NCT00638170

Brief Summary

The objective of the study is to determine whether recurrences of urinary tract infection in children can be prevented with cranberry juice.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
262

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2001

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

May 1, 2001

Completed
6.9 years until next milestone

First Submitted

Initial submission to the registry

March 10, 2008

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 18, 2008

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
Last Updated

February 16, 2009

Status Verified

January 1, 2008

Enrollment Period

7.8 years

First QC Date

March 10, 2008

Last Update Submit

February 13, 2009

Conditions

Urinary Tract Infections

Keywords

Urinary Tract InfectionsCranberryPrevention

Outcome Measures

Primary Outcomes (1)

  • Occurrence of the first recurrence

    12 months

Secondary Outcomes (1)

  • Total number of UTI episodes and use of antimicrobials

    12 months

Study Arms (2)

A

ACTIVE COMPARATOR

Cranberry juice

Biological: Cranberry juice

B

PLACEBO COMPARATOR

Placebo juice

Biological: Placebo juice

Interventions

Cranberry juiceBIOLOGICAL

5 ml/kg up to 300 ml, 1-2 doses daily for six months

A
Placebo juiceBIOLOGICAL

5 ml/kg up to 300 ml, 1-2 doses daily for six months

B

Eligibility Criteria

Age1 Year - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Urinary Tract Infection 0-2 months priorly

You may not qualify if:

  • Antibiotic Prophylaxis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Oulu

Oulu, 90140, Finland

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

  • Matti Uhari, Professor

    University of Oulu

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 10, 2008

First Posted

March 18, 2008

Study Start

May 1, 2001

Primary Completion

February 1, 2009

Study Completion

February 1, 2009

Last Updated

February 16, 2009

Record last verified: 2008-01

Locations

FI(1)