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Cranberry on Urinary Tract Infections

Primary Purpose

Urinary Tract Infection

Status
Withdrawn
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Cranberry
Placebo
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Urinary Tract Infection

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Females who have had at least 2 clinical-diagnosed symptomatic UTIs in the year preceding
  • Are sexually active

Exclusion Criteria:

  • Current UTI
  • Pregnant or breastfeeding or planning a pregnancy in the next 12 months
  • A known allergy or intolerance to cranberry-containing products
  • A history of renal stones and/or renal transplantation
  • Any immunosuppressive disease or other medical conditions that could potentially interfere with outcomes
  • Current use of corticosteroid, anticoagulant, antidepressants or mood stabilizing medications or other medications that may interact with the supplement
  • Intermittent or indwelling catheterization
  • Any anatomic abnormalities of the urinary tract
  • The use of any antibiotics within 2 weeks before study entry
  • The use of any natural health products, including herbs, homeopathic products, or other forms of cranberry supplements within 2 weeks before study entry

Sites / Locations

  • The University of British Columbia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Cranberry

Placebo

Arm Description

Each capsule contains 500 mg of cranberry powder at a concentration ratio of 36:1 (36 grams of cranberries equals 1 gram of concentrate).

A capsule containing control formulation

Outcomes

Primary Outcome Measures

Number of urinary tract infections
The number of symptomatic UTIs over 12 months (defined by self-report as having one or more of the following symptoms: dysuria, frequency, urgency, hematuria, supra-pubic pressure or fever), the proportion of participants with at least 1 symptomatic UTI, the median time to the first UTI

Secondary Outcome Measures

Side effects

Full Information

First Posted
June 17, 2013
Last Updated
December 12, 2014
Sponsor
University of British Columbia
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1. Study Identification

Unique Protocol Identification Number
NCT01881165
Brief Title
Cranberry on Urinary Tract Infections
Official Title
A Randomized, Double-blind, Placebo Controlled Trial Evaluating the Effectiveness of a Cranberry Concentrate in Preventing Recurrent Urinary Tract Infections in Adult Women
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Withdrawn
Why Stopped
Sponsor declined funding
Study Start Date
September 2014 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
March 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of British Columbia

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study aims to determine whether a cranberry concentrate reduces recurrent urinary tract infections (UTIs) in women who consume it. About 150 adult women will participate in this study. Subjects will be randomized (like flipping a coin) to take either cranberry capsule or a placebo for 12 months. We expect cranberry supplement to have better results than the placebo. Subjects will not know which supplement they are taking. The primary outcome is the number of UTIs over 12 months.
Detailed Description
Participants will attend their first study visit at a clinic at UBC. They will be randomized to the cranberry capsule or placebo. Participants will be instructed to consume the assigned supplement for the next 12 months. A calendar will be provided to record compliance and recurrent UTI. Participants will also record any side effects. They will be phoned each month to encourage participation and adherence. At 8 weeks and 6 months, they will be asked to return to the clinic to complete a midline questionnaire which will ask about any recurrent UTIs experienced. More supplements will be provided at their 6-month visit. At 12 months, participants will return to the clinic to complete an endline questionnaire. They will return any leftover supplements, calendar and side effect diary. If participants withdraw from the study, they will still be encouraged to return at 12 months to complete the survey to allow for intent-to-treat analysis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Tract Infection

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cranberry
Arm Type
Experimental
Arm Description
Each capsule contains 500 mg of cranberry powder at a concentration ratio of 36:1 (36 grams of cranberries equals 1 gram of concentrate).
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
A capsule containing control formulation
Intervention Type
Drug
Intervention Name(s)
Cranberry
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Number of urinary tract infections
Description
The number of symptomatic UTIs over 12 months (defined by self-report as having one or more of the following symptoms: dysuria, frequency, urgency, hematuria, supra-pubic pressure or fever), the proportion of participants with at least 1 symptomatic UTI, the median time to the first UTI
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Side effects
Time Frame
12 months

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Females who have had at least 2 clinical-diagnosed symptomatic UTIs in the year preceding Are sexually active Exclusion Criteria: Current UTI Pregnant or breastfeeding or planning a pregnancy in the next 12 months A known allergy or intolerance to cranberry-containing products A history of renal stones and/or renal transplantation Any immunosuppressive disease or other medical conditions that could potentially interfere with outcomes Current use of corticosteroid, anticoagulant, antidepressants or mood stabilizing medications or other medications that may interact with the supplement Intermittent or indwelling catheterization Any anatomic abnormalities of the urinary tract The use of any antibiotics within 2 weeks before study entry The use of any natural health products, including herbs, homeopathic products, or other forms of cranberry supplements within 2 weeks before study entry
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tim Green, PhD
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of British Columbia
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6T 1Z4
Country
Canada

12. IPD Sharing Statement

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Cranberry on Urinary Tract Infections

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