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Cranberry on Urinary Tract Infections

NCT ID: NCT01881165

Last Updated: 2014-12-16

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

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2016-03-31

Brief Summary

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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

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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.

Conditions

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Urinary Tract Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Cranberry

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

Group Type EXPERIMENTAL

Cranberry

Intervention Type DRUG

Placebo

A capsule containing control formulation

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Cranberry

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of British Columbia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tim Green, PhD

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

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The University of British Columbia

Vancouver, British Columbia, Canada

Site Status

Countries

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Canada

Other Identifiers

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H13-01491

Identifier Type: -

Identifier Source: org_study_id