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

NCT ID: NCT01079169

Last Updated: 2016-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2012-03-31

Brief Summary

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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

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Conditions

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Spinal Cord Injury Urinary Tract Infection Rehabilitation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Cranberry capsule

Group Type EXPERIMENTAL

Cranberry capsules

Intervention Type DIETARY_SUPPLEMENT

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

Placebo capsule

Group Type PLACEBO_COMPARATOR

Cranberry capsules

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Cranberry capsules

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Uppsala University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alison K Godbolt, MbChB MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Uppsala

Locations

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Dept of Rehabilitation Medicine, University Hospital

Uppsala, , Sweden

Site Status

Countries

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Sweden

References

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Williams G, Stothart CI, Hahn D, Stephens JH, Craig JC, Hodson EM. Cranberries for preventing urinary tract infections. Cochrane Database Syst Rev. 2023 Nov 10;11(11):CD001321. doi: 10.1002/14651858.CD001321.pub7.

Reference Type DERIVED
PMID: 37947276 (View on PubMed)

Williams G, Hahn D, Stephens JH, Craig JC, Hodson EM. Cranberries for preventing urinary tract infections. Cochrane Database Syst Rev. 2023 Apr 17;4(4):CD001321. doi: 10.1002/14651858.CD001321.pub6.

Reference Type DERIVED
PMID: 37068952 (View on PubMed)

Other Identifiers

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2009/280

Identifier Type: -

Identifier Source: org_study_id

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