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Main
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Note: This record shows only the 20 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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17 October 2012 |
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Main ID: |
NCT01079169 |
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Date of registration:
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19/02/2010 |
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Primary sponsor: |
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Public title:
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Effect of Cranberry Capsules on Urinary Infection Rates in Spinal Cord Injured Patients During Post Acute Rehabilitation
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Scientific title:
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Evaluation of the Effect of Cranberry Capsules on the Occurrence of Urinary Tract Infections During Post-acute Rehabilitation of Spinal Cord Injured Patients |
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Date of first enrolment:
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March 2010 |
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Target sample size:
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3 |
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Recruitment status: |
Terminated |
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URL:
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http://clinicaltrials.gov/show/NCT01079169 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
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Countries of recruitment
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Sweden
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Contacts
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Name:
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Alison K Godbolt, MbChB MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Hospital Uppsala |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Previously essentially healthy
2. Newly acquired spinal cord injury, T12 level or higher
3. Receiving in-patient care on the rehabilitation ward.
4. Expected admission duration >= 4 weeks
5. 16 years old or older
Exclusion Criteria:
1. 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
2. Severe head injury with impairment of cognitive function
3. Allergy to cranberry
4. Renal failure
5. Warfarin (Coumarin) treatment with unstable INR
6. Current symptomatic urinary tract infection
Age minimum:
16 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Rehabilitation
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Spinal Cord Injury
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Urinary Tract Infection
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Intervention(s)
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Dietary Supplement: Cranberry capsules
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Primary Outcome(s)
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Number of symptomatic urinary tract infections per patient per month during in-patient post acute rehabilitation
[Time Frame: At end of study]
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Secondary Outcome(s)
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Patient's experience of urinary symptoms in the absence of symptomatic urinary tract infection.
[Time Frame: At end of study]
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Percentage of in-patient rehabilitation days on which patients were unable to participate in active rehabilitation due to urinary tract infection.
[Time Frame: At end of Study]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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