Juvenile DermatomyositisNCT02267005
The Effect of Creatine Supplementation on Muscle Function in Childhood Myositis
A study testing Creapure and Glucose Tablet in people with Juvenile Dermatomyositis, run by The Hospital for Sick Children at 1 site in Canada.
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). Read more about this study
- Who is it for?
- Ages 7 to 18 years
- Conditions the study is for
- Juvenile Dermatomyositis
- What is being tested?
- Creapure and Glucose Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2015to May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Juvenile Dermatomyositis
- Being tested
- Creapure, Glucose Tablet
- Medical subject headings
- Dermatomyositis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CreapureDietary supplement
Also called ultrapure creatine monohydrate
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 TabletDietary supplement
Also called Placebo
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | patients on this arm will be treated with creapure supplements Receives: Dietary Supplement: Creapure |
| Placebo | Placebo comparator | patients on this arm will be given a placebo glucose tablet supplement Receives: Dietary Supplement: Glucose Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle function
Will be determined by mean power output using a Wingate cycle ergometer protocol
Measured: 6 months
Secondary outcomes (6)
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.
Measured: 6 months
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.
Measured: 6 months
Disease Activity
Will be measured using the International Myositis Assessment and Clinical Studies Group (IMACS) before and after creatine supplementation
Measured: 6 months
Muscle Strength
Will be estimated at each study visit from a maximal jump test and hand grip strength.
Measured: 6 months
Fatigue
Will be determined using the PedsQL fatigue module which has been validated for use in children with fibromyalgia and rheumatic disease.
Measured: 6 months
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2014 (estimated)
- Study startMar 2015
- Primary completionMay 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Juvenile DermatomyositisStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brian Feldman, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02267005
- Sponsor's protocol ID
- 1000041466
- Status last verified
- May 2018
- First submitted
- 1 Oct 2014
- Last updated
- 11 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Creatine Supplementation on Muscle Function in Childhood Myositis
- ClinicalTrials.gov ID
- NCT02267005
- Acronym / sponsor ID
- 1000041466
- Conditions
- Juvenile Dermatomyositis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 17 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Dietary Supplement: Creapurepatients on this arm will be treated with creapure supplements |
| Placebo | Placebo comparator | Dietary Supplement: Glucose Tabletpatients on this arm will be given a placebo glucose tablet supplement |
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CreapureAlso: ultrapure creatine monohydratePatients 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. | Dietary supplement | Treatment |
| Glucose TabletAlso: PlaceboPatients 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. | Dietary supplement | Placebo |
Primary outcome
Muscle function
Time frame: 6 months
Will be determined by mean power output using a Wingate cycle ergometer protocol
6 secondary outcomes
Muscle metabolism
Time frame: 6 months
Quality of life
Time frame: 6 months
Disease Activity
Time frame: 6 months
Muscle Strength
Time frame: 6 months
Fatigue
Time frame: 6 months
Adherence
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2018.
Related trials for Juvenile Dermatomyositis
RecruitingPhase 2
FAST for DM - Fatty Acid Supplementation Trial (FAST) for Dermatomyositis (DM)
Dermatomyositis (DM), Juvenile Dermatomyositis (JDM)
RecruitingObservational study
Natural History of Inflammatory Muscle Diseases
Inflammation In Skeletal Muscle
RecruitingObservational study
Environmental Risk Factors for the Anti-synthetase Syndrome
Myositis, Dermatomyositis
RecruitingPhase 2/3
RESET-Myositis: An Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Subjects With Active Idiopathic Inflammatory Myopathy or Juvenile Idiopathic Inflammatory Myopathy
Idiopathic Inflammatory Myopathy, Dermatomyositis
RecruitingObservational study
Adult and Juvenile Myositis
Dermatomyositis, Polymyositis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Creapure and Glucose Tablet in people with Juvenile Dermatomyositis, run by The Hospital for Sick Children at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle function (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2018.