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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
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

December 22, 2004
March 11, 2013
May 2007
July 2013   (final data collection date for primary outcome measure)
  • 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
  • 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
Complete list of historical versions of study NCT00100061 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Effects of Cranberry-Containing Products in Women With Recurrent Urinary Tract Infections (UTIs)
Dose Response to Cranberry of Women With Recurrent UTIs

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

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Urinary Tract Infection
  • Drug: Cranberry juice
    liquid juice taken daily
  • Dietary Supplement: Cranberry Juice
    Taken orally
  • Dietary Supplement: Placebo cranberry juice
    Placebo comparitor
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
350
July 2013
July 2013   (final data collection date for primary outcome measure)

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
Female
19 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00100061
R01 AT002090-01
Yes
National Center for Complementary and Alternative Medicine (NCCAM)
National Center for Complementary and Alternative Medicine (NCCAM)
Office of Dietary Supplements (ODS)
Principal Investigator: Lynn Stothers, MD Bladder Care Centre, University of British Columbia
National Center for Complementary and Alternative Medicine (NCCAM)
March 2013

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