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Dietary Supplement

Exercise + Creatine + Coenzyme Q10 for Juvenile Myositis

Q: Is this experiment soliciting individuals aged 75 or above to participate?

This trial is recruiting participants aged between 7 and 18 years old.

Q: Is this research initiative accepting new participants?

Indeed, the details found on clinicaltrials.gov demonstrate that this investigation is in search of test subjects and opened its recruitment window on April 6th 2021. The most recent update was posted on May 4th 2022, with 15 patients sought from a single location.

Q: How many participants have enlisted in this trial so far?

Yes, the information published on clinicaltrials.gov indicates that this research is actively recruiting. The study was initially posted on April 6th 2021 and has since been modified on May 4th 2022. Altogether, 15 individuals will be recruited from one medical facility for the purpose of this experiment.

Q: Who qualifies to participate in this trial?

For eligibility in this clinical trial, patients must be between the ages of 7 to 18 and have myositis. The total number of participants is capped at 15 individuals.

N/A

Waitlist Available

Led By Brian Feldman, MD, MSc

Research Sponsored by The Hospital for Sick Children

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Ages 7 to 18 years

Diagnosis of juvenile idiopathic inflammatory myopathy (JIIM) according to the 2017 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) criteria: ≥90% probability, age of onset <18 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

Study Summary

This trial is studying if children with JDM who take creatine and coenzyme Q10 can get stronger and feel less tired.

Who is the study for?

This trial is for children aged 7 to 18 with juvenile idiopathic inflammatory myopathy (JIIM), who are at least 132.5cm tall to fit the exercise equipment, and on stable medication. It's not for those too weak for exercise tests, pregnant or planning pregnancy, with recent JIIM diagnosis (<6 months), impaired kidney function, or taking blood thinners.Check my eligibility

What is being tested?

The study is testing if creatine monohydrate and coenzyme Q10 supplements can help children with JDM feel stronger and less tired by improving muscle energy use and recovery after exercise. The goal is to improve their ability to do everyday activities and enhance their quality of life.See study design

What are the potential side effects?

Potential side effects from creatine may include muscle cramping, nausea, diarrhea, dizziness; while coenzyme Q10 might cause mild insomnia, digestive issues like upper abdominal pain or loss of appetite.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 7 and 18 years old.

Select...

I was diagnosed with JIIM before I turned 18.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in muscle function

Secondary outcome measures

Change in general fatigue

Change in muscle fatigue

Change in physical function

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: TreatmentExperimental Treatment3 Interventions

patients in this arm will be treated with creatine and coenzyme Q10 supplements

Group II: PlaceboPlacebo Group3 Interventions

patients in this arm will be given placebo supplements that look and taste identical to the active supplements

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

ubiquinol

2012

Completed Phase 1

~50

Exercise

2016

Completed Phase 1

~760

creatine monohydrate

2010

Completed Phase 3

~450

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

The Hospital for Sick ChildrenLead Sponsor

689 Previous Clinical Trials

6,945,406 Total Patients Enrolled

Brian Feldman, MD, MScPrincipal InvestigatorThe Hospital for Sick Children

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this experiment soliciting individuals aged 75 or above to participate?

"This trial is recruiting participants aged between 7 and 18 years old."

Answered by AI

Is this research initiative accepting new participants?

"Indeed, the details found on clinicaltrials.gov demonstrate that this investigation is in search of test subjects and opened its recruitment window on April 6th 2021. The most recent update was posted on May 4th 2022, with 15 patients sought from a single location."

Answered by AI

How many participants have enlisted in this trial so far?

"Yes, the information published on clinicaltrials.gov indicates that this research is actively recruiting. The study was initially posted on April 6th 2021 and has since been modified on May 4th 2022. Altogether, 15 individuals will be recruited from one medical facility for the purpose of this experiment."

Answered by AI

Who qualifies to participate in this trial?

"For eligibility in this clinical trial, patients must be between the ages of 7 to 18 and have myositis. The total number of participants is capped at 15 individuals."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Exercise, Creatine and Coenzyme Q10 for Childhood Myositis

Brian Feldman 2021. "Exercise, Creatine and Coenzyme Q10 for Childhood Myositis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04286178.