Cranberry on Urinary Tract Infections

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified May 2014 by University of British Columbia
Sponsor:
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01881165
First received: June 17, 2013
Last updated: May 26, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Urinary Tract Infection
Drug: Cranberry
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Number of urinary tract infections [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 150
Study Start Date: September 2014
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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).
Drug: Cranberry
Placebo Comparator: Placebo
A capsule containing control formulation
Drug: Placebo

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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01881165

Contacts
Contact: Tim Green, PhD tigreen@mail.ubc.ca

Locations
Canada, British Columbia
The University of British Columbia Not yet recruiting
Vancouver, British Columbia, Canada, V6T 1Z4
Principal Investigator: Tim Green, PhD         
Sponsors and Collaborators
University of British Columbia
Investigators
Principal Investigator: Tim Green, PhD University of British Columbia
  More Information

No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01881165     History of Changes
Other Study ID Numbers: H13-01491
Study First Received: June 17, 2013
Last Updated: May 26, 2014
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Communicable Diseases
Infection
Urinary Tract Infections
Urologic Diseases

ClinicalTrials.gov processed this record on October 30, 2014