Cranberry on Urinary Tract Infections | NCT01881165

Studies
Cranberry on Urinary Tract Infections

NCT01881165

Sponsor

University of British Columbia

Status

Withdrawn

Last Update Posted

Dec 16, 2014Estimated

Enrollment

0Actual

Phase

Phase 4

Conditions

Urinary Tract Infection

Interventions

Cranberry
Placebo

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2014

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Sponsor declined funding

Expanded Access Info

Start Date

Sep 2014

Primary Completion Date

Dec 2015Estimated

Completion Date

Mar 2016Estimated

First Submitted Date

Jun 17, 2013

First Submission Date that Met QC Criteria

Jun 17, 2013

First Posted Date

Jun 19, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 12, 2014

Last Update Posted Date

Dec 16, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cranberry	Experimental	Each capsule contains 500 mg of cranberry powder at a concentration ratio of 36:1 (36 grams of cranberries equals 1 gram of concentrate).	Drug: Cranberry
Placebo	Placebo Comparator	A capsule containing control formulation	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cranberry	Drug		Cranberry
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	12 months

Secondary Outcomes

Measure	Description	Time Frame
Side effects		12 months

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Tim Green, PhD	University of British Columbia	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The University of British Columbia		Vancouver	British Columbia	V6T 1Z4	Canada

Condition Browse Module

MeSH Terms

ID	Term
D014552	Urinary Tract Infections

Ancestor Terms

ID	Term
D007239	Infections
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

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Browse Branches

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