Magnesium Oxide Monohydrate for Nocturnal Leg Cramps
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.
Timeline
- Start
- 2013-02
- Primary completion
- 2013-10
- Completion
- 2014-04
Outcome
Missed primary endpoint
Stopped: “Blinded interim analysis Recommendation, submitted April 1, 2014, was early termination for futility.”
paper difference between groups of 0.38 (0.48) NLC per week (P = .67 in an intention-to-treat analysis). PMID 28241153 ↗
paper Oral magnesium oxide was not superior to placebo for older adults experiencing NLC. PMID 28241153 ↗
Publications
- Results 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | MAGNOX 520® | Unknown | 520 mg | Oral |
Indications
No indication recorded.