The Effect of Creatine Supplementation on Muscle Function in Childhood Myositis

Juvenile Dermatomyositis Clinical Trial

Official title:

The Effect of Creatine Supplementation on Muscle Function in Childhood Myositis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02267005
• Other study ID #: 1000041466
• Status: Completed
• Phase: N/A
• Start date: March 2015
• Est. completion date: May 2017

Study information

• Verified date: May 2018
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Dermatomyositis
• Juvenile Dermatomyositis
• Myositis

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Muscle function	Will be determined by mean power output using a Wingate cycle ergometer protocol	6 months
Secondary	Muscle metabolism	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.	6 months
Secondary	Quality of life	Both overall and health-related quality of life will be measured at each study visit with the Quality of My Life scale.	6 months
Secondary	Disease Activity	Will be measured using the International Myositis Assessment and Clinical Studies Group (IMACS) before and after creatine supplementation	6 months
Secondary	Muscle Strength	Will be estimated at each study visit from a maximal jump test and hand grip strength.	6 months
Secondary	Fatigue	Will be determined using the PedsQL fatigue module which has been validated for use in children with fibromyalgia and rheumatic disease.	6 months
Secondary	Adherence	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.	6 months