The Effect of Creatine Supplementation on Muscle Function in Childhood Myositis

Not Applicable

Completed

• Conditions: Juvenile Dermatomyositis
• Interventions: Dietary Supplement: Creapure; Dietary Supplement: Glucose Tablet

• Registration Number: NCT02267005
• Lead Sponsor: The Hospital for Sick Children

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 Description

Not available

Study Timeline

• Study First Submitted: 2014-10-01
• Study First Submitted QC: 2014-10-16
• Study First Posted: 2014-10-17
• Study Start: 2015-03
• Primary Completion: 2017-05
• Study Completion: 2017-05
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-10
• Last Update Posted: 2018-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment	Creapure	patients on this arm will be treated with creapure supplements
Placebo	Glucose Tablet	patients on this arm will be given a placebo glucose tablet supplement

Primary Outcome Measures

Name	Time	Method
Muscle function	6 months	Will be determined by mean power output using a Wingate cycle ergometer protocol

Secondary Outcome Measures

Name	Time	Method
Muscle metabolism	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	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	6 months	Will be measured using the International Myositis Assessment and Clinical Studies Group (IMACS) before and after creatine supplementation
Muscle Strength	6 months	Will be estimated at each study visit from a maximal jump test and hand grip strength.
Fatigue	6 months	Will be determined using the PedsQL fatigue module which has been validated for use in children with fibromyalgia and rheumatic disease.
Adherence	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.

Trial Locations

Locations (1)

The Hospital for Sick Children; 🇨🇦 Toronto, Ontario, Canada