The Effect of Creatine Supplementation on Muscle Function in Childhood Myositis
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|ClinicalTrials.gov Identifier: NCT02267005|
Recruitment Status : Completed
First Posted : October 17, 2014
Last Update Posted : May 11, 2018
|Condition or disease||Intervention/treatment||Phase|
|Juvenile Dermatomyositis||Dietary Supplement: Creapure Dietary Supplement: Glucose Tablet||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||The Effect of Creatine Supplementation on Muscle Function in Childhood Myositis|
|Study Start Date :||March 2015|
|Actual Primary Completion Date :||May 2017|
|Actual Study Completion Date :||May 2017|
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 Name: 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 Name: Placebo
- Muscle function [ Time Frame: 6 months ]Will be determined by mean power output using a Wingate cycle ergometer protocol
- Muscle metabolism [ Time Frame: 6 months ]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.
- Quality of life [ Time Frame: 6 months ]Both overall and health-related quality of life will be measured at each study visit with the Quality of My Life scale.
- Disease Activity [ Time Frame: 6 months ]Will be measured using the International Myositis Assessment and Clinical Studies Group (IMACS) before and after creatine supplementation
- Muscle Strength [ Time Frame: 6 months ]Will be estimated at each study visit from a maximal jump test and hand grip strength.
- Fatigue [ Time Frame: 6 months ]Will be determined using the PedsQL fatigue module which has been validated for use in children with fibromyalgia and rheumatic disease.
- Adherence [ Time Frame: 6 months ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02267005
|The Hospital for Sick Children|
|Toronto, Ontario, Canada, M5G 1X8|