Magnesium Oxide Monohydrate for Nocturnal Leg Cramps (MgNLC)

This study has been terminated.
(Blinded interim analysis was presented to an independent data monitoring committee. Recommendation, submitted April 1, 2014, was early termination for futility.)
Sponsor:
Information provided by (Responsible Party):
Uzi Milman, Clalit Health Services
ClinicalTrials.gov Identifier:
NCT01709968
First received: October 17, 2012
Last updated: April 10, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Nocturnal Leg Cramps
Quality of Life
Drug: MAGNOX 520®
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Magnesium Oxide Monohydrate for Nocturnal Leg Cramps (MgNLC); a Prospective, Randomized, Double Blind, Placebo Controlled Clinical Trial.

Resource links provided by NLM:


Further study details as provided by Clalit Health Services:

Primary Outcome Measures:
  • Number of documented episodes of NLC [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    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;


Secondary Outcome Measures:
  • Severity of documented episodes of NLC [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    The difference in the severity 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;

  • Duration of documented episodes of NLC documented [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    The difference in the duration of episodes of NLC documented in the NCSD, as compared between the MAGNOX 520® and the placebo treated individuals, during a

  • Quality of life [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    The difference in the change in quality of life (measured by SF36 at enrolment and after the treatment period) between the MAGNOX 520® and the placebo treated individuals;

  • Quality of sleep [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    The difference in the change in quality of sleep (measured by PSQI at enrolment and after the treatment period) between the MAGNOX 520® and the placebo treated individuals;


Enrollment: 94
Study Start Date: February 2013
Study Completion Date: April 2014
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MAGNOX 520®
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®
Other Name: MAGNOX 520®
Placebo Comparator: Similarly looking placebo.
Similarly looking placebo. Oral administration once daily for 4 weeks.

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

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01709968

Locations
Israel
Clinical Research Unit, Clalit Health Services, Haifa and Western Galilee District,
Haifa,, Israel
Sponsors and Collaborators
Uzi Milman
Investigators
Principal Investigator: Noga Maor Rougin, MD Clinical Research Unit, Clalit Health Services, Haifa and Western Galilee District, HAIFA, ISRAEL
Study Director: Uzi Milman, MD Clinical Research Unit, Clalit Health Services, Haifa and Western Galilee District, HAIFA, ISRAEL
  More Information

No publications provided

Responsible Party: Uzi Milman, Director, Clinical Research Unit, Clalit Health Services, Haifa District, HAIFA, ISRAEL, Clalit Health Services
ClinicalTrials.gov Identifier: NCT01709968     History of Changes
Other Study ID Numbers: Com120009ctil
Study First Received: October 17, 2012
Last Updated: April 10, 2014
Health Authority: Israel: Ministry of Health

Keywords provided by Clalit Health Services:
Nocturnal Leg Cramps
Quality of life
Quality of sleep

Additional relevant MeSH terms:
Muscle Cramp
Sleep-Wake Transition Disorders
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Parasomnias
Sleep Disorders
Mental Disorders
Magnesium Oxide
Antacids
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014