Clinical Trial: The Effect of Creatine Supplementation on Muscle Function in Childhood Myositis

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: The Effect of Creatine Supplementation on Muscle Function in Childhood Myositis

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.

Detailed Summary:
Sponsor: The Hospital for Sick Children

Current Primary Outcome: Muscle function [ Time Frame: 6 months ]

Will be determined by mean power output using a Wingate cycle ergometer protocol


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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.


Original Secondary Outcome: Same as current

Information By: The Hospital for Sick Children

Dates:
Date Received: October 1, 2014
Date Started: March 2015
Date Completion: December 2016
Last Updated: October 20, 2015
Last Verified: October 2015