Coenzyme Q10 for Chronic Fatigue Syndrome

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Overseen ByJanis B. Ritchie, BSN
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: University of California, San Diego
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether a supplement called coenzyme Q10 can help individuals experiencing chronic fatigue symptoms after the February 2023 train derailment in East Palestine, Ohio. Participants will receive either the coenzyme Q10 supplement or a placebo (a pill with no active ingredient) to compare effects. The trial aims to determine if this supplement can improve quality of life and physical function for those affected. Individuals who lived within 10 miles of the derailment and have experienced new or worsened fatigue, pain, or other symptoms since then might be suitable candidates. Participants need internet access and must be willing to follow study instructions. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

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.

Is there any evidence suggesting that coenzyme Q10 is likely to be safe for humans?

Research has shown that Coenzyme Q10 (CoQ10) is generally safe as a dietary supplement. Studies suggest that taking up to 1,200 mg per day is unlikely to cause harm, though most people take a lower dose, usually between 100 to 200 mg daily. In this trial, participants will take 100 mg three times a day. Other studies have used CoQ10 to help manage symptoms of chronic fatigue syndrome, with no serious side effects reported.

Although specific safety data from this study is not yet available, CoQ10 is already known to be well-tolerated in humans. For those considering joining the trial, the safety of CoQ10 appears promising based on past research.12345

Why do researchers think this study treatment might be promising for chronic fatigue syndrome?

Unlike the standard treatments for Chronic Fatigue Syndrome, which often involve medications like antidepressants, cognitive behavioral therapy, or graded exercise therapy, Coenzyme Q10 (CoQ10) offers a unique approach. CoQ10 is a naturally occurring antioxidant that plays a vital role in energy production within cells. Researchers are excited about CoQ10 because it targets mitochondrial function, potentially addressing the root cause of energy depletion in Chronic Fatigue Syndrome. Additionally, since CoQ10 is taken as a supplement, it may offer a more natural and potentially safer alternative to conventional medications.

What evidence suggests that Coenzyme Q10 might be an effective treatment for chronic fatigue syndrome?

Studies have shown that Coenzyme Q10 (CoQ10) can help reduce feelings of tiredness. This trial will provide participants with either CoQ10 or a placebo to explore its potential as a treatment for chronic fatigue syndrome (CFS), which includes symptoms like tiredness, pain, and sleep problems. Research suggests that CoQ10, especially when combined with other nutrients like selenium, might improve the quality of life for people with CFS. Some studies indicate that CoQ10 can increase energy and enhance physical activity. Overall, the evidence supports CoQ10's potential as an effective option for easing fatigue and related symptoms.678910

Who Is on the Research Team?

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Beatrice A. Golomb, MD, PhD

Principal Investigator

University of California, San Diego

Are You a Good Fit for This Trial?

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.
See 2 more

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.
See 1 more

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
2Treatment groups
Active Control
Placebo Group
Group I: CoQ10 ArmActive Control1 Intervention
Group II: Placebo ArmPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials
1,215
Recruited
1,593,000+

Citations

Effectiveness of Coenzyme Q10 Supplementation for ...Based on the results of this meta-analysis, we conclude that CoQ10 is an effective and safe supplement for reducing fatigue symptoms.
Effect of CoQ10 Plus Selenium Supplementation on ...Coenzyme Q10 (CoQ10) has been studied as an alternative and complementary therapy in ME/CFS for fatigue, pain, tiredness, neurocognitive impairment, and sleep ...
Randomized control trials Effect of coenzyme Q 10 plus ...Our results suggest that CoQ10 plus NADH supplementation for 8 weeks is safe and potentially effective in reducing max HR during a cycle ergometer test and also ...
Mitochondrial Dysfunction and Coenzyme Q10 ...Based on these findings, long-term supplementation with CoQ10 plus selenium suggests a potentially beneficial synergistic effect in patients with ME/CFS. 4.3.
Effect of Dietary Coenzyme Q10 Plus NADH ...Our results showed that the combination of CoQ10 plus NADH had a positive effect on the perception of fatigue, sleep quality, and HRQoL in ME/CFS. This was ...
Coenzyme Q10 - StatPearls - NCBI BookshelfCoQ10 is safe as a dietary supplement. Toxicity is unlikely up to a daily intake of 1200 mg/d, although typical dosages have been 100 to 200 mg/ ...
Coenzyme Q10 Plus NADH Supplementation in Chronic ...The main aim of the study is to examine the effect of oral CoQ10 plus NADH (Reconnect®) supplementation twice daily for 8-weeks on the changes in fatigue ...
Mitochondrial Dysfunction and Coenzyme Q10 ...It aims to evaluate the effectiveness of coenzyme Q10 supplementation on chronic fatigue and pain symptoms as a novel therapeutic strategy for the treatment of ...
Effect of Dietary Coenzyme Q10 Plus NADH ...Effect of Dietary Coenzyme Q10 Plus NADH Supplementation on Fatigue Perception and Health-Related Quality of Life in Individuals with Myalgic Encephalomyelitis/ ...
Coenzyme Q10 supplementation – In ageing and diseaseAlleviation of symptoms of chronic fatigue syndrome or myalgic encephalopathy has also been reported after supplementation with CoQ10 combined with a niacin ...
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