Magnesium Oxide Monohydrate for Nocturnal Leg Cramps

NCT01709968 | Terminated Phase 4 DMC

• 1 other identifier: Com120009ctil
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

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.

Conditions

Nocturnal Leg Cramps; Quality of Life

Keywords

Nocturnal Leg Cramps; Quality of life; Quality of sleep

Outcome Measures

Primary Outcomes (1)

• Number of documented episodes of NLC

  The primary efficacy endpoint is the difference in the number of episodes of NLC documented in the NCSD, as compared between the MAGNOX 520® and the placebo treated individuals, during a treatment period of 4 weeks;

  4 weeks

Secondary Outcomes (4)

• Severity of documented episodes of NLC

  4 weeks

• Duration of documented episodes of NLC documented

  4 weeks

• Quality of life

  4 weeks

• Quality of sleep

  4 weeks

Study Arms (2)

MAGNOX 520®

EXPERIMENTAL

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.

Drug: MAGNOX 520®

Similarly looking placebo.

PLACEBO COMPARATOR

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

Drug: placebo

Interventions

MAGNOX 520® DRUG

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

MAGNOX 520®

placebo DRUG

Similarly looking placebo. Oral administration once daily for 4 weeks

Also known as: Similarly looking placebo

Similarly looking placebo.

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Uzi Milman: lead

Study Sites (1)

Clinical Research Unit, Clalit Health Services, Haifa and Western Galilee District,

Haifa, Israel

Location

Related Publications (2)

• 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.

  PMID: 28241153 RESULT

• 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.

  PMID: 33275278 DERIVED

Related Links

• pubmed/28241153

MeSH Terms

Conditions

Sleep-Wake Transition Disorders; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Parasomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias

Study Officials

• Noga Maor Rougin, MD

  Clinical Research Unit, Clalit Health Services, Haifa and Western Galilee District, HAIFA, ISRAEL

  PRINCIPAL INVESTIGATOR

• Uzi Milman, MD

  Clinical Research Unit, Clalit Health Services, Haifa and Western Galilee District, HAIFA, ISRAEL

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, Clinical Research Unit, Clalit Health Services, Haifa District, HAIFA, ISRAEL

Study Record Dates

• First Submitted: October 17, 2012
• First Posted: October 18, 2012
• Study Start: February 1, 2013
• Primary Completion: October 1, 2013
• Study Completion: April 1, 2014
• Last Updated: July 21, 2017

Record last verified: 2017-07

Locations

IL (1)