Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2026-02-23 @ 11:34 AM
Study NCT ID:
NCT02267005
Status:
COMPLETED
Last Update Posted:
2018-05-11
First Post:
2014-10-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Creatine Supplementation on Muscle Function in Childhood Myositis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003882', 'term': 'Dermatomyositis'}], 'ancestors': [{'id': 'D017285', 'term': 'Polymyositis'}, {'id': 'D009220', 'term': 'Myositis'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005947', 'term': 'Glucose'}], 'ancestors': [{'id': 'D006601', 'term': 'Hexoses'}, {'id': 'D009005', 'term': 'Monosaccharides'}, {'id': 'D000073893', 'term': 'Sugars'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2017-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-10', 'studyFirstSubmitDate': '2014-10-01', 'studyFirstSubmitQcDate': '2014-10-16', 'lastUpdatePostDateStruct': {'date': '2018-05-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-10-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Muscle function', 'timeFrame': '6 months', 'description': 'Will be determined by mean power output using a Wingate cycle ergometer protocol'}], 'secondaryOutcomes': [{'measure': 'Muscle metabolism', 'timeFrame': '6 months', 'description': '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.'}, {'measure': 'Quality of life', 'timeFrame': '6 months', 'description': 'Both overall and health-related quality of life will be measured at each study visit with the Quality of My Life scale.'}, {'measure': 'Disease Activity', 'timeFrame': '6 months', 'description': 'Will be measured using the International Myositis Assessment and Clinical Studies Group (IMACS) before and after creatine supplementation'}, {'measure': 'Muscle Strength', 'timeFrame': '6 months', 'description': 'Will be estimated at each study visit from a maximal jump test and hand grip strength.'}, {'measure': 'Fatigue', 'timeFrame': '6 months', 'description': 'Will be determined using the PedsQL fatigue module which has been validated for use in children with fibromyalgia and rheumatic disease.'}, {'measure': 'Adherence', 'timeFrame': '6 months', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Juvenile Dermatomyositis']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '7 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ages 7 to 18 years\n* Diagnosis of probable JDM (onset \\<16 years) according to Bohan and Peter criteria\n* Subjects on a stable course of medication (unlikely to change over study treatment period as determined by the treating physician)\n* Minimum height of 132.5cm\n\nExclusion Criteria:\n\n* Subjects newly diagnosed with JDM within the previous 6 months\n* Subjects unable to cooperate with study procedures, or too weak to participate in the exercise testing\n* Subjects with impaired kidney function as determined from baseline visit screening lab values\n* Subjects who are currently pregnant or planning to become pregnant within the study period\n* Subjects who are shorter than 132.5cm'}, 'identificationModule': {'nctId': 'NCT02267005', 'briefTitle': 'The Effect of Creatine Supplementation on Muscle Function in Childhood Myositis', 'organization': {'class': 'OTHER', 'fullName': 'The Hospital for Sick Children'}, 'officialTitle': 'The Effect of Creatine Supplementation on Muscle Function in Childhood Myositis', 'orgStudyIdInfo': {'id': '1000041466'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment', 'description': 'patients on this arm will be treated with creapure supplements', 'interventionNames': ['Dietary Supplement: Creapure']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'patients on this arm will be given a placebo glucose tablet supplement', 'interventionNames': ['Dietary Supplement: Glucose Tablet']}], 'interventions': [{'name': 'Creapure', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['ultrapure creatine monohydrate'], 'description': '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.', 'armGroupLabels': ['Treatment']}, {'name': 'Glucose Tablet', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Placebo'], 'description': '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.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5G 1X8', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'The Hospital for Sick Children', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Hospital for Sick Children', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Division Head, Rheumatology / Sr Scientist', 'investigatorFullName': 'Brian Feldman', 'investigatorAffiliation': 'The Hospital for Sick Children'}}}}