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Exercise, Creatine and Coenzyme Q10 for Childhood Myositis

Primary Purpose

Myositis, Juvenile

Status

Recruiting

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

creatine monohydrate

ubiquinol

glucose tablet

gel capsule

Exercise

About this trial

This is an interventional supportive care trial for Myositis, Juvenile

Eligibility Criteria

7 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Ages 7 to 18 years
Diagnosis of juvenile dermatomyositis (JDM) 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 JDM 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

Sites / Locations

The Hospital for Sick ChildrenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Treatment

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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.

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.

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.

Change in physical function

Change in physical function will be determined by the change in the vertical jump achieved, measured in centimeters

Full Information

NCT ID

NCT04286178

First Posted

February 6, 2020

Last Updated

October 6, 2023

Sponsor

The Hospital for Sick Children

1. Study Identification

Unique Protocol Identification Number

NCT04286178

Brief Title

Exercise, Creatine and Coenzyme Q10 for Childhood Myositis

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Recruiting

Study Start Date

April 6, 2021 (Actual)

Primary Completion Date

March 31, 2024 (Anticipated)

Study Completion Date

March 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

The Hospital for Sick Children

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Myositis, Juvenile

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Model Description

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

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Treatment

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

creatine monohydrate

Intervention Description

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

Intervention Name(s)

ubiquinol

Other Intervention Name(s)

coenzyme Q10

Intervention Description

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

Intervention Name(s)

glucose tablet

Intervention Description

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

Intervention Name(s)

gel capsule

Intervention Description

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

Behavioral

Intervention Name(s)

Exercise

Intervention Description

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)

Primary Outcome Measure Information:

Title

Change in muscle function

Description

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

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Change in muscle fatigue

Description

Time Frame

6 months

Title

Change in general fatigue

Description

Time Frame

6 months

Title

Change in quality of life

Description

Time Frame

6 months

Title

Change in physical function

Description

Time Frame

6 months

Title

Change in physical function

Description

Change in physical function will be determined by the change in the vertical jump achieved, measured in centimeters

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

7 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Brian Feldman, MD, MSc

Phone

416-813-7707

brian.feldman@sickkids.ca

First Name & Middle Initial & Last Name or Official Title & Degree

Kayla Baker, B.Sc.

Phone

416-813-7654

Ext

409338

kayla.baker@sickkids.ca

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Brian Feldman, MD, MSc

Organizational Affiliation

The Hospital for Sick Children

Official's Role

Principal Investigator

Facility Information:

Facility Name

The Hospital for Sick Children

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 1X8

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Brian M Feldman, MD, MSc

Phone

416-813-7707

brian.feldman@sickkids.ca

First Name & Middle Initial & Last Name & Degree

Kayla Baker, BSc

Phone

416-813-7654

Ext

409338

kayla.baker@sickkids.ca

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Exercise, Creatine and Coenzyme Q10 for Childhood Myositis

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