Clinical trial NCT01709968: Magnesium Oxide Monohydrate for Nocturnal Leg Cramps
Official title: Magnesium Oxide Monohydrate for Nocturnal Leg Cramps (MgNLC); a Prospective, Randomized, Double Blind, Placebo Controlled Clinical Trial.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Nocturnal Leg Cramps
Quality of Life
Keywords: Nocturnal Leg Cramps
Quality of life
Quality of sleep
Lead sponsor: Clalit Health Services
Sponsor class: OTHER
First posted: 2012-10-18
Enrollment: 94
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Primary outcomes:
measure: Number of documented episodes of NLC
timeFrame: 4 weeks
Secondary outcomes:
measure: Severity of documented episodes of NLC
timeFrame: 4 weeks
measure: Duration of documented episodes of NLC documented
timeFrame: 4 weeks
measure: Quality of life
timeFrame: 4 weeks
measure: Quality of sleep
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Haifa,
country: Israel
facility: Clinical Research Unit, Clalit Health Services, Haifa and Western Galilee District,
Study officials:
affiliation: Clinical Research Unit, Clalit Health Services, Haifa and Western Galilee District, HAIFA, ISRAEL
name: Noga Maor Rougin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinical Research Unit, Clalit Health Services, Haifa and Western Galilee District, HAIFA, ISRAEL
name: Uzi Milman, MD
role: STUDY_DIRECTOR
References:
citation: 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.2016.9261.
citation: Luo L, Zhou K, Zhang J, Xu L, Yin W. Interventions for leg cramps in pregnancy. Cochrane Database Syst Rev. 2020 Dec 4;12(12):CD010655. doi: 10.1002/14651858.CD010655.pub3.