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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Enrollment
15
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.
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.
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)
The Hospital for Sick Children
Toronto, Ontario, Canada
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
Time frame: 6 months
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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 6 months
Change in physical function
Change in physical function will be determined by the change in the vertical jump achieved, measured in centimeters
Time frame: 6 months
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