Magnesium Oxide Monohydrate for Nocturnal Leg Cramps (MgNLC)

Uzi Milman

Status and phase: Terminated; Phase 4

Conditions: Quality of Life; Nocturnal Leg Cramps

Treatments: Drug: placebo; Drug: MAGNOX 520®

Study type: Interventional

Funder types: Other

Identifiers

NCT01709968

Com120009ctil

Details and patient eligibility

About

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.

Full 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.

Enrollment: 94 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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94 participants in 2 patient groups, including a placebo group

MAGNOX 520®

Experimental group

Description:

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.

Treatment:

Drug: MAGNOX 520®

Similarly looking placebo.

Placebo Comparator group

Description:

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

Treatment:

Drug: placebo