None listed
Conditions
Brief summary
Chronic fatigue syndrome (CFS) is a prolonged multisystem illness, characterised by very poor stamina, delayed post-exertional fatigue, which adversely affects one’s functioning across numerous physical and mental domains. Current treatments for CFS include pharmacological (e.g. fluoxetine, rintatolimod, galantamine), psychological (e.g. cognitive behaviour therapy (CBT), adaptive pacing therapy), and lifestyle interventions. For many who remain in treatment, they continue to experience significant social, occupational, and functional impairment. Thus new treatment approaches are urgently needed. While significant fatigue remains a common complaint across numerous disorders, it is posited that CFS is related to metabolic dysfunction, mitochondrial dysfunction and impaired biogenesis, in turn related to oxidative stress and systemic inflammation. Mitochondria are structures within cells primarily responsible for energy generation, and are particularly active in oxygen-rich and highly energy dependent tissues, such as the brain. Recent research suggests that patients suffering from CFS may improve with the supplementation of mitochondrial nutrients and antioxidants. This supplementation may be associated with the reduction to mitochondrial membranes, restoring mitochondrial energy production, protecting cellular structures and enzymes from oxidative damage, and decreasing fatigue. Given that CFS is largely a heterogeneous illness associated with a complex and multifactorial aetiology, combined with the present state of available treatments, it is plausible that the introduction of a combination of metabolic therapies may have positive effects on mitochondrial dysfunction and lead to symptom improvement for CFS sufferers.
Interventions
This study aims to examine the efficacy of a novel, tolerable, and practical adjunctive intervention by examining a combination of agents acting on mitochondrial targets.
The trial will assess the efficacy and tolerability of twice daily dosing for 20-weeks of purpose-designed combination capsules taken orally providing a daily amount of: N-acetylcysteine (NAC) 2000 mg; Acetyl L-carnitine (ALC) 1000mg; ubiquinone (Co Q10) 200 mg; magnesium (as orotate 500mg) 64mg; calcium ascorbate dehydrate (
This study aims to examine the efficacy of a novel, tolerable, and practical adjunctive intervention by examining a combination of agents acting on mitochondrial targets. The trial will assess the efficacy and tolerability of twice daily dosing for 20-weeks of purpose-designed combination capsules taken orally providing a daily amount of: N-acetylcysteine (NAC) 2000 mg; Acetyl L-carnitine (ALC) 1000mg; ubiquinone (Co Q10) 200 mg; magnesium (as orotate 500mg) 64mg; calcium ascorbate dehydrate (equiv ascorbic acid 200mg) 242mg; cholecalciferol (equiv vitamin D3 250IU) 12.5micrograms; a-tocopherol (equiv natural vitamin E 50IU) 60IU; alpha lipoic acid 150mg; Retinyl palmitate (equiv vitamin A 3000IU) 900ugREIU; and vitamin B co-factors: biotin (vitamin H) (600micrograms), thiamin hydrochloride (100mg), riboflavin (100mg), nicotinamide (200mg), calcium pantothenate (100mg), pyridoxine hydrocholoride (100mg), folic acid (800micrograms), cyanocobalamin (vitamin B12) (800micrograms) in people diagnosed with CFS. A capsule count will be done to determine compliance.
Sponsors
The University of Melbourne
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 65 Years
Healthy volunteers
No
Inclusion criteria
a. Male and female patients aged 18 to 65 years, b. Diagnosed with chronic fatigue syndrome by an independent physician (a letter or referral will be preferred to confirm diagnosis), c. Fulfil criteria for CFS as per the US Centres for Disease Control and Prevention (CDC), which requires persistent, unexplained fatigue for at least 6 months, concurrent with at least four of the following, 1) Impaired memory/concentration, 2) Sore throat, new headaches, 3) Unfreshreshing sleep, muscle pain, 4) Multi-joint pain 5)Tender lymph nodes 6) Post-exertional malaise d. Have capacity to consent to the study and comply with study procedures, e. Be using effective contraception if female, sexually active and of childbearing age, f. Participants currently under any form of therapy will need to have been on that therapy for at least four (4) weeks prior to enrolment.
Exclusion criteria
a. Patients with known or suspected active and unstable systemic medical disorder, b. Patients who have a major depressive episode in the two years preceding the diagnosis of CFS, c. Acute suicidality as indicated by a score of 5 or 6 on Item 10 of the MADRS (or at the discretion of Principal Investigator) d. Patients with current diagnosis of a psychotic disorder, bipolar disorder, substance abuse/dependence, eating disorder, significant personality disorder, e. Recent gastrointestinal ulcers or renal stones, f. Individuals who are pregnant or lactating, g. Individuals with a diagnosis of epilepsy, h. Those who are currently taking any of the study preparations (a 2-week washout period will be required if participants currently taking the study preparations would like to take part) or over 200micrograms of selenium/day, i. Individuals currently enrolled in any other intervention study, j. Individuals needing warfarin or phenytoin, k. Individuals who are intolerant to or have had an anaphylactic reaction to any components of the preparation, l. Inability to comply with either the requirements of informed consent or the treatment protocol.
Outcome results
None listed