Magnesium Oxide Monohydrate for Nocturnal Leg Cramps (MgNLC)
Nocturnal Leg Cramps, Quality of Life
About this trial
This is an interventional treatment trial for Nocturnal Leg Cramps focused on measuring Nocturnal Leg Cramps, Quality of life, Quality of sleep
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.
Sites / Locations
- Clinical Research Unit, Clalit Health Services, Haifa and Western Galilee District,
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
MAGNOX 520®
Similarly looking placebo.
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.
Similarly looking placebo. Oral administration once daily for 4 weeks.