The Effect of Creatine Supplementation on Muscle Function in Childhood Myositis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02267005
|The Hospital for Sick Children|
|Toronto, Ontario, Canada, M5G 1X8|