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Effect of Cranberry Capsules on Urinary Infection Rates in Spinal Cord Injured Patients During Post Acute Rehabilitation

This study has been terminated.
(Terminated early due to recruitment difficulties)
Sponsor:
Information provided by:
Uppsala University
ClinicalTrials.gov Identifier:
NCT01079169
First received: February 19, 2010
Last updated: February 8, 2012
Last verified: January 2010
History of Changes

February 19, 2010
February 8, 2012
March 2010
March 2013   (final data collection date for primary outcome measure)
Number of symptomatic urinary tract infections per patient per month during in-patient post acute rehabilitation [ Time Frame: At end of study ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01079169 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • Patient's experience of urinary symptoms in the absence of symptomatic urinary tract infection. [ Time Frame: At end of study ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Effect of Cranberry Capsules on Urinary Infection Rates in Spinal Cord Injured Patients During Post Acute Rehabilitation
Evaluation of the Effect of Cranberry Capsules on the Occurrence of Urinary Tract Infections During Post-acute Rehabilitation of Spinal Cord Injured Patients

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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
  • Spinal Cord Injury
  • Urinary Tract Infection
  • Rehabilitation
Dietary Supplement: Cranberry capsules
Cranberry capsules, 550mg, or placebo capsules, two capsules three times daily during in-patient rehabilitation
  • Experimental: Cranberry capsule
    Intervention: Dietary Supplement: Cranberry capsules
  • Placebo Comparator: Placebo capsule
    Intervention: Dietary Supplement: Cranberry capsules
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
3
Not Provided
March 2013   (final data collection date for primary outcome measure)

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
Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT01079169
2009/280
No
Dr Alison Godbolt, Rehabilitation Medicine, Uppsala University Hospital
Uppsala University
Not Provided
Principal Investigator: Alison K Godbolt, MbChB MD University Hospital Uppsala
Uppsala University
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP