Myositis, JuvenileNCT04286178
Exercise, Creatine and Coenzyme Q10 for Childhood Myositis
A study testing creatine monohydrate, ubiquinol and glucose tablet in people with Myositis, Juvenile, run by The Hospital for Sick Children at 1 site in Canada.
Trial summary
Children with Juvenile Idiopathic Inflammatory Myopathies (JIIM) are weak and get tired because their muscles aren't able to work like healthy muscles. This can make it hard for them to do normal everyday things and can make them less happy about their lives compared to children without the disease. Read more about this study
- Who is it for?
- Ages 7 to 18 years
- Conditions the study is for
- Myositis, Juvenile
- What is being tested?
- creatine monohydrate, ubiquinol and glucose tablet
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteCanada
- Study dates
- 6 Apr 2021to 5 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
- Subjects on a stable course of medication (unlikely to change over study treatment period as determined by treating physician)
- Minimum height of 132.5cm (required to fit on the cycle ergometer)
Who cannot join
- Subjects with newly diagnosed JIIM within the previous 6 months
- Subjects unable to cooperate with study procedures, or too weak to participate in the exercise testing
- Subjects with impaired kidney function as determined from pre-baseline visit screening lab values (eGFR <90 ml/min/1.73m^2)
- Subjects currently taking anti-hypertensive drugs or blood thinners
- Subjects who are currently pregnant or planning to become pregnant within the study period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Exercise, Creatine, and Coenzyme Q10 Supplementation on Muscle Function in Children With Myositis
Children with Juvenile Idiopathic Inflammatory Myopathies (JIIM) are weak and get tired because their muscles aren't able to work like healthy muscles. This can make it hard for them to do normal everyday things and can make them less happy about their lives compared to children without the disease. There are two nutritional supplements that help muscles use energy and recover after exercise: creatine and coenzyme Q10. If the muscle has more energy, it may not be as weak and may not feel as tired or sore after exercise. Because of this we want to see if having children with JIIM take creatine and coenzyme Q10 can make them stronger and less tired. If this works, we hope it will let them be able to do the things that healthy children can do, and make them feel better about their lives.
- Conditions
- Myositis, Juvenile
- Being tested
- creatine monohydrate, ubiquinol, glucose tablet, gel capsule, Exercise
- Medical subject headings
- Dermatomyositis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
creatine monohydrateDietary supplement
Creatine will be taken at a dose of 150mg/kg/day of creatine base divided into 2 daily doses up to 39.7kg in body weight, after which dosing will be based on body surface area (BSA) at 4.69g/m2/day. Creatine will be administered orally as a chewable tablet provided by BioTechUSA™. Tablets are 2g and contain 0.9g of creatine monohydrate which is equivalent to 0.8g of creatine base.
ubiquinolDietary supplement
Also called coenzyme Q10
Coenzyme Q10 (CoQ10, ubiquinol) will be taken at a dose of 10mg/kg/day divided into 2 daily doses with a daily maximum of 500mg. CoQ10 will be administered orally in 50mg softgels containing 50mg of ubiquinol (Active Q®), provided by Tishcon Corporation.
glucose tabletDietary supplement
Creatine placebo will be in the form of a glucose tablet with identical appearance and taste to the active supplement. The number of tablets/day will be determined based on the dose of creatine required for each patient.
gel capsuleDietary supplement
Ubiquinol placebo will be in the form of a gel capsule with identical appearance to the active supplement. The number of capsules/day will be determined based on the dose of ubiquinol required for each patient.
ExerciseBehavioural
Participants will be coached to hit 12,000 steps or 60 "active minutes" per day as logged by a FitBit (FitBit calculates active minutes as activities equivalent to moderate-to-vigorous physical activity (MVPA) done continuously for at least 10 minutes)
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | patients in this arm will be treated with creatine and coenzyme Q10 supplements Receives: Dietary Supplement: creatine monohydrate; Dietary Supplement: ubiquinol; Behavioral: Exercise |
| Placebo | Placebo comparator | patients in this arm will be given placebo supplements that look and taste identical to the active supplements Receives: Dietary Supplement: glucose tablet; Dietary Supplement: gel capsule; Behavioral: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in muscle function
Change in muscle function will be determined by the change in peak power achieved on the wingate anaerobic cycling test between the active supplement phase and the placebo phase
Measured: 6 months
Secondary outcomes (5)
Change in muscle fatigue
Change in muscle fatigue will be determined by the change in the fatigue index during the wingate test. Fatigue index is a percentage, and is calculated as follows: [(Peak Power - End Power)/Peak Power] x100
Measured: 6 months
Change in general fatigue
Change in fatigue will be determined by the change in the Pediatric Quality of Life - Fatigue Module scores (PedsQL-Fatigue). This measure is scored on a scale of 0-100 with 100 representing the least amount of fatigue.
Measured: 6 months
Change in quality of life
Change in quality of life will be determined by the change in the Quality of My Life questionnaire scores. Quality of my Life consists of 3 visual analog scales each scored out of 10. Higher scores indicate better quality of life.
Measured: 6 months
Change in physical function
Change in physical function will be determined by the change in the hand grip strength, measured using a hand dynamometer. Three attempts will be given per hand, and the maximum grip strength achieved (in kg displaced) will be recorded for each hand.
