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Completed

NCT Number: NCT02267005

The Effect of Creatine Supplementation on Muscle Function in Childhood Myositis

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.

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Key information

Conditions

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

Age range

7 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Creapure

Dietary Supplement

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 names: ultrapure creatine monohydrate

glucose tablet

Dietary Supplement

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 names: Placebo

Primary outcomes

  1. Muscle function

    Time frame: 6 months

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

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Registry information

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Oct 17, 2014
Registry last updated
May 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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