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

Spinal Cord Injury Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01079169
• Other study ID #: 2009/280
• Status: Terminated
• Phase: N/A
• First received: February 19, 2010
• Last updated: May 13, 2016
• Start date: March 2010
• Est. completion date: March 2012

Study information

• Verified date: May 2016
• Source: Uppsala University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: The National Board of Health and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Rehabilitation
• Spinal Cord Injuries
• Spinal Cord Injury
• Urinary Tract Infection
• Urinary Tract Infections

Intervention

Dietary Supplement:
• Cranberry capsules
Cranberry capsules, 550mg, or placebo capsules, two capsules three times daily during in-patient rehabilitation

Locations

Country	Name	City	State
Sweden	Dept of Rehabilitation Medicine, University Hospital	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
Uppsala University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of symptomatic urinary tract infections per patient per month during in-patient post acute rehabilitation		At end of study	No
Secondary	Percentage of in-patient rehabilitation days on which patients were unable to participate in active rehabilitation due to urinary tract infection.		At end of Study	No
Secondary	Patient's experience of urinary symptoms in the absence of symptomatic urinary tract infection.		At end of study	No