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Cranberry on Urinary Tract Infections

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Recruitment Status : Withdrawn (Sponsor declined funding)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

Tracking Information
First Submitted Date  ICMJE June 17, 2013
First Posted Date  ICMJE June 19, 2013
Last Update Posted Date December 16, 2014
Study Start Date  ICMJE September 2014
Estimated Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History Complete list of historical versions of study NCT01881165 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 17, 2013)
Side effects [ Time Frame: 12 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cranberry on Urinary Tract Infections
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Urinary Tract Infection
Intervention  ICMJE
  • Drug: Cranberry
  • Drug: Placebo
Study Arms  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: December 12, 2014)
0
Original Estimated Enrollment  ICMJE
 (submitted: June 17, 2013)
150
Estimated Study Completion Date  ICMJE March 2016
Estimated Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01881165
Other Study ID Numbers  ICMJE H13-01491
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of British Columbia
Study Sponsor  ICMJE University of British Columbia
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Tim Green, PhD University of British Columbia
PRS Account University of British Columbia
Verification Date December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP