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
About this trial
This is an interventional treatment trial for Chronic Kidney Diseases
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.
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
NCT ID
NCT03082625
First Posted
March 13, 2017
Last Updated
March 16, 2017
Sponsor
Sir Charles Gairdner Hospital
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
Learn more about this trial
Topical Magnesium and Muscle Cramps in Dialysis Patients.
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