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

Not Applicable

Terminated

• Conditions: Spinal Cord Injury; Urinary Tract Infection; Rehabilitation
• Interventions: Dietary Supplement: Cranberry capsules

• Registration Number: NCT01079169
• Lead Sponsor: Uppsala University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-02-19
• Study Start: 2010-03
• Study First Submitted QC: 2010-03-02
• Study First Posted: 2010-03-03
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-13
• Last Update Posted: 2016-05-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cranberry capsule	Cranberry capsules	-
Placebo capsule	Cranberry capsules	-

Primary Outcome Measures

Name	Time	Method
Number of symptomatic urinary tract infections per patient per month during in-patient post acute rehabilitation	At end of study

Secondary Outcome Measures

Name	Time	Method
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
Patient's experience of urinary symptoms in the absence of symptomatic urinary tract infection.	At end of study

Trial Locations

Locations (1)

Dept of Rehabilitation Medicine, University Hospital; 🇸🇪 Uppsala, Sweden