Ignite Creation Date:
2025-12-25 @ 1:09 AM
Ignite Modification Date:
2026-02-24 @ 4:11 AM
Study NCT ID:
NCT01798693
Status:
TERMINATED
Last Update Posted:
2015-05-13
First Post:
2013-01-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nutritional Supplementation Effects on Rehabilitation Outcomes in Rotator Cuff Pathology
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C008315', 'term': 'maltodextrin'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}}, 'statusModule': {'whyStopped': 'Poor subject compliance and inadequate recruitment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-11', 'studyFirstSubmitDate': '2013-01-18', 'studyFirstSubmitQcDate': '2013-02-21', 'lastUpdatePostDateStruct': {'date': '2015-05-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-02-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in shoulder function, pain, strength and range of motion', 'timeFrame': 'Change from baseline to four, six, and twelve weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Shoulder', 'Supplement', 'Amino Acids', 'Collagen', 'Standard of Care'], 'conditions': ['Rotator Cuff/Shoulder Structure and Function']}, 'descriptionModule': {'briefSummary': 'Rotator Injury:\n\n* Strength/range of Motion\n* ASES, VAS', 'detailedDescription': 'The addition of a nutritional therapy to a standardized physical therapy program, may expedite recovery from shoulder injury. An attractive feature of this approach is the development of an efficacious adjunct therapy that is economically superior to traditional therapy modalities and logistically feasible.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Between 18-65 years old\n* Diagnosed with rotator cuff injury that will not be treated surgically\n\nExclusion Criteria:\n\n* Have received a previous injection therapy (platelet-rich plasma or corticosteroid injection) within previous 6 months\n* Have used the following supplements in the previous 2 weeks: Vitamin C or D, or protein supplements\n* Have poorly controlled type I or type II diabetes (HgB A1C \\> 9.5%) or renal insufficiency (GFR \\< 60 ml/min).\n* Have an inability to participate in rehabilitation exercises.\n* Are diagnosed with arthritis, rheumatoid arthritis, or any other autoimmune or rheumatologic disease\n* Have musculoskeletal pathology in a neighboring joint or structure\n* Have an allergy to any component of the nutritional supplement\n* Are consuming warfarin'}, 'identificationModule': {'nctId': 'NCT01798693', 'briefTitle': 'Nutritional Supplementation Effects on Rehabilitation Outcomes in Rotator Cuff Pathology', 'organization': {'class': 'OTHER', 'fullName': 'University of North Carolina, Chapel Hill'}, 'officialTitle': 'Nutritional Supplementation Effects on Rehabilitation Outcomes in Rotator Cuff Pathology', 'orgStudyIdInfo': {'id': 'ORB-12-2374'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo (maltodextrin)', 'description': 'Maltodextrin', 'interventionNames': ['Dietary Supplement: Placebo (maltodextrin)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Multi-Nutrient Blend', 'description': 'Blend of vitamins, minerals, and amino acids, given twice daily', 'interventionNames': ['Dietary Supplement: Multi-nutrient Blend']}], 'interventions': [{'name': 'Placebo (maltodextrin)', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Placebo (maltodextrin)']}, {'name': 'Multi-nutrient Blend', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Multi-Nutrient Blend']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'UNC Orthopedics and Exercise and Sport Medicine', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of North Carolina, Chapel Hill', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Abbie Smith-Ryan, PhD', 'investigatorAffiliation': 'University of North Carolina, Chapel Hill'}}}}