The Effect of Creatine Supplementation on Muscle Function in Childhood Myositis

This project will bring together a multidisciplinary team of pediatric rheumatologists, neurologists, metabolic geneticists and exercise physiologists to determine the effect of creatine (CR) supplementation on muscle function and muscle metabolism in children with Dermatomyositis (DM). The investigators propose using well-established exercise testing techniques as well as new, powerful exercise imaging protocols in order to better delineate the effects of CR on muscle pathophysiology in a non-invasive way. Evidence from this study will provide information regarding the effect of creatine supplementation on muscle function in DM. Improvements in muscle function and fatigue through CR use may also contribute to an improvement in quality of life and have significant clinical implications for the treatment of children with DM.

Study Overview

• Status: Completed
• Conditions: Juvenile Dermatomyositis
• Intervention / Treatment: Dietary supplement: Creapure; Dietary supplement: Glucose Tablet

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 1X8
      • The Hospital for Sick Children

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Ages 7 to 18 years
• Diagnosis of probable JDM (onset <16 years) according to Bohan and Peter criteria
• Subjects on a stable course of medication (unlikely to change over study treatment period as determined by the treating physician)
• Minimum height of 132.5cm

Exclusion Criteria:

• Subjects newly diagnosed with 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 baseline visit screening lab values
• Subjects who are currently pregnant or planning to become pregnant within the study period
• Subjects who are shorter than 132.5cm

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment; patients on this arm will be treated with creapure supplements	Dietary supplement: Creapure; Patients will be prescribed a creapure supplement by weight, to be taken 3x/day for the duration of the trial. They will be randomized to an active product start time using a multiple baseline design.; Other Names: ultrapure creatine monohydrate
Placebo Comparator: Placebo; patients on this arm will be given a placebo glucose tablet supplement	Dietary supplement: Glucose Tablet; Patients will be prescribed the placebo supplement by weight, to be taken 3x/day for the duration of the trial. They will be randomized to an active product start time using a multiple baseline design.; Other Names: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Muscle function	Will be determined by mean power output using a Wingate cycle ergometer protocol	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Muscle metabolism	The effects of creatine supplementation on key metabolites responsible for proper energy shuttling in healthy muscle will be measured at rest and using exercise protocols in subjects with P-MRS.	6 months
Quality of life	Both overall and health-related quality of life will be measured at each study visit with the Quality of My Life scale.	6 months
Disease Activity	Will be measured using the International Myositis Assessment and Clinical Studies Group (IMACS) before and after creatine supplementation	6 months
Muscle Strength	Will be estimated at each study visit from a maximal jump test and hand grip strength.	6 months
Fatigue	Will be determined using the PedsQL fatigue module which has been validated for use in children with fibromyalgia and rheumatic disease.	6 months
Adherence	This will be assessed based on a positive blood plasma and urine tests for creatine use over the course of the study period, amount of medication remaining and through self-reports using study diaries.	6 months

Collaborators and Investigators

• Sponsor: The Hospital for Sick Children

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Actual): May 1, 2017
• Study Completion (Actual): May 1, 2017

Study Registration Dates

• First Submitted: October 1, 2014
• First Submitted That Met QC Criteria: October 16, 2014
• First Posted (Estimate): October 17, 2014

Study Record Updates

• Last Update Posted (Actual): May 11, 2018
• Last Update Submitted That Met QC Criteria: May 10, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Skin Diseases; Musculoskeletal Diseases; Connective Tissue Diseases; Muscular Diseases; Neuromuscular Diseases; Polymyositis; Myositis; Dermatomyositis
• Other Study ID Numbers: 1000041466