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

May 13, 2016 updated by: Uppsala University

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

3

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Uppsala, Sweden, 75185
        • Dept of Rehabilitation Medicine, University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo capsule
Dietary supplement: Cranberry capsules
Cranberry capsules, 550mg, or placebo capsules, two capsules three times daily during in-patient rehabilitation
Experimental: Cranberry capsule
Dietary supplement: Cranberry capsules
Cranberry capsules, 550mg, or placebo capsules, two capsules three times daily during in-patient rehabilitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of symptomatic urinary tract infections per patient per month during in-patient post acute rehabilitation
Time Frame: At end of study
At end of study

Secondary Outcome Measures

Outcome Measure
Time Frame
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
At end of Study
Patient's experience of urinary symptoms in the absence of symptomatic urinary tract infection.
Time Frame: At end of study
At end of study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uppsala University

Investigators

  • Principal Investigator: Alison K Godbolt, MbChB MD, University hospital Uppsala

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

February 19, 2010

First Submitted That Met QC Criteria

March 2, 2010

First Posted (Estimate)

March 3, 2010

Study Record Updates

Last Update Posted (Estimate)

May 16, 2016

Last Update Submitted That Met QC Criteria

May 13, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009/280

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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