The Effect of Creatine Supplementation on Muscle Function in Childhood Myositis

• ClinicalTrials.gov Identifier: NCT02267005
• Recruitment Status: Completed
• First Posted: October 17, 2014
• Last Update Posted: May 11, 2018
• Sponsor: The Hospital for Sick Children
• Information provided by (Responsible Party): Brian Feldman, The Hospital for Sick Children

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Juvenile Dermatomyositis	Dietary Supplement: Creapure; Dietary Supplement: Glucose Tablet	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 13 participants
• Allocation: Randomized
• 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

Arms and Interventions

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 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

Outcome Measures

Primary Outcome Measures :

1. Muscle function [ Time Frame: 6 months ]
   Will be determined by mean power output using a Wingate cycle ergometer protocol

Secondary Outcome Measures :

1. 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.
2. 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.
3. Disease Activity [ Time Frame: 6 months ]
   Will be measured using the International Myositis Assessment and Clinical Studies Group (IMACS) before and after creatine supplementation
4. Muscle Strength [ Time Frame: 6 months ]
   Will be estimated at each study visit from a maximal jump test and hand grip strength.
5. 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.
6. 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.

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

Canada, Ontario

The Hospital for Sick Children

Toronto, Ontario, Canada, M5G 1X8

Sponsors and Collaborators

The Hospital for Sick Children

More Information

• Responsible Party: Brian Feldman, Division Head, Rheumatology / Sr Scientist, The Hospital for Sick Children
• ClinicalTrials.gov Identifier: NCT02267005
• Other Study ID Numbers: 1000041466
• First Posted: October 17, 2014
• Last Update Posted: May 11, 2018
• Last Verified: May 2018

Additional relevant MeSH terms:

Dermatomyositis; Myositis; Polymyositis; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Connective Tissue Diseases; Skin Diseases