Exercise, Creatine and Coenzyme Q10 for Childhood Myositis

NCT04286178 | Completed

• 2 other identifiers: 1000062314HC6-24-c228771
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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

  6 months

Secondary Outcomes (5)

• Change in muscle fatigue

  6 months

• Change in general fatigue

  6 months

• Change in quality of life

  6 months

• Change in physical function

  6 months

• Change in physical function

  6 months

Study Arms (2)

Treatment

EXPERIMENTAL

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

Dietary Supplement: creatine monohydrate; Dietary Supplement: ubiquinol; Behavioral: Exercise

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: glucose tablet; Dietary Supplement: gel capsule; Behavioral: Exercise

Interventions

creatine monohydrate 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.

Treatment

ubiquinol 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.

Also known as: coenzyme Q10

Treatment

glucose tablet 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.

Placebo

gel capsule 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.

Placebo

Exercise 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; Treatment

Eligibility Criteria

• Age: 7 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

MeSH Terms

Conditions

Dermatomyositis

Interventions

Creatine; ubiquinol; coenzyme Q10; Glucose; Gels; Exercise

Condition Hierarchy (Ancestors)

Polymyositis; Myositis; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Intervention Hierarchy (Ancestors)

Guanidines; Amidines; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins; Hexoses; Monosaccharides; Sugars; Carbohydrates; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Brian Feldman, MD, MSc

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Division Head, Division of Rheumatology

Model Details: This study will be a double-blinded, placebo-controlled, randomized, multiple baseline design (MBD) where each subject will be randomly allocated a start time for the active supplements

Study Record Dates

• First Submitted: February 6, 2020
• First Posted: February 26, 2020
• Study Start: April 6, 2021
• Primary Completion: March 5, 2024
• Study Completion: March 5, 2024
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)