MedTrace Logo

Effect of CoQ10 Plus Selenium Supplementation on Clinical Outcomes and Biochemical Markers in ME/CFS (CoSeME Study)

NCT05128292 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2021-11-19

No results posted yet for this study

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.

Conditions

  • Myalgic Encephalomyelitis

Interventions

DIETARY_SUPPLEMENT

CoQ10 plus Selenium

400 mg/day CoQ10 soft gel capsula (Bio-Quinone active 100 mg b.i.d) plus 200 microgram organic selenium yeast tablet (SelenoPrecise 100 microgram b.i.d.) over 8 weeks

Sponsors & Collaborators

  • Pharma Nord

    collaborator INDUSTRY

  • Hospital Universitari Vall d'Hebron Research Institute

    lead OTHER

Principal Investigators

  • José Alegre, MD, PhD · Vall d'Hebron University Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-01
Primary Completion
2018-09-01
Completion
2018-11-30

Countries

  • Spain

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05128292 on ClinicalTrials.gov