NCT01709968

Magnesium Oxide Monohydrate for Nocturnal Leg Cramps

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

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 94 (actual)
• Sponsor: Uzi Milman · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Nocturnal Leg Cramps
• Quality of Life

Interventions

Type	Name	Description
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

Timeline

• Start date: 2013-02-01
• Primary completion: 2013-10-01
• Completion: 2014-04-01
• First posted: 2012-10-18
• Last updated: 2017-07-21

Locations

1 site across 1 country: Israel