Ignite Creation Date:
2025-12-24 @ 11:10 PM
Ignite Modification Date:
2026-01-01 @ 5:24 AM
Study NCT ID:
NCT01079169
Status:
TERMINATED
Last Update Posted:
2016-05-16
First Post:
2010-02-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Cranberry Capsules on Urinary Infection Rates in Spinal Cord Injured Patients During Post Acute Rehabilitation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013119', 'term': 'Spinal Cord Injuries'}, {'id': 'D014552', 'term': 'Urinary Tract Infections'}], 'ancestors': [{'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3}}, 'statusModule': {'whyStopped': 'Terminated early due to recruitment difficulties', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-13', 'studyFirstSubmitDate': '2010-02-19', 'studyFirstSubmitQcDate': '2010-03-02', 'lastUpdatePostDateStruct': {'date': '2016-05-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-03-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of symptomatic urinary tract infections per patient per month during in-patient post acute rehabilitation', 'timeFrame': 'At end of study'}], 'secondaryOutcomes': [{'measure': 'Percentage of in-patient rehabilitation days on which patients were unable to participate in active rehabilitation due to urinary tract infection.', 'timeFrame': 'At end of Study'}, {'measure': "Patient's experience of urinary symptoms in the absence of symptomatic urinary tract infection.", 'timeFrame': 'At end of study'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['urinary tract infection', 'prevention', 'rehabilitation', 'spinal cord injury'], 'conditions': ['Spinal Cord Injury', 'Urinary Tract Infection', 'Rehabilitation']}, 'referencesModule': {'references': [{'pmid': '37947276', 'type': 'DERIVED', 'citation': 'Williams G, Stothart CI, Hahn D, Stephens JH, Craig JC, Hodson EM. Cranberries for preventing urinary tract infections. Cochrane Database Syst Rev. 2023 Nov 10;11(11):CD001321. doi: 10.1002/14651858.CD001321.pub7.'}, {'pmid': '37068952', 'type': 'DERIVED', 'citation': 'Williams G, Hahn D, Stephens JH, Craig JC, Hodson EM. Cranberries for preventing urinary tract infections. Cochrane Database Syst Rev. 2023 Apr 17;4(4):CD001321. doi: 10.1002/14651858.CD001321.pub6.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to establish whether cranberry capsules reduce rates of urinary tract infections during initial rehabilitation immediately after spinal cord injury.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Previously essentially healthy\n2. Newly acquired spinal cord injury, T12 level or higher\n3. Receiving in-patient care on the rehabilitation ward.\n4. Expected admission duration \\>= 4 weeks\n5. 16 years old or older\n\nExclusion Criteria:\n\n1. Current or previous disorder that increases the risk of urinary tract infection including diabetes, urological disorder, previous operation on urinary tracts or kidneys, immune dysfunction\n2. Severe head injury with impairment of cognitive function\n3. Allergy to cranberry\n4. Renal failure\n5. Warfarin (Coumarin) treatment with unstable INR\n6. Current symptomatic urinary tract infection'}, 'identificationModule': {'nctId': 'NCT01079169', 'briefTitle': 'Effect of Cranberry Capsules on Urinary Infection Rates in Spinal Cord Injured Patients During Post Acute Rehabilitation', 'organization': {'class': 'OTHER', 'fullName': 'Uppsala University'}, 'officialTitle': 'Evaluation of the Effect of Cranberry Capsules on the Occurrence of Urinary Tract Infections During Post-acute Rehabilitation of Spinal Cord Injured Patients', 'orgStudyIdInfo': {'id': '2009/280'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cranberry capsule', 'interventionNames': ['Dietary Supplement: Cranberry capsules']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo capsule', 'interventionNames': ['Dietary Supplement: Cranberry capsules']}], 'interventions': [{'name': 'Cranberry capsules', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Cranberry capsules, 550mg, or placebo capsules, two capsules three times daily during in-patient rehabilitation', 'armGroupLabels': ['Cranberry capsule', 'Placebo capsule']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75185', 'city': 'Uppsala', 'country': 'Sweden', 'facility': 'Dept of Rehabilitation Medicine, University Hospital', 'geoPoint': {'lat': 59.85882, 'lon': 17.63889}}], 'overallOfficials': [{'name': 'Alison K Godbolt, MbChB MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Uppsala'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Uppsala University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}