Coenzyme Q10 for Chronic Fatigue Syndrome

Overseen By Janis B. Ritchie, BSN

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of California, San Diego

Must not be taking: Coumadin

Disqualifiers: Chronic infection, Active cancer, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

20 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are using coumadin due to potential interactions with CoQ10.

What data supports the effectiveness of the treatment Coenzyme Q10 for Chronic Fatigue Syndrome?

Research shows that Coenzyme Q10, often combined with other supplements like NADH, can significantly reduce fatigue and improve quality of life in patients with Chronic Fatigue Syndrome. Studies have demonstrated improvements in fatigue perception, sleep quality, and overall health-related quality of life, suggesting CoQ10 as a potentially effective treatment for managing symptoms of this condition. ^{1 2 3 4 5}

Is Coenzyme Q10 safe for humans?

Coenzyme Q10 is generally considered safe for humans, with studies showing only one minor gastrointestinal side effect in 602 participants. Animal studies also found no toxic effects at high doses. ^{1 2 3 5 6}

How does Coenzyme Q10 treatment differ from other treatments for Chronic Fatigue Syndrome?

Coenzyme Q10 is unique because it targets mitochondrial dysfunction and oxidative stress, which are believed to contribute to Chronic Fatigue Syndrome. Unlike other treatments, it acts as an antioxidant and supports energy production in cells, potentially reducing fatigue and improving quality of life. ^{1 2 3 5 7}

What is the purpose of this trial?

This research study is being conducted to see if coenzyme Q10 (a nutritional supplement) might help to prevent and/or alleviate symptoms and health consequences and help to improve quality of life and physical function in residents affected by the February 2023 East Palestine, Ohio train derailment. This is a pilot study that is not powered to achieve benefit but seek to examine effect size and variance to aid in power calculations for a potential future better powered study.

Research Team

Beatrice A. Golomb, MD, PhD

Principal Investigator

University of California, San Diego

Eligibility Criteria

This trial is for individuals with Chronic Fatigue Syndrome potentially linked to the East Palestine, Ohio train derailment in February 2023. It's a pilot study to see if Coenzyme Q10 can help improve their quality of life and physical function.

Inclusion Criteria

Access to internet and smart phone or computer for remote Qualtrics survey participation.

Took ≥80% of run-in soft gels.

Willing to perform the stipulated study elements.

Exclusion Criteria

Anticipated move from the area or other anticipated obstacle to participating for study duration.

Participating in another clinical trial.

I cannot take CoQ10 due to my current medication.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Treatment Phase 1

Participants receive CoQ10 or placebo for the first treatment phase

3 months

Monthly visits (in-person)

Crossover Treatment Phase 2

Participants switch treatments (CoQ10 or placebo) for the second phase

3 months

Monthly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

Treatment Details

Interventions

• Coenzyme Q10

Trial Overview The study tests whether taking Ubiquinone (Coenzyme Q10) at 100 mg orally helps against symptoms compared to a placebo. This initial research will inform future studies by assessing effect size and variance.

Participant Groups

Group I: CoQ10 Arm Active Control 1 Intervention

Ubiquinone soft gel 100mg/3x day

Group II: Placebo Arm Placebo Group 1 Intervention

Soft gel placebo 3x/day

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials

1,215

Recruited

1,593,000+

References

1. England pubmed.ncbi.nlm.nih.gov

Effect of coenzyme Q10 plus nicotinamide adenine dinucleotide supplementation on maximum heart rate after exercise testing in chronic fatigue syndrome - A randomized, controlled, double-blind trial. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Does oral coenzyme Q10 plus NADH supplementation improve fatigue and biochemical parameters in chronic fatigue syndrome? [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Effect of Dietary Coenzyme Q10 Plus NADH Supplementation on Fatigue Perception and Health-Related Quality of Life in Individuals with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome: A Prospective, Randomized, Double-Blind, Placebo-Controlled Trial. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Does Coenzyme Q10 Plus Selenium Supplementation Ameliorate Clinical Outcomes by Modulating Oxidative Stress and Inflammation in Individuals with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome? [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Effectiveness of Coenzyme Q10 Supplementation for Reducing Fatigue: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. [2022]

6. Japan pubmed.ncbi.nlm.nih.gov

Thirteen-week repeated dose oral toxicity study of coenzyme Q10 in rats. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Coenzyme Q10 depletion in medical and neuropsychiatric disorders: potential repercussions and therapeutic implications. [2022]