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Trial registered on ANZCTR


Registration number
ACTRN12621000841875
Ethics application status
Approved
Date submitted
26/05/2021
Date registered
1/07/2021
Date last updated
5/05/2023
Date data sharing statement initially provided
1/07/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Topical magnesium oil for the treatment of neuropathic symptoms in stage IV and V chronic kidney disease
Scientific title
Topical magnesium oil for the treatment of neuropathic symptoms in stage IV and V chronic kidney disease
Secondary ID [1] 304322 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Peripheral Neuropathy 322075 0
Stage IV/V Chronic Kidney Disease 322076 0
Condition category
Condition code
Neurological 319794 319794 0 0
Other neurological disorders
Renal and Urogenital 319795 319795 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Transdermal Magnesium applied topically to any or all limbs.
Volume applied topically: 1 mL to each effected limb (max 4 limbs) daily for 12 weeks.
Dose of magnesium: 1 mL contains 144 mg of magnesium chloride.
Compliance will be monitored using a daily compliance form, on which, participants will be asked to record whether on not the intervention was used on any given day. The compliance form will be reviewed every follow up appointment.
Intervention code [1] 320672 0
Treatment: Drugs
Comparator / control treatment
No control group

This is a single arm, open label pilot study.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 327657 0
Change in frequency and severity of peripheral neuropathy during the 12 week trial period, as evaluated by the Neuropathy Total Symptom Score 6 [NTSS-6].
Timepoint [1] 327657 0
Participants will be assessed every 4 weeks for a total duration of 12 weeks.
At each of these follow up periods, participants will be assessed for the following:
Baseline (Pre intervention) - NTSS-6
Week 4 (post intervention) - NTSS-6
Week 8 (post intervention) - NTSS-6
Week 12 (post intervention) - NTSS-6

12 weeks represents the end of the follow-up period
Secondary outcome [1] 396133 0
Determine change in quality of life based on EQ-5D-5L
Timepoint [1] 396133 0
Participants will be assessed every 4 weeks for a total duration of 12 weeks.
At each of these follow up periods, participants will be assessed for the following:
Baseline (Pre intervention) - EQ-5D-5L
Week 4 (post intervention) - EQ-5D-5L
Week 8 (post intervention) - EQ-5D-5L
Week 12 (post intervention) - EQ-5D-5L

12 weeks represents the end of the follow-up period
Secondary outcome [2] 396134 0
Determine benefits on other domains (for example: pruritus) as assessed by the Integrated Palliative Care Outcome Scale (IPOS)
Timepoint [2] 396134 0
Participants will be assessed every 4 weeks for a total duration of 12 weeks.
At each of these follow up periods, participants will be assessed for the following:
Baseline (Pre intervention) - IPOS
Week 4 (post intervention) - IPOS
Week 8 (post intervention) - IPOS
Week 12 (post intervention) - IPOS
Secondary outcome [3] 396135 0
Determine change in plasma magnesium concentrations during study period (mmol/L)
Timepoint [3] 396135 0
Participants will be assessed every 4 weeks for a total duration of 12 weeks.
At each of these follow up periods, participants will be assessed for the following:
Baseline (Pre intervention) - serum magnesium concentration (mmol/L)
Week 4 (post intervention) - serum magnesium concentration (mmol/L)
Week 8 (post intervention) - serum magnesium concentration (mmol/L)
Week 12 (post intervention) - serum magnesium concentration (mmol/L)
Secondary outcome [4] 396136 0
Evaluate adverse events associated with magnesium treatment (e.g. local reactions to skin)
This will be evaluated in accordance with the Common Terminology Criteria for Adverse Events [CTCAE 4.0) for skin and subcutaneous tissue disorders.
Timepoint [4] 396136 0
Assessed every 4 weeks for 12 weeks
Secondary outcome [5] 396137 0
Treatment compliance (assessed using the treatment compliance form)
This form was developed specifically for this study, and will be distributed to participants on enrolment into the study
Timepoint [5] 396137 0
A self completed daily compliance form. Record from participants will be reviewed every 4 weeks for 12 weeks

