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Magnesium Oxide Monohydrate for Nocturnal Leg Cramps (MgNLC)

Primary Purpose

Nocturnal Leg Cramps, Quality of Life

Status

Terminated

Phase

Phase 4

Locations

Israel

Study Type

Interventional

Intervention

MAGNOX 520®

placebo

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

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arm Type

Experimental

Placebo Comparator

Arm Label

MAGNOX 520®

Similarly looking placebo.

Arm Description

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.

Outcomes

Primary Outcome Measures

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;

Secondary Outcome Measures

Severity of documented episodes of NLC

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

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

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

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;

Full Information

NCT ID

NCT01709968

First Posted

October 17, 2012

Last Updated

July 18, 2017

Sponsor

Uzi Milman

1. Study Identification

Unique Protocol Identification Number

NCT01709968

Brief Title

Magnesium Oxide Monohydrate for Nocturnal Leg Cramps

Acronym

MgNLC

Official Title

Magnesium Oxide Monohydrate for Nocturnal Leg Cramps (MgNLC); a Prospective, Randomized, Double Blind, Placebo Controlled Clinical Trial.

Study Type

Interventional

2. Study Status

Record Verification Date

July 2017

Overall Recruitment Status

Terminated

Why Stopped

Blinded interim analysis Recommendation, submitted April 1, 2014, was early termination for futility.

Study Start Date

February 2013 (undefined)

Primary Completion Date

October 2013 (Actual)

Study Completion Date

April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Uzi Milman

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Nocturnal Leg Cramps, Quality of Life

Keywords

Nocturnal Leg Cramps, Quality of life, Quality of sleep

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

94 (Actual)

8. Arms, Groups, and Interventions

Arm Title

MAGNOX 520®

Arm Type

Experimental

Arm Description

Arm Title

Similarly looking placebo.

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

MAGNOX 520®

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

placebo

Other Intervention Name(s)

Similarly looking placebo

Intervention Description

Similarly looking placebo. Oral administration once daily for 4 weeks

Primary Outcome Measure Information:

Title

Number of documented episodes of NLC

Description

Time Frame

4 weeks

Secondary Outcome Measure Information:

Title

Severity of documented episodes of NLC

Description

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;

Time Frame

4 weeks

Title

Duration of documented episodes of NLC documented

Description

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

Time Frame

4 weeks

Title

Quality of life

Description

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;

Time Frame

4 weeks

Title

Quality of sleep

Description

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;

Time Frame

4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Noga Maor Rougin, MD

Organizational Affiliation

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

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Uzi Milman, MD

Organizational Affiliation

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

Official's Role

Study Director

Facility Information:

Facility Name

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

City

Haifa,

Country

Israel

12. IPD Sharing Statement

Citations:

PubMed Identifier

28241153

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.

Results Reference

result

PubMed Identifier

33275278

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.

Results Reference

derived

Links:

URL

https://www.ncbi.nlm.nih.gov/pubmed/28241153

Description

pubmed/28241153

Learn more about this trial

Magnesium Oxide Monohydrate for Nocturnal Leg Cramps

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