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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02267005 |
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Date of registration:
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01/10/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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The Effect of Creatine Supplementation on Muscle Function in Childhood Myositis
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Scientific title:
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The Effect of Creatine Supplementation on Muscle Function in Childhood Myositis |
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Date of first enrolment:
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March 2015 |
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Target sample size:
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13 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02267005 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Supportive Care. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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Canada
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Key inclusion & exclusion criteria
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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
Age minimum:
7 Years
Age maximum:
18 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Juvenile Dermatomyositis
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Intervention(s)
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Dietary Supplement: Glucose Tablet
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Dietary Supplement: Creapure
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Primary Outcome(s)
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Muscle function
[Time Frame: 6 months]
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Secondary Outcome(s)
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Quality of life
[Time Frame: 6 months]
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Muscle Strength
[Time Frame: 6 months]
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Adherence
[Time Frame: 6 months]
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Muscle metabolism
[Time Frame: 6 months]
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Disease Activity
[Time Frame: 6 months]
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Fatigue
[Time Frame: 6 months]
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Secondary ID(s)
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1000041466
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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