Exercise, Creatine and Coenzyme Q10 for Childhood Myositis

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. 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

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)

Sponsors & Collaborators

• The Hospital for Sick Children

  lead OTHER

Principal Investigators

• Brian Feldman, MD, MSc · The Hospital for Sick Children

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE

Model

CROSSOVER

Eligibility

Min Age

7 Years

Max Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-04-06

Primary Completion

2024-03-05

Completion

2024-03-05

Countries

• Canada

Study Locations