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Trial record 1 of 1 for:    NCT02267005
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The Effect of Creatine Supplementation on Muscle Function in Childhood Myositis

This study is currently recruiting participants.
See Contacts and Locations
Verified October 2015 by Brian Feldman, The Hospital for Sick Children
Sponsor:
Information provided by (Responsible Party):
Brian Feldman, The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT02267005
First received: October 1, 2014
Last updated: October 20, 2015
Last verified: October 2015
  Purpose
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 Intervention
Juvenile Dermatomyositis Dietary Supplement: Creapure Dietary Supplement: Glucose Tablet

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: The Effect of Creatine Supplementation on Muscle Function in Childhood Myositis

Resource links provided by NLM:


Further study details as provided by Brian Feldman, The Hospital for Sick Children:

Primary Outcome Measures:
  • Muscle function [ Time Frame: 6 months ]
    Will be determined by mean power output using a Wingate cycle ergometer protocol


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 12
Study Start Date: March 2015
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02267005

Contacts
Contact: Brian Feldman, MD MSc 416-813-5828 brian.feldman@sickkids.ca
Contact: Saunya Dover, MSc 416-813-7712 saunya.dover@sickkids.ca

Locations
Canada, Ontario
The Hospital for Sick Children Recruiting
Toronto, Ontario, Canada, M5G 1X8
Contact: Brian M Feldman, MD MSc    416-813-5825    brian.feldman@sickkids.ca   
Contact: Saunya Dover, MSc    416-813-7712    saunya.dover@sickkids.ca   
Principal Investigator: Brian M Feldman, MD MSc         
Sub-Investigator: Samantha Stephens, MSc, PhD(c)         
Sub-Investigator: Greg Wells, PhD         
Sub-Investigator: Andreas Schulze, MD         
Sub-Investigator: Ingrid Tein, MD         
Sub-Investigator: Jane Schneiderman, PhD         
Sub-Investigator: Deborah Levy, MD MSc         
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     History of Changes
Other Study ID Numbers: 1000041466
Study First Received: October 1, 2014
Last Updated: October 20, 2015

Additional relevant MeSH terms:
Dermatomyositis
Myositis
Polymyositis
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Connective Tissue Diseases
Skin Diseases

ClinicalTrials.gov processed this record on June 21, 2017