Exercise, Creatine and Coenzyme Q10 for Childhood Myositis

NCT ID: NCT04286178

Last Updated: 2024-03-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-06
• Study Completion Date: 2024-03-05

Brief Summary

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.

Conditions

Myositis, Juvenile

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

Treatment

patients in this arm will be treated with creatine and coenzyme Q10 supplements

Group Type: EXPERIMENTAL

creatine monohydrate

Intervention Type: DIETARY_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.

ubiquinol

Intervention Type: DIETARY_SUPPLEMENT

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.

Exercise

Intervention Type: BEHAVIORAL

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)

Placebo

patients in this arm will be given placebo supplements that look and taste identical to the active supplements

Group Type: PLACEBO_COMPARATOR

glucose tablet

Intervention Type: DIETARY_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 capsule

Intervention Type: DIETARY_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.

Exercise

Intervention Type: BEHAVIORAL

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)

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DIETARY_SUPPLEMENT

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)

Intervention Type: BEHAVIORAL

Other Intervention Names

coenzyme Q10

Eligibility Criteria

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

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Hospital for Sick Children

OTHER

Sponsor Role: lead

Responsible Party

Brian Feldman

Division Head, Division of Rheumatology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Brian Feldman, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

The Hospital for Sick Children

Locations

The Hospital for Sick Children

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

HC6-24-c228771

Identifier Type: OTHER

Identifier Source: secondary_id

1000062314

Identifier Type: -

Identifier Source: org_study_id