Chronic Kidney DiseasesPhase 2NCT03082625
Topical Magnesium and Muscle Cramps in Dialysis Patients.
A Phase 2 study testing Transdermal Magnesium in people with Chronic Kidney Diseases and End Stage Renal Disease, run by Sir Charles Gairdner Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Diseases, End Stage Renal Disease, Dialysis Related Complications
- What is being tested?
- Transdermal Magnesium
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2017to 31 Dec 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Topical Magnesium Supplementation for the Treatment of Muscle Cramps in Dialysis Patients
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.
Read the 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.
- Being tested
- Transdermal Magnesium, Placebo
- Medical subject headings
- Renal Insufficiency, Chronic, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transdermal MagnesiumDrug
Also called Topical Magnesium
Magnesium
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Transdermal Magnesium | Experimental | 5 sprays each on the 2 most effected areas for muscle cramps twice a day Receives: Drug: Transdermal Magnesium |
| Placebo | Placebo comparator | 5 sprays each on the 2 most effected areas for muscle cramps twice a day Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in the average number of muscle cramps per week between magnesium and placebo treatments
final 3 weeks
Measured: 3 weeks
Secondary outcomes (4)
Difference in average cramp duration between magnesium and placebo treatments
final 3 weeks
Measured: 3 weeks
Difference in average cramp severity between magnesium and placebo treatments
final 3 weeks
Measured: 3 weeks
Percentage change in serum magnesium concentration from baseline and at the end of each treatment stage
Measured: 3 weeks
Difference in restless legs symptoms between the magnesium and placebo treatment stages.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2017
- Study start1 May 2017 (estimated)
- Primary completion31 Mar 2018 (estimated)
- Study completion31 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised placebo-controlled
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sir Charles Gairdner Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Neil Boudville, Sir Charles Gairdner Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03082625
- Sponsor's protocol ID
- 2016-158
- Status last verified
- Mar 2017
- First submitted
- 13 Mar 2017
- Last updated
- 17 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The plan at this stage is to have unidentified information available in a secure web-based environment.
Publications
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.
PubMed 32956536
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Magnesium Supplementation for the Treatment of Muscle Cramps in Dialysis Patients
- ClinicalTrials.gov ID
- NCT03082625
- Acronym / sponsor ID
- 2016-158
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Sir Charles Gairdner HospitalUniversity, hospital or other
- Study start
- 1 May 2017 (estimated)
- Primary completion
- 31 Mar 2018 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 17 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomised placebo-controlled
| Arm | Type | Receives |
|---|---|---|
| Transdermal Magnesium | Experimental | Drug: Transdermal Magnesium5 sprays each on the 2 most effected areas for muscle cramps twice a day |
| Placebo | Placebo comparator | Drug: Placebo5 sprays each on the 2 most effected areas for muscle cramps twice a day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transdermal MagnesiumAlso: Topical MagnesiumMagnesium | Drug | Transdermal Magnesium |
| Placebo | Drug | Placebo |
Primary outcome
Difference in the average number of muscle cramps per week between magnesium and placebo treatments
Time frame: 3 weeks
final 3 weeks
4 secondary outcomes
Difference in average cramp duration between magnesium and placebo treatments
Time frame: 3 weeks
Difference in average cramp severity between magnesium and placebo treatments
Time frame: 3 weeks
Percentage change in serum magnesium concentration from baseline and at the end of each treatment stage
Time frame: 3 weeks
Difference in restless legs symptoms between the magnesium and placebo treatment stages.
Time frame: 3 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2017.
- Derived from this study: PubMed 32956536Garrison 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.
- Individual participant dataSharing planned: Undecided. The plan at this stage is to have unidentified information available in a secure web-based environment.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Transdermal Magnesium in people with Chronic Kidney Diseases and End Stage Renal Disease, run by Sir Charles Gairdner Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Neil C Boudville, MBBS MMedSci (61-8-6457-3333, neil.boudville@uwa.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in the average number of muscle cramps per week between magnesium and placebo treatments (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03082625, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2017.