Measured: 6 months
Change in physical function
Change in physical function will be determined by the change in the vertical jump achieved, measured in centimeters
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2020
- Study start6 Apr 2021
- Primary completion5 Mar 2024
- Study completion5 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myositis, JuvenileStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This study will be a double-blinded, placebo-controlled, randomized, multiple baseline design (MBD) where each subject will be randomly allocated a start time for the active supplements
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brian M. Feldman, The Hospital for Sick Children
- Investigators
- Brian Feldman, MD, MSc, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04286178
- Sponsor's protocol ID
- 1000062314
- Other IDs
- HC6-24-c228771
- Status last verified
- Apr 2026
- First submitted
- 6 Feb 2020
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Exercise, Creatine, and Coenzyme Q10 Supplementation on Muscle Function in Children With Myositis
- ClinicalTrials.gov ID
- NCT04286178
- Acronym / sponsor ID
- 1000062314
- Conditions
- Myositis, Juvenile
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- 6 Apr 2021 (actual)
- Primary completion
- 5 Mar 2024 (actual)
- Study completion
- 5 Mar 2024 (actual)
- First posted
- 26 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Children with Juvenile Idiopathic Inflammatory Myopathies (JIIM) are weak and get tired because their muscles aren't able to work like healthy muscles. This can make it hard for them to do normal everyday things and can make them less happy about their lives compared to children without the disease. There are two nutritional supplements that help muscles use energy and recover after exercise: creatine and coenzyme Q10. If the muscle has more energy, it may not be as weak and may not feel as tired or sore after exercise. Because of this we want to see if having children with JIIM take creatine and coenzyme Q10 can make them stronger and less tired. If this works, we hope it will let them be able to do the things that healthy children can do, and make them feel better about their lives.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This study will be a double-blinded, placebo-controlled, randomized, multiple baseline design (MBD) where each subject will be randomly allocated a start time for the active supplements
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Dietary Supplement: creatine monohydrate, Dietary Supplement: ubiquinol, Behavioral: Exercisepatients in this arm will be treated with creatine and coenzyme Q10 supplements |
| Placebo | Placebo comparator | Dietary Supplement: glucose tablet, Dietary Supplement: gel capsule, Behavioral: Exercisepatients in this arm will be given placebo supplements that look and taste identical to the active supplements |
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
- Subjects on a stable course of medication (unlikely to change over study treatment period as determined by treating physician)
- Minimum height of 132.5cm (required to fit on the cycle ergometer)
Key exclusion criteria (5 listed)
- Subjects with newly diagnosed JIIM within the previous 6 months
- Subjects unable to cooperate with study procedures, or too weak to participate in the exercise testing
- Subjects with impaired kidney function as determined from pre-baseline visit screening lab values (eGFR <90 ml/min/1.73m^2)
- Subjects currently taking anti-hypertensive drugs or blood thinners
- Subjects who are currently pregnant or planning to become pregnant within the study period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| creatine monohydrateCreatine will be taken at a dose of 150mg/kg/day of creatine base divided into 2 daily doses up to 39.7kg in body weight, after which dosing will be based on body surface area (BSA) at 4.69g/m2/day. Creatine will be administered orally as a chewable tablet provided by BioTechUSA™. Tablets are 2g and contain 0.9g of creatine monohydrate which is equivalent to 0.8g of creatine base. | Dietary supplement | Treatment |
| ubiquinolAlso: coenzyme Q10Coenzyme Q10 (CoQ10, ubiquinol) will be taken at a dose of 10mg/kg/day divided into 2 daily doses with a daily maximum of 500mg. CoQ10 will be administered orally in 50mg softgels containing 50mg of ubiquinol (Active Q®), provided by Tishcon Corporation. | Dietary supplement | Treatment |
| glucose tabletCreatine placebo will be in the form of a glucose tablet with identical appearance and taste to the active supplement. The number of tablets/day will be determined based on the dose of creatine required for each patient. | Dietary supplement | Placebo |
| gel capsuleUbiquinol placebo will be in the form of a gel capsule with identical appearance to the active supplement. The number of capsules/day will be determined based on the dose of ubiquinol required for each patient. | Dietary supplement | Placebo |
| ExerciseParticipants will be coached to hit 12,000 steps or 60 "active minutes" per day as logged by a FitBit (FitBit calculates active minutes as activities equivalent to moderate-to-vigorous physical activity (MVPA) done continuously for at least 10 minutes) | Behavioural | Placebo, Treatment |
Primary outcome
Change in muscle function
Time frame: 6 months
Change in muscle function will be determined by the change in peak power achieved on the wingate anaerobic cycling test between the active supplement phase and the placebo phase
5 secondary outcomes
Change in muscle fatigue
Time frame: 6 months
Change in general fatigue
Time frame: 6 months
Change in quality of life
Time frame: 6 months
Change in physical function
Time frame: 6 months
Change in physical function
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian Feldman, MD, MSc principal investigator
The Hospital for Sick Children
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing creatine monohydrate, ubiquinol and glucose tablet in people with Myositis, Juvenile, run by The Hospital for Sick Children at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in muscle function (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.