Eligibility
Key inclusion criteria
Inclusion Criteria:
Stage IV or V chronic kidney disease (estimated GFR < 30 mL/min) referred to Renal Supportive Care Service at Royal Prince Alfred Hospital.
Symptoms of neuropathy (pain, paraesthesia, cramping)
No contraindication to use of topical magnesium oil (e.g. pre-existing skin condition which may be exacerbated)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Inability to provide informed consent (e.g. cognitive impairment)
Inability to read/speak/understand English
Baseline serum magnesium concentration greater than 1.10 mmol/L.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Sample size calculation – Pilot study of 20 participants
The sample size of twenty is based on the feasibility of recruiting participants with advanced kidney disease, in whom there are no cognitive impairment or other exclusion criterion. The investigators have access to magnesium oil for twenty participants, provided free of charge by DPP Pharmaceuticals.

Analysis plan
Intention to treat and per-protocol analyses will be performed.
1. Basic demographic and health data – age, gender, stage of kidney disease (IV or V), current medications [descriptive statistics]
2. NTSS-6 from baseline over follow up period [t-tests or equivalent non-parametric test]
3. EQ-5D-5L from baseline over follow up period [t-tests or equivalent non-parametric test]
4. IPOS scores from baseline over follow up period [t-tests or equivalent non-parametric test]
5. Serum magnesium concentration change from baseline over follow up period [t-tests or equivalent non-parametric test]
6. Incidence and severity of adverse events [descriptive statistics]
7. Treatment compliance [descriptive statistics]

Data will be collected and analyzed for each time point – that is; baseline, weeks 4, 8 and 12.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
5/07/2021
Actual
18/01/2022
Date of last participant enrolment
Anticipated
31/08/2022
Actual
11/10/2022
Date of last data collection
Anticipated
30/11/2022
Actual
29/11/2022
Sample size
Target
20
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 19556 0
Royal Prince Alfred Hospital - Camperdown
Recruitment postcode(s) [1] 34166 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 308697 0
Hospital
Name [1] 308697 0
Royal Prince Alfred Hospital
Country [1] 308697 0
Australia
Primary sponsor type
Hospital
Name
Royal Prince Alfred Hospital
Address
Royal Prince Alfred Hospital, Sydney Local Health District, NSW Health
Missenden Road, Camperdown, NSW, 2050
Country
Australia
Secondary sponsor category [1] 309583 0
None
Name [1] 309583 0
Address [1] 309583 0
Country [1] 309583 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308619 0
Sydney Local Health District (SLHD) - RPA Zone
Ethics committee address [1] 308619 0
Ethics committee country [1] 308619 0
Australia
Date submitted for ethics approval [1] 308619 0
07/04/2021
Approval date [1] 308619 0
14/05/2021
Ethics approval number [1] 308619 0
X21-0104 & 2021/ETH00676

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 111342 0
Dr Akshay Athavale
Address 111342 0
Level 9, Transplantation Offices, Royal Prince Alfred Hospital
Missenden Road, Camperdown, NSW, 2050
Country 111342 0
Australia
Phone 111342 0
+61295157755
Fax 111342 0
Email 111342 0
akshay.athavale@health.nsw.gov.au
Contact person for public queries
Name 111343 0
Akshay Athavale
Address 111343 0
Level 9, Transplantation Offices, Royal Prince Alfred Hospital
Missenden Road, Camperdown, NSW, 2050
Country 111343 0
Australia
Phone 111343 0
+61295157755
Fax 111343 0
Email 111343 0
akshay.athavale@health.nsw.gov.au
Contact person for scientific queries
Name 111344 0
Akshay Athavale
Address 111344 0
Level 9, Transplantation Offices, Royal Prince Alfred Hospital
Missenden Road, Camperdown, NSW, 2050
Country 111344 0
Australia
Phone 111344 0
+61295157755
Fax 111344 0
Email 111344 0
akshay.athavale@health.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
11770Study protocol  akshay.athavale@health.nsw.gov.au Available after contact with Principal Investigato... [More Details]
11771Statistical analysis plan  akshay.athavale@health.nsw.gov.au Available after contact with Principal Investigato... [More Details]
11772Clinical study report  akshay.athavale@health.nsw.gov.au Available after contact with Principal Investigato... [More Details]
11773Ethical approval  akshay.athavale@health.nsw.gov.au Available after contact with Principal Investigato... [More Details]



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.