Topical magnesium oil for the treatment of neuropathic symptoms in stage IV and V chronic kidney disease

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12621000841875

Enrollment

Registered

2021-07-01

Start date

2022-01-18

Completion date

2022-10-11

Last updated

2023-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Neuropathic pain and symptoms are chronic debilitating problems that commonly affect people with advanced kidney disease. Most currently available treatments are taken orally, and may be associated with significant side effects. Also, people with advanced kidney disease are on many medications, and adding additional medications increases the risk of drug interactions. Topical magnesium may represent an alternative treatment for these bothersome symptoms and due to local application, the risk of side effects and drug interactions may be lower. The objective of this study is to determine the effectiveness of daily application of topical magnesium oil for the treatment of neuropathic symptoms (pain, numbness, cramping) in people with stage IV or V chronic kidney disease. The study will also examine the impact of using magnesium oil on quality of life, blood magnesium concentrations and any adverse effects from using magnesium oil. This study will run for a period of 12 weeks, with follow up scheduled every 4 weeks.

Interventions

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.

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

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)

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.

Outcome results