Clinical Trials Logo

Clinical Trial Summary

In recent years, it has been suggested that nutritional deficiencies may be of causal relevance in individuals with ME/CFS. These include deficiencies of vitamins and trace elements. It is likely that the observed nutritional deficiencies contribute to the core symptoms of the disease. Coenzyme Q10 (CoQ10) has been studied as an alternative and complementary therapy in ME/CFS for fatigue, pain, tiredness, neurocognitive impairment, and sleep problems. This demonstrates how alterations in energy metabolism, mitochondrial dysfunction, oxidative stress, imbalance of the immune-inflammatory response, and activation of the NLRP3 inflammasome are likely consequences of low levels of CoQ10 and selenium, which are related to the main symptoms in ME/CFS. Hypothesis: CoQ10 and selenium levels are decreased in ME/CFS patients. A natural therapeutic alternative in the treatment of common symptoms in ME/CFS could be the oral CoQ10 (Ubiquinone) plus selenium supplementation to module redox status and inflammation response in ME/CFS. Aims: To evaluate the efficacy of oral Ubiquinone + selenium supplementation on clinical outcome and circulating biomarkers in ME/CFS. We enrolled 42 ME/CFS patients diagnosed according to the 1994 CDC/Fukuda criteria who have received oral treatment of 400 mg Ubiquinone + 200 microgram selenium daily for 8 weeks. Demographic, clinical characteristics and laboratory variables, and validated outcome measures to perceived fatigue, sleep disturbances, and quality of life will be also evaluated. In addition, plasma biomarkers related to oxidative stress status (total antioxidant capacity and lipoperoxide levels), inflammatory response (pro-and anti-inflammatory cytokines), and cardiovascular dysfunction (FGF-21 and NT-proBNP) will be assayed.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT05128292
Study type Interventional
Source Hospital Universitari Vall d'Hebron Research Institute
Contact
Status Completed
Phase N/A
Start date January 1, 2018
Completion date November 30, 2018

See also
  Status Clinical Trial Phase
Recruiting NCT05454683 - Melatonin and Zinc Administration on Cardinal Symptoms in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome N/A
Recruiting NCT05059184 - Long-term Sequelae of COVID-19 (Myalgic Encephalomyelitis): An International Cross-Sectional Study
Recruiting NCT04542161 - Assessment of N-Acetylcysteine as Therapy for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome Phase 2
Terminated NCT01730495 - Tumor Necrosis Factor-alpha Inhibition Using Etanercept in Chronic Fatigue Syndrome Phase 2
Completed NCT01156909 - B-cell Depletion Using the Monoclonal Anti-CD20 Antibody Rituximab in Chronic Fatigue Syndrome Phase 2
Active, not recruiting NCT05167227 - Does a Technology Enabled Multi-disciplinary Team-based Care Model for the Management of Long COVID and Other Fatiguing Illnesses Improve Clinical Care of Patients and Represent a Sustainable Approach Within a Federally Qualified Health Center? N/A
Recruiting NCT05741112 - The Long COVID-19 Wearable Device Study N/A
Completed NCT04301609 - Clinical Trial to Assess the Improvement of Fatigue, Sleep Problems, Anxiety / Depression, Neurovegetatives Alterations and Quality of Life After the Administration of ImmunoVita® in Chronic Fatigue Syndrome Patients N/A
Completed NCT05196529 - Inspiratory Muscle Training in ME/CFS and COVID-19 Survivors N/A
Completed NCT00920777 - Survey and Cognitive Behavior Therapy for Chronic Fatigue Syndrome/Myalgic Encephalomyelitis N/A
Completed NCT04741841 - Effect of Probiotics in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) N/A
Enrolling by invitation NCT03254823 - Autoimmunity in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)
Recruiting NCT05236465 - A 3-day Course for CFS/ME N/A
Recruiting NCT04100915 - A Non-Interventional Pilot Study to Explore the Role of Gut Flora in ME/CFS
Active, not recruiting NCT05664711 - Effect of Stellate Ganglion Block on ME/CFS Phase 1
Enrolling by invitation NCT05273372 - RESTORE ME -- RCT of Oxaloacetate on Improving Fatigue in ME/CFS N/A
Completed NCT02970240 - Cardiopulmonary Testing in ME/CFS to Improve Diagnostic Accuracy
Terminated NCT01156922 - B-cell Depletion Using the Monoclonal Anti-CD20 Antibody Rituximab in Very Severe Chronic Fatigue Syndrome Phase 2
Enrolling by invitation NCT03409653 - Complex Chronic Diseases Program Data Registry
Completed NCT03613129 - Clinical Trial to Investigate CT38 in the Treatment of Myalgic Encephalomyelitis / Chronic Fatigue Syndrome Phase 1/Phase 2