Cranberry for the Prevention of Urinary Tract Infections
A Randomised, Double-blind, Placebo Controlled Trial Evaluating the Effectiveness of a Cranberry Concentrate (CranrichTM) in Preventing Recurrent Urinary Tract Infections in Adult Women
1 other identifier
interventional
150
1 country
1
Brief Summary
This study aims to determine whether a cranberry concentrate reduces recurrent urinary tract infections (UTIs) in women. Approximately 150 adult women will be recruited to participate in this study. Subjects will be randomized to either the cranberry supplement or placebo treatment for 12 months. Subjects and investigators will be blinded to which supplement they are taking.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jul 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 22, 2015
CompletedFirst Posted
Study publicly available on registry
May 27, 2015
CompletedStudy Start
First participant enrolled
July 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2017
CompletedJune 1, 2016
May 1, 2016
1.4 years
May 22, 2015
May 30, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Number of urinary tract infections
12 months
Study Arms (2)
Cranberry concentrate
EXPERIMENTALEach capsule contains 500 mg of cranberry powder at a concentration ratio of 36:1 (36 grams of cranberries equals 1 gram of concentrate)
Placebo
PLACEBO COMPARATORA capsule containing control formulation
Interventions
Eligibility Criteria
You may qualify if:
- Females who have had at least 2 clinical-diagnosed symptomatic UTIs in the year preceding
- Can communicate in English
You may not qualify if:
- Current UTI
- Pregnant or breastfeeding or planning a pregnancy in the next 12 months
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The University of British Columbia
Vancouver, British Columbia, V6T 1Z4, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 22, 2015
First Posted
May 27, 2015
Study Start
July 1, 2015
Primary Completion
December 1, 2016
Study Completion
March 1, 2017
Last Updated
June 1, 2016
Record last verified: 2016-05