Exercise, Creatine and Coenzyme Q10 for Childhood Myositis

Myositis, Juvenile Clinical Trial

Official title:

The Effects of Exercise, Creatine, and Coenzyme Q10 Supplementation on Muscle Function in Children With Myositis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04286178
• Other study ID #: 1000062314
• Secondary ID: HC6-24-c228771
• Status: Completed
• Phase: N/A
• Start date: April 6, 2021
• Est. completion date: March 5, 2024

Study information

• Verified date: March 2024
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: March 5, 2024
• Est. primary completion date: March 5, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Dermatomyositis
• Myositis
• Myositis, Juvenile

Intervention

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.
• 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.
• 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.
• 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)

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in muscle fatigue	Change in muscle fatigue will be determined by the change in the fatigue index during the wingate test. Fatigue index is a percentage, and is calculated as follows: [(Peak Power - End Power)/Peak Power] x100	6 months
Secondary	Change in general fatigue	Change in fatigue will be determined by the change in the Pediatric Quality of Life - Fatigue Module scores (PedsQL-Fatigue). This measure is scored on a scale of 0-100 with 100 representing the least amount of fatigue.	6 months
Secondary	Change in quality of life	Change in quality of life will be determined by the change in the Quality of My Life questionnaire scores. Quality of my Life consists of 3 visual analog scales each scored out of 10. Higher scores indicate better quality of life.	6 months
Secondary	Change in physical function	Change in physical function will be determined by the change in the hand grip strength, measured using a hand dynamometer. Three attempts will be given per hand, and the maximum grip strength achieved (in kg displaced) will be recorded for each hand.	6 months
Secondary	Change in physical function	Change in physical function will be determined by the change in the vertical jump achieved, measured in centimeters	6 months