ClinicalTrials.gov
ClinicalTrials.gov Menu

Cranberry for the Prevention of Urinary Tract Infections

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02454309
Recruitment Status : Unknown
Verified May 2016 by University of British Columbia.
Recruitment status was:  Recruiting
First Posted : May 27, 2015
Last Update Posted : June 1, 2016
Sponsor:
Information provided by (Responsible Party):
University of British Columbia

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.

Condition or disease Intervention/treatment Phase
Urinary Tract Infection Dietary Supplement: Cranberry concentrate Dietary Supplement: Placebo Phase 4

Detailed Description:
Participants will be randomized to receive either a cranberry concentrate or placebo. Participants, study staff and investigators will remain blinded until after the dataset has been cleaned. At the baseline visit participants will be instructed to consume the assigned supplement twice daily for 12 consecutive months. A calendar will be provided to record compliance, recurrent UTIs and any side effects. Participants will be phoned/texted each month to encourage participation. Additional study visits will be completed at 3 months, 6 months and 9 months to collect information on recurrent UTIs and adherence. A urine sample will be collected from participants at each visit to test for pregnancy and the presence of an undetected UTI. Supplements will be distributed at each visit for the following 3-month study period and the last bottle of unused product returned. At the 12-month visit, participants will complete an end-line questionnaire and return their supplement bottle in addition to the calendar and side effect diary. If participants withdraw from the study, they will be encouraged to return at 12 months to complete a survey to allow for intent-to-treat analysis.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: A Randomised, Double-blind, Placebo Controlled Trial Evaluating the Effectiveness of a Cranberry Concentrate (CranrichTM) in Preventing Recurrent Urinary Tract Infections in Adult Women
Study Start Date : July 2015
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : March 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cranberry concentrate
Each capsule contains 500 mg of cranberry powder at a concentration ratio of 36:1 (36 grams of cranberries equals 1 gram of concentrate)
Dietary Supplement: Cranberry concentrate
Other Name: Cranrich (™)

Placebo Comparator: Placebo
A capsule containing control formulation
Dietary Supplement: Placebo



Primary Outcome Measures :
  1. Number of urinary tract infections [ Time Frame: 12 months ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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
  • Can communicate in English

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02454309


Contacts
Contact: Sarah J Harvey, MSc 6047542245 sarah.harvey@ubc.ca

Locations
Canada, British Columbia
The University of British Columbia Recruiting
Vancouver, British Columbia, Canada, V6T 1Z4
Principal Investigator: Tim Green, PhD         
Sponsors and Collaborators
University of British Columbia

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT02454309     History of Changes
Other Study ID Numbers: H15-00892
First Posted: May 27, 2015    Key Record Dates
Last Update Posted: June 1, 2016
Last Verified: May 2016

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