- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04286178
Exercise, Creatine and Coenzyme Q10 for Childhood Myositis
March 20, 2024 updated by: Brian Feldman, The Hospital for Sick Children
The Effects of Exercise, Creatine, and Coenzyme Q10 Supplementation on Muscle Function in Children With Myositis
Children with JDM 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 JDM 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 Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
15
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Brian Feldman, MD, MSc
- Phone Number: 416-813-7707
- Email: brian.feldman@sickkids.ca
Study Contact Backup
- Name: Kayla Baker, B.Sc.
- Phone Number: 409338 416-813-7654
- Email: kayla.baker@sickkids.ca
Study Locations
-
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Ontario
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Toronto, Ontario, Canada, M5G 1X8
- The Hospital for Sick Children
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
5 years to 16 years (Child, Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment
patients in this arm will be treated with creatine and coenzyme Q10 supplements
|
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.
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.
Other Names:
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)
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Placebo Comparator: Placebo
patients in this arm will be given placebo supplements that look and taste identical to the active supplements
|
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)
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.
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in muscle function
Time Frame: 6 months
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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
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6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in muscle fatigue
Time Frame: 6 months
|
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
|
6 months
|
Change in general fatigue
Time Frame: 6 months
|
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.
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6 months
|
Change in quality of life
Time Frame: 6 months
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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.
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6 months
|
Change in physical function
Time Frame: 6 months
|
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.
|
6 months
|
Change in physical function
Time Frame: 6 months
|
Change in physical function will be determined by the change in the vertical jump achieved, measured in centimeters
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6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Brian Feldman, MD, MSc, The Hospital for Sick Children
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 6, 2021
Primary Completion (Actual)
March 5, 2024
Study Completion (Actual)
March 5, 2024
Study Registration Dates
First Submitted
February 6, 2020
First Submitted That Met QC Criteria
February 25, 2020
First Posted (Actual)
February 26, 2020
Study Record Updates
Last Update Posted (Actual)
March 22, 2024
Last Update Submitted That Met QC Criteria
March 20, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1000062314
- HC6-24-c228771 (Other Identifier: Health Canada)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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