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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Enrollment
13
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.
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.
The Hospital for Sick Children
Toronto, Ontario, Canada
Muscle function
Will be determined by mean power output using a Wingate cycle ergometer protocol
Time frame: 6 months
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.
Time frame: 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.
Time frame: 6 months
Disease Activity
Will be measured using the International Myositis Assessment and Clinical Studies Group (IMACS) before and after creatine supplementation
Time frame: 6 months
Muscle Strength
Will be estimated at each study visit from a maximal jump test and hand grip strength.
Time frame: 6 months
Fatigue
Will be determined using the PedsQL fatigue module which has been validated for use in children with fibromyalgia and rheumatic disease.
Time frame: 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.
Time frame: 6 months
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