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Effects of Cranberry-Containing Products in Women With Recurrent Urinary Tract Infections (UTIs)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Office of Dietary Supplements (ODS)
Information provided by (Responsible Party):
National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:
NCT00100061
First received: December 22, 2004
Last updated: March 11, 2013
Last verified: March 2013
History of Changes
  Purpose

The purpose of this study is to determine the role of cranberry-containing products in preventing urinary tract infections (UTIs).


Condition Intervention Phase
Urinary Tract Infection
 Drug: Cranberry juice
Dietary Supplement: Cranberry Juice
Dietary Supplement: Placebo cranberry juice
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: Dose Response to Cranberry of Women With Recurrent UTIs

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Center for Complementary and Alternative Medicine (NCCAM):

Primary Outcome Measures:
  • Minimum dose of cranberry-containing product necessary to achieve a 30% prophylaxis of UTIs in women with recurrent UTIs [ Time Frame: end of study ] [ Designated as safety issue: No ]
    recurrence of UTI

  • Whether the degree of UTI prophylaxis is related to the dose of cranberry-containing product (dose response curve) [ Time Frame: end of study ] [ Designated as safety issue: No ]
    comparison of UTI occurrence

  • Whether proanthocyanidin concentration in the urine correlates with UTI prophylaxis [ Time Frame: end of study ] [ Designated as safety issue: No ]
    recurrence of UTI and lab results


Estimated Enrollment: 350
Study Start Date: May 2007
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Cranberry Juice
Cranberry Juice provided by Ocean Spray
 Drug: Cranberry juice
liquid juice taken daily
Dietary Supplement: Cranberry Juice
Taken orally
Placebo Comparator: Placebo cranberry juice
Taken orally
 Dietary Supplement: Placebo cranberry juice
Placebo comparitor

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.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00100061

Locations
Canada, British Columbia
Bladder Care Centre, University of British Columbia
Vancouver, British Columbia, Canada, V6T 2B5
Sponsors and Collaborators
National Center for Complementary and Alternative Medicine (NCCAM)
Office of Dietary Supplements (ODS)
Investigators
Principal Investigator: Lynn Stothers, MD Bladder Care Centre, University of British Columbia
  More Information

No publications provided

Responsible Party: National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier: NCT00100061     History of Changes
Other Study ID Numbers: R01 AT002090-01
Study First Received: December 22, 2004
Last Updated: March 11, 2013
Health Authority: Canada: Health Canada
United States: Federal Government
United States: Food and Drug Administration

Keywords provided by National Center for Complementary and Alternative Medicine (NCCAM):
Cranberry
Vaccinium macrocarpon

Additional relevant MeSH terms:
Urinary Tract Infections
Infection
Urologic Diseases

ClinicalTrials.gov processed this record on May 23, 2013