Effects of Cranberry-Containing Products in Women With Recurrent Urinary Tract Infections (UTIs)
Primary Purpose
Urinary Tract Infection
Status
Unknown status
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Cranberry juice
Cranberry Juice
Placebo cranberry juice
Sponsored by
About this trial
This is an interventional prevention trial for Urinary Tract Infection focused on measuring Cranberry, Vaccinium macrocarpon
Eligibility Criteria
Inclusion Criteria: At least two UTIs in the year prior to study entry Willing to use acceptable methods of contraception Willing to refrain from consuming other forms of cranberry supplementation Exclusion Criteria: Current UTI Allergy to cranberry-containing products Active urinary stone disease Insulin-dependent diabetes Immunosuppressive disease Current corticosteroid use Intermittent or indwelling catheterization Pregnancy
Sites / Locations
- Bladder Care Centre, University of British Columbia
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Cranberry Juice
Placebo cranberry juice
Arm Description
Cranberry Juice provided by Ocean Spray
Taken orally
Outcomes
Primary Outcome Measures
Minimum dose of cranberry-containing product necessary to achieve a 30% prophylaxis of UTIs in women with recurrent UTIs
recurrence of UTI
Whether the degree of UTI prophylaxis is related to the dose of cranberry-containing product (dose response curve)
comparison of UTI occurrence
Whether proanthocyanidin concentration in the urine correlates with UTI prophylaxis
recurrence of UTI and lab results
Secondary Outcome Measures
Full Information
NCT ID
NCT00100061
First Posted
December 22, 2004
Last Updated
March 11, 2013
Sponsor
National Center for Complementary and Integrative Health (NCCIH)
Collaborators
Office of Dietary Supplements (ODS)
1. Study Identification
Unique Protocol Identification Number
NCT00100061
Brief Title
Effects of Cranberry-Containing Products in Women With Recurrent Urinary Tract Infections (UTIs)
Official Title
Dose Response to Cranberry of Women With Recurrent UTIs
Study Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Unknown status
Study Start Date
May 2007 (undefined)
Primary Completion Date
July 2013 (Anticipated)
Study Completion Date
July 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Center for Complementary and Integrative Health (NCCIH)
Collaborators
Office of Dietary Supplements (ODS)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to determine the role of cranberry-containing products in preventing urinary tract infections (UTIs).
Detailed Description
Although cranberry-containing products are commonly taken to prevent UTIs and other urinary symptoms, an optimally effective dose has not been established, and the chemicals responsible for the UTI-preventing properties in cranberry-containing products have yet to be determined. This study will determine the minimum dose of cranberry-containing product necessary to prevent UTIs, the effectiveness of cranberry-containing products in fighting different strains of E. coli, and the long-term effects of cranberry-containing product consumption. This study will also determine whether plant pigments called proanthocyanidins influence the UTI-preventing properties of cranberry-containing products.
This study will last 2 years. Participants will be randomly assigned to receive varying doses of either cranberry-containing products or placebo for 1 year. Some participants will receive cranberry or placebo supplement tablets; others will receive cranberry juice or a placebo beverage. Clinic visits will occur every 2 months; urine collection will occur at each visit. Some participants will be asked to collect 24-hour urine samples every 8 weeks and provide urine samples on Days 1, 3, 5 and 7.
Laboratory tests will be used to assess participants during the study. A 3-day course of antibiotics will be provided to participants developing a UTI during the course of the study. Telephone interview follow-up at 6 and 12 months after the study will determine whether cranberry-containing product use has continued and whether UTIs have recurred.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Tract Infection
Keywords
Cranberry, Vaccinium macrocarpon
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
350 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cranberry Juice
Arm Type
Active Comparator
Arm Description
Cranberry Juice provided by Ocean Spray
Arm Title
Placebo cranberry juice
Arm Type
Placebo Comparator
Arm Description
Taken orally
Intervention Type
Drug
Intervention Name(s)
Cranberry juice
Intervention Description
liquid juice taken daily
Intervention Type
Dietary Supplement
Intervention Name(s)
Cranberry Juice
Intervention Description
Taken orally
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo cranberry juice
Intervention Description
Placebo comparitor
Primary Outcome Measure Information:
Title
Minimum dose of cranberry-containing product necessary to achieve a 30% prophylaxis of UTIs in women with recurrent UTIs
Description
recurrence of UTI
Time Frame
end of study
Title
Whether the degree of UTI prophylaxis is related to the dose of cranberry-containing product (dose response curve)
Description
comparison of UTI occurrence
Time Frame
end of study
Title
Whether proanthocyanidin concentration in the urine correlates with UTI prophylaxis
Description
recurrence of UTI and lab results
Time Frame
end of study
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
At least two UTIs in the year prior to study entry
Willing to use acceptable methods of contraception
Willing to refrain from consuming other forms of cranberry supplementation
Exclusion Criteria:
Current UTI
Allergy to cranberry-containing products
Active urinary stone disease
Insulin-dependent diabetes
Immunosuppressive disease
Current corticosteroid use
Intermittent or indwelling catheterization
Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lynn Stothers, MD
Organizational Affiliation
Bladder Care Centre, University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bladder Care Centre, University of British Columbia
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6T 2B5
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Effects of Cranberry-Containing Products in Women With Recurrent Urinary Tract Infections (UTIs)
We'll reach out to this number within 24 hrs