NCT01079169

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 19, 2010

Completed
10 days until next milestone

Study Start

First participant enrolled

March 1, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 3, 2010

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

May 16, 2016

Status Verified

May 1, 2016

Enrollment Period

2 years

First QC Date

February 19, 2010

Last Update Submit

May 13, 2016

Conditions

Spinal Cord InjuryUrinary Tract InfectionRehabilitation

Keywords

urinary tract infectionpreventionrehabilitationspinal cord injury

Outcome Measures

Primary Outcomes (1)

  • Number of symptomatic urinary tract infections per patient per month during in-patient post acute rehabilitation

    At end of study

Secondary Outcomes (2)

  • 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

Study Arms (2)

Cranberry capsule

EXPERIMENTAL
Dietary Supplement: Cranberry capsules

Placebo capsule

PLACEBO COMPARATOR
Dietary Supplement: Cranberry capsules

Interventions

Cranberry capsulesDIETARY_SUPPLEMENT

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

Cranberry capsulePlacebo capsule

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Previously essentially healthy
  • Newly acquired spinal cord injury, T12 level or higher
  • Receiving in-patient care on the rehabilitation ward.
  • Expected admission duration \>= 4 weeks
  • years old or older

You may not qualify if:

  • 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
  • Severe head injury with impairment of cognitive function
  • Allergy to cranberry
  • Renal failure
  • Warfarin (Coumarin) treatment with unstable INR
  • Current symptomatic urinary tract infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept of Rehabilitation Medicine, University Hospital

Uppsala, 75185, Sweden

Location

Related Publications (2)

  • 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.

    PMID: 37947276DERIVED

  • 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.

    PMID: 37068952DERIVED

MeSH Terms

Conditions

Spinal Cord InjuriesUrinary Tract Infections

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and InjuriesInfectionsUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Alison K Godbolt, MbChB MD

    University Hospital Uppsala

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 19, 2010

First Posted

March 3, 2010

Study Start

March 1, 2010

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

May 16, 2016

Record last verified: 2016-05

Locations

SE(1)