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Topical Magnesium and Muscle Cramps in Dialysis Patients.

Primary Purpose

Chronic Kidney Diseases, End Stage Renal Disease, Dialysis Related Complications

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Transdermal Magnesium
Placebo
Sponsored by
Sir Charles Gairdner Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Diseases

Eligibility Criteria

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

Inclusion Criteria:

  • Diagnosis of chronic kidney disease and receiving dialysis treatment
  • Previous experience of at least 2 or more muscle cramps per month in at least 3 of the last 6 months
  • Men or women aged 18 years and older
  • Capacity to provide informed consent

Exclusion Criteria:

  • Patients less than 18 years of age
  • Women who are pregnant and the human fetus
  • Serious, uncontrolled disease (including serious psychological disorders) likely to interfere with the study and/or likely to cause death within the study duration
  • Participation in another clinical during the last 12 weeks
  • Known allergic reactions against any component of the study drug or its comparator(s)
  • Known contraindication to any component of the study drug or its comparator(s)
  • Concurrent diseases which exclude the administration of therapy as outlined by the study protocol
  • Subjects who, in the opinion of the investigator, are not likely to complete the study for whatever reason.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Transdermal Magnesium

    Placebo

    Arm Description

    5 sprays each on the 2 most effected areas for muscle cramps twice a day

    5 sprays each on the 2 most effected areas for muscle cramps twice a day

    Outcomes

    Primary Outcome Measures

    Difference in the average number of muscle cramps per week between magnesium and placebo treatments
    final 3 weeks

    Secondary Outcome Measures

    Difference in average cramp duration between magnesium and placebo treatments
    final 3 weeks
    Difference in average cramp severity between magnesium and placebo treatments
    final 3 weeks
    Percentage change in serum magnesium concentration from baseline and at the end of each treatment stage
    Difference in restless legs symptoms between the magnesium and placebo treatment stages.

    Full Information

    First Posted
    March 13, 2017
    Last Updated
    March 16, 2017
    Sponsor
    Sir Charles Gairdner Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03082625
    Brief Title
    Topical Magnesium and Muscle Cramps in Dialysis Patients.
    Official Title
    Topical Magnesium Supplementation for the Treatment of Muscle Cramps in Dialysis Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    May 1, 2017 (Anticipated)
    Primary Completion Date
    March 31, 2018 (Anticipated)
    Study Completion Date
    December 31, 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Sir Charles Gairdner Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Oral magnesium supplementation has been widely used in the treatment of muscle cramps. Muscle cramps are common in dialysis patients but are not satisfactorily prevented by oral magnesium. Transdermal administration of magnesium has been promoted as a potential treatment for muscle cramps but this has not been investigated rigorously. We aim to evaluate the effectiveness of transdermal magnesium supplementation in reducing cramp frequency and severity. We will recruit current haemodialysis patients who suffer from muscle cramps into a randomised, placebo-controlled, cross-over design trial. Each intervention period will last 8 weeks with a 4-week washout period in between. We will measure muscle cramp frequency, duration and severity as the primary outcomes.
    Detailed Description
    Study participants will be provided with a cramp diary in which they will record the date, time, duration and severity of any muscle cramps they experience. Severity will be measured using a Likert scale in which participants will be asked to mark along a 10 cm line the severity of the pain they have experienced with each muscle cramp (ranging from no pain to the worst pain possible). The distance between "no pain" and the participant's mark will then be measured in centimetres (to one decimal point) to provide a precise value for muscle cramp severity. Participants will also be asked to record the duration of each muscle cramp they experience to the nearest minute. Patients will be asked to record in their cramp diaries the nature of any unwanted skin changes they may have experienced during their participation in the study including when they first noticed these changes and the duration in which they were affected by them. Serum magnesium, calcium and potassium levels will be measured and recorded before commencement of the study, at the end of the first stage of the study, at the end of the washout out period and at the end of the second stage of the study. Patients will also be asked to describe their restless leg symptoms at different periods of the study from - no different to usual, better, much better, worse, much worse. Participants will be seen by the investigators at enrolment into the study and at the end of the run-in period, first treatment period and second treatment period. In addition, participants will be asked to fill in a Likert scale regarding their views on how effective they believe the treatments were after each treatment period. 5.2 Study Plan During the run-in period patients will make no changes to their treatments for their muscle cramps. During the treatment periods patients will be asked to apply five sprays of the intervention or placebo to the two sites of the body most commonly affected by muscle cramps, twice daily. During the two-week wash-out period there will be no spray applied.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Kidney Diseases, End Stage Renal Disease, Dialysis Related Complications

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Model Description
    Randomised placebo-controlled
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Masking Description
    Identical delivery systems and appearance of the product
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Transdermal Magnesium
    Arm Type
    Experimental
    Arm Description
    5 sprays each on the 2 most effected areas for muscle cramps twice a day
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    5 sprays each on the 2 most effected areas for muscle cramps twice a day
    Intervention Type
    Drug
    Intervention Name(s)
    Transdermal Magnesium
    Other Intervention Name(s)
    Topical Magnesium
    Intervention Description
    Magnesium
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Primary Outcome Measure Information:
    Title
    Difference in the average number of muscle cramps per week between magnesium and placebo treatments
    Description
    final 3 weeks
    Time Frame
    3 weeks
    Secondary Outcome Measure Information:
    Title
    Difference in average cramp duration between magnesium and placebo treatments
    Description
    final 3 weeks
    Time Frame
    3 weeks
    Title
    Difference in average cramp severity between magnesium and placebo treatments
    Description
    final 3 weeks
    Time Frame
    3 weeks
    Title
    Percentage change in serum magnesium concentration from baseline and at the end of each treatment stage
    Time Frame
    3 weeks
    Title
    Difference in restless legs symptoms between the magnesium and placebo treatment stages.
    Time Frame
    3 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Diagnosis of chronic kidney disease and receiving dialysis treatment Previous experience of at least 2 or more muscle cramps per month in at least 3 of the last 6 months Men or women aged 18 years and older Capacity to provide informed consent Exclusion Criteria: Patients less than 18 years of age Women who are pregnant and the human fetus Serious, uncontrolled disease (including serious psychological disorders) likely to interfere with the study and/or likely to cause death within the study duration Participation in another clinical during the last 12 weeks Known allergic reactions against any component of the study drug or its comparator(s) Known contraindication to any component of the study drug or its comparator(s) Concurrent diseases which exclude the administration of therapy as outlined by the study protocol Subjects who, in the opinion of the investigator, are not likely to complete the study for whatever reason.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Neil C Boudville, MBBS MMedSci
    Phone
    61-8-6457-3333
    Email
    neil.boudville@uwa.edu.au

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    IPD Sharing Plan Description
    The plan at this stage is to have unidentified information available in a secure web-based environment.
    Citations:
    PubMed Identifier
    32956536
    Citation
    Garrison SR, Korownyk CS, Kolber MR, Allan GM, Musini VM, Sekhon RK, Dugre N. Magnesium for skeletal muscle cramps. Cochrane Database Syst Rev. 2020 Sep 21;9(9):CD009402. doi: 10.1002/14651858.CD009402.pub3.
    Results Reference
    derived

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    Topical Magnesium and Muscle Cramps in Dialysis Patients.

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