None listed
Conditions
Brief summary
Multiple sclerosis (MS) is rare but increasing in incidence. Our Australian work shows that five years of a first demyelinating event, 41% of people will have clinical fatigue with depression frequently comorbid. Single nutrient therapy with antioxidants directed to mitochondrial support have shown some benefit for fatigue and depression, oxidant damage prevention and improved clinical course in multiple sclerosis. This double-blind randomised controlled trial will run a 20-week therapy of combined mitochondrial support agents against placebo. The therapy will include coenzyme Q10, alpha-lipoic acid, N acetyl cysteine, biotin and other agents. Trial participants will be people with relapsing remitting multiple sclerosis with fatigue. The trial will assess the extent that these therapies reduce fatigue, depression, and metabolomic abnormalities in MS.
Interventions
Nine oral capsules containing a combination of:
1. N-Acetyl-cysteine (1000mg),
2. Acetyl L Carnitine (1000mg),
3. CoenzymeQ10 (600mg),
4. alpha lipoic acid (800mg),
5. combination capsule containing: Ascorbic acid (250mg), d-alpha-Tocopherol (equiv. vitamin E) 33.3 mg (52 IU), Thiamine nitrate (25 mg), Riboflavin (vitamin B2; 20 mg), Nicotinamide (vitamin B3; 20 mg), Biotin (vitamin H; 100 mg), Folinic acid (vitamin B9, 400 mcg)
Capsule 1-4 will be consumed twice a day, morning and evening C
Nine oral capsules containing a combination of: 1. N-Acetyl-cysteine (1000mg), 2. Acetyl L Carnitine (1000mg), 3. CoenzymeQ10 (600mg), 4. alpha lipoic acid (800mg), 5. combination capsule containing: Ascorbic acid (250mg), d-alpha-Tocopherol (equiv. vitamin E) 33.3 mg (52 IU), Thiamine nitrate (25 mg), Riboflavin (vitamin B2; 20 mg), Nicotinamide (vitamin B3; 20 mg), Biotin (vitamin H; 100 mg), Folinic acid (vitamin B9, 400 mcg) Capsule 1-4 will be consumed twice a day, morning and evening Capsule 5 will only be consumed in the morning. Capsules will be taken at the same time. These will be consumed each day for 16 weeks. The study coordinator or site-specific research staff will make phone/in person contact at 2, 4, 8, and 12 weeks post-baseline to ensure adverse events and any relapses are captured, to review concomitant medications, and to promote participant adherence to the intervention. If the participant experiences a serious adverse event (SAE) that is suspected to be linked to the study medication or compromises the participant’s ability to adhere to the intervention, the intervention will be ceased; however, the participant will remain in the trial and will be followed-up through to the end of the study.
Sponsors
Murdoch Children's Research Institute
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 65 Years
Healthy volunteers
No
Inclusion criteria
• Aged 18-65 years; • Diagnosed with RRMS by a neurologist; • EDSS of less than 6 within last 12 months (measurement recorded in the absence of an acute relapse or illness); • English speaking or non-English speaking patients that can ensure external interpreter assistance (e.g. from a relative, spouse or friend) for the onsite clinical visits and for the phone follow-up timepoints. • On stable MS therapy for more than/ equal to 8 weeks prior to enrolment; • Available to attend clinic visits within 1 week of each time point (baseline, week 16, and week 20); • Clinical fatigue (as evidenced by a FSS score more than 4 on two occasions when completing the test serially online over a fortnight); • Basic confidence and literacy with using a computer (e.g. able to use web browser, receive SMS messages).
Exclusion criteria
• Recent relapse of multiple sclerosis with onset within 12 weeks of recruitment interview • Known or suspected systemic medical disorder such as rheumatoid arthritis and kidney disease OR any medical condition (e.g. cognitive disorders, intellectual disability, Alzheimer’s disease) that investigators determine may affect participant adherence to the trial intervention • Previous cardiac events: angina, Coronary Artery Bypass Grafting (CABG), non- and ST elevated myocardial infarction (biotin can disrupt measurement of cardiac enzymes) • Currently prescribed thyroid-related medication (e.g. thyroxine) or diagnosed thyroid-related disorder • Pre-existing psychotropic therapy regimen needs to have been stable for 4 weeks prior to study entry • Pregnant or at risk of pregnancy (if female); • Current lactation; • Commenced or are scheduled to commence iron supplementation • Acute suicidality (score >1 on item 12 of a self-reported Quick Inventory of Depressive Symptomology Tool); • A current diagnosis of substance abuse/dependence; • Currently taking any illicit substances including any cannabis product (e.g. cannabis oil) • Recent gastrointestinal ulcers or renal stones; • Diagnosis of epilepsy; • Current use of any of the study preparations OR any multivitamin (eligible following a 3-week washout period); • Using > 200 mcg of selenium/day (antioxidant properties that are mechanistically similar to the study treatment). • Prescribed warfarin or phenytoin; • Allergy/intolerance to any study components; • No internet access or no access to computer/tablet or phone; • Unable or unlikely to attend the required study visits at the required timepoints or unable to complete the study protocol (e.g. upcoming travel, surgery) • Participant cannot be involved in any other interventional trial or study during the study period • Any other reason that the investigator team deems the individual to not be suitable for participation
Outcome results
None listed