TerminatedPhase 4

Magnesium Oxide Monohydrate for Nocturnal Leg Cramps

Stopped: Blinded interim analysis Recommendation, submitted April 1, 2014, was early termination for futility.

Israel94 participantsStarted 2013-02

Plain-language 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.

Who can participate

Age range21 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Number of documented episodes of NLC

Timeframe: 4 weeks

Trial details

NCT IDNCT01709968

SponsorUzi Milman

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2013-10