This trial is active, not recruiting.

Condition urinary tract infection
Treatments cranberry juice, placebo cranberry juice
Phase phase 2
Sponsor National Center for Complementary and Alternative Medicine (NCCAM)
Collaborator Office of Dietary Supplements (ODS)
Start date May 2007
End date July 2013
Trial size 350 participants
Trial identifier NCT00100061, R01 AT002090-01


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

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose prevention
(Active Comparator)
Cranberry Juice provided by Ocean Spray
cranberry juice
liquid juice taken daily
cranberry juice
Taken orally
(Placebo Comparator)
Taken orally
placebo cranberry juice
Placebo comparitor

Primary Outcomes

Minimum dose of cranberry-containing product necessary to achieve a 30% prophylaxis of UTIs in women with recurrent UTIs
time frame: end of study
Whether the degree of UTI prophylaxis is related to the dose of cranberry-containing product (dose response curve)
time frame: end of study
Whether proanthocyanidin concentration in the urine correlates with UTI prophylaxis
time frame: end of study

Eligibility Criteria

Female participants at least 19 years old.

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

Additional Information

Official title Dose Response to Cranberry of Women With Recurrent UTIs
Principal investigator Lynn Stothers, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2013.
Information provided to ClinicalTrials.gov by National Center for Complementary and Alternative Medicine (NCCAM).