Back to resultsEffect of Cranberry Capsules on Urinary Infection Rates in Spinal Cord Injured Patients During Post Acute Rehabilitation
Primary Purpose
Spinal Cord Injury, Urinary Tract Infection, Rehabilitation
Status
Terminated
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Cranberry capsules
Sponsored by
About this trial
This is an interventional prevention trial for Spinal Cord Injury focused on measuring urinary tract infection, prevention, rehabilitation, spinal cord injury
Eligibility Criteria
Inclusion Criteria:
- Previously essentially healthy
- Newly acquired spinal cord injury, T12 level or higher
- Receiving in-patient care on the rehabilitation ward.
- Expected admission duration >= 4 weeks
- 16 years old or older
Exclusion Criteria:
- 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
- Severe head injury with impairment of cognitive function
- Allergy to cranberry
- Renal failure
- Warfarin (Coumarin) treatment with unstable INR
- Current symptomatic urinary tract infection
Sites / Locations
- Dept of Rehabilitation Medicine, University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Cranberry capsule
Placebo capsule
Arm Description
Outcomes
Primary Outcome Measures
Number of symptomatic urinary tract infections per patient per month during in-patient post acute rehabilitation
Secondary Outcome Measures
Percentage of in-patient rehabilitation days on which patients were unable to participate in active rehabilitation due to urinary tract infection.
Patient's experience of urinary symptoms in the absence of symptomatic urinary tract infection.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01079169
Brief Title
Effect of Cranberry Capsules on Urinary Infection Rates in Spinal Cord Injured Patients During Post Acute Rehabilitation
Official Title
Evaluation of the Effect of Cranberry Capsules on the Occurrence of Urinary Tract Infections During Post-acute Rehabilitation of Spinal Cord Injured Patients
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Terminated
Why Stopped
Terminated early due to recruitment difficulties
Study Start Date
March 2010 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Uppsala University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury, Urinary Tract Infection, Rehabilitation
Keywords
urinary tract infection, prevention, rehabilitation, spinal cord injury
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cranberry capsule
Arm Type
Experimental
Arm Title
Placebo capsule
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Cranberry capsules
Intervention Description
Cranberry capsules, 550mg, or placebo capsules, two capsules three times daily during in-patient rehabilitation
Primary Outcome Measure Information:
Title
Number of symptomatic urinary tract infections per patient per month during in-patient post acute rehabilitation
Time Frame
At end of study
Secondary Outcome Measure Information:
Title
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
Title
Patient's experience of urinary symptoms in the absence of symptomatic urinary tract infection.
Time Frame
At end of study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Previously essentially healthy
Newly acquired spinal cord injury, T12 level or higher
Receiving in-patient care on the rehabilitation ward.
Expected admission duration >= 4 weeks
16 years old or older
Exclusion Criteria:
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
Severe head injury with impairment of cognitive function
Allergy to cranberry
Renal failure
Warfarin (Coumarin) treatment with unstable INR
Current symptomatic urinary tract infection
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alison K Godbolt, MbChB MD
Organizational Affiliation
University Hospital Uppsala
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept of Rehabilitation Medicine, University Hospital
City
Uppsala
ZIP/Postal Code
75185
Country
Sweden
12. IPD Sharing Statement
Learn more about this trial
Effect of Cranberry Capsules on Urinary Infection Rates in Spinal Cord Injured Patients During Post Acute Rehabilitation
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