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The Effect of Creatine Supplementation on Muscle Function in Childhood Myositis

T

The Hospital for Sick Children

Status

Completed

Conditions

Juvenile Dermatomyositis

Treatments

Dietary Supplement: Creapure
Dietary Supplement: Glucose Tablet

Study type

Interventional

Funder types

Other

Identifiers

NCT02267005
1000041466

Details and patient eligibility

About

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.

Enrollment

13 patients

Sex

All

Ages

7 to 18 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Quadruple Blind

13 participants in 2 patient groups, including a placebo group

Treatment
Experimental group
Description:
patients on this arm will be treated with creapure supplements
Treatment:
Dietary Supplement: Creapure
Placebo
Placebo Comparator group
Description:
patients on this arm will be given a placebo glucose tablet supplement
Treatment:
Dietary Supplement: Glucose Tablet

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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