Exercise, Creatine and Coenzyme Q10 for Childhood Myositis

NACompletedINTERVENTIONAL
Enrollment

15

Participants

Timeline

Start Date

April 6, 2021

Primary Completion Date

March 5, 2024

Study Completion Date

March 5, 2024

Conditions
Myositis, Juvenile
Interventions
DIETARY_SUPPLEMENT

creatine monohydrate

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.

DIETARY_SUPPLEMENT

ubiquinol

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.

DIETARY_SUPPLEMENT

glucose tablet

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.

DIETARY_SUPPLEMENT

gel capsule

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.

BEHAVIORAL

Exercise

"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)"

Trial Locations (1)

M5G 1X8

The Hospital for Sick Children, Toronto

All Listed Sponsors
lead

The Hospital for Sick Children

OTHER

NCT04286178 - Exercise, Creatine and Coenzyme Q10 for Childhood Myositis | Biotech Hunter | Biotech Hunter