: February 2013
• Est. completion date: April 2014

Study information

• Verified date: July 2017
• Source: Clalit Health Services
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 94
• Est. completion date: April 2014
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Muscle Cramp
• Nocturnal Leg Cramps
• Quality of Life
• Spasm

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
• placebo
Similarly looking placebo. Oral administration once daily for 4 weeks

Locations

Country	Name	City	State
Israel	Clinical Research Unit, Clalit Health Services, Haifa and Western Galilee District,	Haifa,

Sponsors (1)

Lead Sponsor	Collaborator
Uzi Milman

Country where clinical trial is conducted

Israel, 

References & Publications (1)

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.20 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   pubmed/28241153