Cranberry on Urinary Tract Infections

• ClinicalTrials.gov Identifier: NCT01881165
• Recruitment Status: Withdrawn
• First Posted: June 19, 2013
• Last Update Posted: December 16, 2014
• Sponsor: University of British Columbia
• Information provided by (Responsible Party): University of British Columbia

Tracking Information

• First Submitted Date: June 17, 2013
• First Posted Date: June 19, 2013
• Last Update Posted Date: December 16, 2014
• Study Start Date: September 2014
• Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 17, 2013)

Number of urinary tract infections [ Time Frame: 12 months ]

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

• Original Primary Outcome Measures: Same as current
• Change History: Complete list of historical versions of study NCT01881165 on ClinicalTrials.gov Archive Site
• Current Secondary Outcome Measures (submitted: June 17, 2013): Side effects [ Time Frame: 12 months ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Cranberry on Urinary Tract Infections
• 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
• 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.
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Prevention
• Condition: Urinary Tract Infection

Intervention

• Drug: Cranberry
• Drug: Placebo

Study Arms

• 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).
  Intervention: Drug: Cranberry
• Placebo Comparator: Placebo
  A capsule containing control formulation
  Intervention: Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Withdrawn
• Actual Enrollment (submitted: December 12, 2014): 0
• Original Estimated Enrollment (submitted: June 17, 2013): 150
• Estimated Study Completion Date: March 2016
• Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada

Administrative Information

• NCT Number: NCT01881165
• Other Study ID Numbers: H13-01491
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: University of British Columbia
• Study Sponsor: University of British Columbia
• Collaborators: Not Provided

Investigators

• Principal Investigator: Tim Green, PhD; University of British Columbia

• PRS Account: University of British Columbia
• Verification Date: December 2014