Cranberry on Urinary Tract Infections

NCT01881165 | Withdrawn Phase 4

• 1 other identifier: H13-01491
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to determine whether a cranberry concentrate reduces recurrent urinary tract infections (UTIs) in women who consume it. About 150 adult women will participate in this study. Subjects will be randomized (like flipping a coin) to take either cranberry capsule or a placebo for 12 months. We expect cranberry supplement to have better results than the placebo. Subjects will not know which supplement they are taking. The primary outcome is the number of UTIs over 12 months.

Conditions

Urinary Tract Infection

Outcome Measures

Primary Outcomes (1)

• Number of urinary tract infections

  The number of symptomatic UTIs over 12 months (defined by self-report as having one or more of the following symptoms: dysuria, frequency, urgency, hematuria, supra-pubic pressure or fever), the proportion of participants with at least 1 symptomatic UTI, the median time to the first UTI

  12 months

Secondary Outcomes (1)

• Side effects

  12 months

Study Arms (2)

Cranberry

EXPERIMENTAL

Each capsule contains 500 mg of cranberry powder at a concentration ratio of 36:1 (36 grams of cranberries equals 1 gram of concentrate).

Drug: Cranberry

Placebo

PLACEBO COMPARATOR

A capsule containing control formulation

Drug: Placebo

Interventions

Cranberry DRUG

Cranberry

Placebo DRUG

Placebo

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Females who have had at least 2 clinical-diagnosed symptomatic UTIs in the year preceding
• Are sexually active

You may not qualify if:

• Current UTI
• Pregnant or breastfeeding or planning a pregnancy in the next 12 months
• A known allergy or intolerance to cranberry-containing products
• A history of renal stones and/or renal transplantation
• Any immunosuppressive disease or other medical conditions that could potentially interfere with outcomes
• Current use of corticosteroid, anticoagulant, antidepressants or mood stabilizing medications or other medications that may interact with the supplement
• Intermittent or indwelling catheterization
• Any anatomic abnormalities of the urinary tract
• The use of any antibiotics within 2 weeks before study entry
• The use of any natural health products, including herbs, homeopathic products, or other forms of cranberry supplements within 2 weeks before study entry

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

The University of British Columbia

Vancouver, British Columbia, V6T 1Z4, Canada

Location

MeSH Terms

Conditions

Urinary Tract Infections

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Tim Green, PhD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2013
• First Posted: June 19, 2013
• Study Start: September 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: March 1, 2016
• Last Updated: December 16, 2014

Record last verified: 2014-12

Locations

CA (1)