Exercise, Creatine and Coenzyme Q10 for Childhood Myositis

Last updated: March 20, 2024
Sponsor: The Hospital for Sick Children
Overall Status: Completed

Phase

N/A

Condition

Idiopathic Inflammatory Myopathies

Lupus

Myositis

Treatment

ubiquinol

gel capsule

creatine monohydrate

Clinical Study ID

NCT04286178
1000062314
HC6-24-c228771
  • Ages 7-18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Ages 7 to 18 years
  • Diagnosis of juvenile idiopathic inflammatory myopathy (JIIM) according to the 2017European 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 treatmentperiod as determined by treating physician)
  • Minimum height of 132.5cm (required to fit on the cycle ergometer)

Exclusion

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 theexercise testing
  • Subjects with impaired kidney function as determined from pre-baseline visit screeninglab 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 studyperiod

Study Design

Total Participants: 15
Treatment Group(s): 5
Primary Treatment: ubiquinol
Phase:
Study Start date:
April 06, 2021
Estimated Completion Date:
March 05, 2024

Connect with a study center

  • The Hospital for Sick Children

    Toronto, Ontario M5G 1X8
    Canada

    Site Not Available

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