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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
  Purpose

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.


Condition Intervention
Spinal Cord Injury
Urinary Tract Infection
Rehabilitation
 Dietary Supplement: Cranberry capsules

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Uppsala University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 3
Study Start Date: March 2010
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cranberry capsule Dietary Supplement: Cranberry capsules
Cranberry capsules, 550mg, or placebo capsules, two capsules three times daily during in-patient rehabilitation
Placebo Comparator: Placebo capsule Dietary Supplement: Cranberry capsules
Cranberry capsules, 550mg, or placebo capsules, two capsules three times daily during in-patient rehabilitation

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01079169

Locations
Sweden
Dept of Rehabilitation Medicine, University Hospital
Uppsala, Sweden, 75185
Sponsors and Collaborators
Uppsala University
Investigators
Principal Investigator: Alison K Godbolt, MbChB MD University Hospital Uppsala
  More Information

No publications provided

Responsible Party: Dr Alison Godbolt, Rehabilitation Medicine, Uppsala University Hospital
ClinicalTrials.gov Identifier: NCT01079169     History of Changes
Other Study ID Numbers: 2009/280
Study First Received: February 19, 2010
Last Updated: February 8, 2012
Health Authority: Sweden: The National Board of Health and Welfare

Keywords provided by Uppsala University:
urinary tract infection
prevention
rehabilitation
spinal cord injury

Additional relevant MeSH terms:
Spinal Cord Injuries
Urinary Tract Infections
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
 Trauma, Nervous System
Wounds and Injuries
Infection
Urologic Diseases

ClinicalTrials.gov processed this record on May 19, 2013