None listed
Conditions
Brief summary
To determine if a combination mitochondrial-based therapy using over-the-counter supplements can result in an improvement in the sensation of nerve-related pain in people with diabetes-related painful peripheral neuropathy.
Interventions
For this combination mitochondrial-based therapy, one tablet of each of four over-the-counter supplements (or placebo) will be taken orally, once daily, for 16 weeks. The supplements may include: Coenzyme Q10, magnesium, alpha-lipoic acid and thiamine.
Adherence will be monitored through study medication diary and medication capsule return.
Sponsors
Melbourne Health/Royal Melbourne Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Adults aged 18 years or greater who have been diagnosed with type 2 diabetes (according to WHO criteria) in adulthood and have diabetes-related painful peripheral neuropathy as confirmed with the Michigan Neuropathy Screening Instrument (MNSI)
Exclusion criteria
Active foot ulcer and/or infections, eGFR <30ml/min/1.73m2 (as calculated by the CKD-EPI creatinine formula), cirrhosis of the liver, bleeding disorders or use of oral anticoagulant medications, untreated active vitamin B12 deficiency, women who are lactating, pregnant or intend to become pregnant during the course of the study, cancer treated in the 12 months prior
Outcome results
None listed