The Effect of Creatine Supplementation on Muscle Function in Childhood Myositis
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02267005 |
Recruitment Status :
Completed
First Posted : October 17, 2014
Last Update Posted : May 11, 2018
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Juvenile Dermatomyositis | Dietary Supplement: Creapure Dietary Supplement: Glucose Tablet | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 13 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Supportive Care |
Official Title: | The Effect of Creatine Supplementation on Muscle Function in Childhood Myositis |
Study Start Date : | March 2015 |
Actual Primary Completion Date : | May 2017 |
Actual Study Completion Date : | May 2017 |

Arm | Intervention/treatment |
---|---|
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 |
- Muscle function [ Time Frame: 6 months ]Will be determined by mean power output using a Wingate cycle ergometer protocol
- 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.

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, Learn About Clinical Studies.
Ages Eligible for Study: | 7 Years to 18 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02267005
Canada, Ontario | |
The Hospital for Sick Children | |
Toronto, Ontario, Canada, M5G 1X8 |
Responsible Party: | Brian Feldman, Division Head, Rheumatology / Sr Scientist, The Hospital for Sick Children |
ClinicalTrials.gov Identifier: | NCT02267005 |
Other Study ID Numbers: |
1000041466 |
First Posted: | October 17, 2014 Key Record Dates |
Last Update Posted: | May 11, 2018 |
Last Verified: | May 2018 |
Dermatomyositis Myositis Polymyositis Muscular Diseases Musculoskeletal Diseases |
Neuromuscular Diseases Nervous System Diseases Connective Tissue Diseases Skin Diseases |