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

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: NCT00100061
Recruitment Status : Unknown
Verified March 2013 by National Center for Complementary and Integrative Health (NCCIH).
Recruitment status was:  Active, not recruiting
First Posted : December 23, 2004
Last Update Posted : March 12, 2013
Sponsor:
Collaborator:
Office of Dietary Supplements (ODS)
Information provided by (Responsible Party):
National Center for Complementary and Integrative Health (NCCIH)

Tracking Information
First Submitted Date  ICMJE December 22, 2004
First Posted Date  ICMJE December 23, 2004
Last Update Posted Date March 12, 2013
Study Start Date  ICMJE May 2007
Estimated Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 21, 2011)
  • Minimum dose of cranberry-containing product necessary to achieve a 30% prophylaxis of UTIs in women with recurrent UTIs [ Time Frame: end of study ]
    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 ]
    comparison of UTI occurrence
  • Whether proanthocyanidin concentration in the urine correlates with UTI prophylaxis [ Time Frame: end of study ]
    recurrence of UTI and lab results
Original Primary Outcome Measures  ICMJE
 (submitted: June 23, 2005)
  • Minimum dose of cranberry-containing product necessary to achieve a 30% prophylaxis of UTIs in women with recurrent UTIs
  • Whether the degree of UTI prophylaxis is related to the dose of cranberry-containing product (dose response curve)
  • Whether proanthocyanidin concentration in the urine correlates with UTI prophylaxis
Change History Complete list of historical versions of study NCT00100061 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Cranberry-Containing Products in Women With Recurrent Urinary Tract Infections (UTIs)
Official Title  ICMJE Dose Response to Cranberry of Women With Recurrent UTIs
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Urinary Tract Infection
Intervention  ICMJE
  • Drug: Cranberry juice
    liquid juice taken daily
  • Dietary Supplement: Cranberry Juice
    Taken orally
  • Dietary Supplement: Placebo cranberry juice
    Placebo comparitor
Study Arms  ICMJE
  • Active Comparator: Cranberry Juice
    Cranberry Juice provided by Ocean Spray
    Interventions:
    • Drug: Cranberry juice
    • Dietary Supplement: Cranberry Juice
  • Placebo Comparator: Placebo cranberry juice
    Taken orally
    Intervention: Dietary Supplement: Placebo cranberry juice
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 Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 23, 2005)
350
Original Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2013
Estimated Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 19 Years and older   (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 NCT00100061
Other Study ID Numbers  ICMJE R01AT002090-01( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party National Center for Complementary and Integrative Health (NCCIH)
Study Sponsor  ICMJE National Center for Complementary and Integrative Health (NCCIH)
Collaborators  ICMJE Office of Dietary Supplements (ODS)
Investigators  ICMJE
Principal Investigator: Lynn Stothers, MD Bladder Care Centre, University of British Columbia
PRS Account National Center for Complementary and Integrative Health (NCCIH)
Verification Date March 2013

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