NCT03082625

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started May 2017

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 13, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 17, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2018

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

March 17, 2017

Status Verified

March 1, 2017

Enrollment Period

11 months

First QC Date

March 13, 2017

Last Update Submit

March 16, 2017

Conditions

Chronic Kidney DiseasesEnd Stage Renal DiseaseDialysis Related Complications

Outcome Measures

Primary Outcomes (1)

  • Difference in the average number of muscle cramps per week between magnesium and placebo treatments

    final 3 weeks

    3 weeks

Secondary Outcomes (4)

  • Difference in average cramp duration between magnesium and placebo treatments

    3 weeks

  • Difference in average cramp severity between magnesium and placebo treatments

    3 weeks

  • Percentage change in serum magnesium concentration from baseline and at the end of each treatment stage

    3 weeks

  • Difference in restless legs symptoms between the magnesium and placebo treatment stages.

    3 weeks

Study Arms (2)

Transdermal Magnesium

EXPERIMENTAL

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

Drug: Transdermal Magnesium

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Transdermal MagnesiumDRUG

Magnesium

Also known as: Topical Magnesium
Transdermal Magnesium
PlaceboDRUG
Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 32956536DERIVED

MeSH Terms

Conditions

Renal Insufficiency, ChronicKidney Failure, Chronic

Interventions

Magnesium

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Metals, Alkaline EarthElementsInorganic ChemicalsMetals, LightMetals

Central Study Contacts

Neil C Boudville, MBBS MMedSci

CONTACT

61-8-6457-3333neil.boudville@uwa.edu.au

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Identical delivery systems and appearance of the product
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomised placebo-controlled
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Deparment of Renal Medicine

Study Record Dates

First Submitted

March 13, 2017

First Posted

March 17, 2017

Study Start

May 1, 2017

Primary Completion

March 31, 2018

Study Completion

December 31, 2018

Last Updated

March 17, 2017

Record last verified: 2017-03