NCT00100061

Brief Summary

The purpose of this study is to determine the role of cranberry-containing products in preventing urinary tract infections (UTIs).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
350

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started May 2007

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

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

December 22, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 23, 2004

Completed
2.4 years until next milestone

Study Start

First participant enrolled

May 1, 2007

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

March 12, 2013

Status Verified

March 1, 2013

Enrollment Period

6.2 years

First QC Date

December 22, 2004

Last Update Submit

March 11, 2013

Conditions

Urinary Tract Infection

Keywords

CranberryVaccinium macrocarpon

Outcome Measures

Primary Outcomes (3)

  • Minimum dose of cranberry-containing product necessary to achieve a 30% prophylaxis of UTIs in women with recurrent UTIs

    recurrence of UTI

    end of study

  • Whether the degree of UTI prophylaxis is related to the dose of cranberry-containing product (dose response curve)

    comparison of UTI occurrence

    end of study

  • Whether proanthocyanidin concentration in the urine correlates with UTI prophylaxis

    recurrence of UTI and lab results

    end of study

Study Arms (2)

Cranberry Juice

ACTIVE COMPARATOR

Cranberry Juice provided by Ocean Spray

Drug: Cranberry juiceDietary Supplement: Cranberry Juice

Placebo cranberry juice

PLACEBO COMPARATOR

Taken orally

Dietary Supplement: Placebo cranberry juice

Interventions

Cranberry JuiceDRUG

liquid juice taken daily

Cranberry Juice
Placebo cranberry juiceDIETARY_SUPPLEMENT

Placebo comparitor

Placebo cranberry juice

Eligibility Criteria

Age19 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • At least two UTIs in the year prior to study entry
  • Willing to use acceptable methods of contraception
  • Willing to refrain from consuming other forms of cranberry supplementation

You may not qualify if:

  • Current UTI
  • Allergy to cranberry-containing products
  • Active urinary stone disease
  • Insulin-dependent diabetes
  • Immunosuppressive disease
  • Current corticosteroid use
  • Intermittent or indwelling catheterization
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bladder Care Centre, University of British Columbia

Vancouver, British Columbia, V6T 2B5, Canada

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

Urinary Tract Infections

Condition Hierarchy (Ancestors)

InfectionsUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Lynn Stothers, MD

    Bladder Care Centre, University of British Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 22, 2004

First Posted

December 23, 2004

Study Start

May 1, 2007

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

March 12, 2013

Record last verified: 2013-03

Locations

CA(1)