NCT01881165

Cranberry on Urinary Tract Infections

A Randomized, Double-blind, Placebo Controlled Trial Evaluating the Effectiveness of a Cranberry Concentrate in Preventing Recurrent Urinary Tract Infections in Adult Women

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of British Columbia · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Accepted

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.

Detailed description

Participants will attend their first study visit at a clinic at UBC. They will be randomized to the cranberry capsule or placebo. Participants will be instructed to consume the assigned supplement for the next 12 months. A calendar will be provided to record compliance and recurrent UTI. Participants will also record any side effects. They will be phoned each month to encourage participation and adherence. At 8 weeks and 6 months, they will be asked to return to the clinic to complete a midline questionnaire which will ask about any recurrent UTIs experienced. More supplements will be provided at their 6-month visit. At 12 months, participants will return to the clinic to complete an endline questionnaire. They will return any leftover supplements, calendar and side effect diary. If participants withdraw from the study, they will still be encouraged to return at 12 months to complete the survey to allow for intent-to-treat analysis.

Conditions

• Urinary Tract Infection

Interventions

Type	Name	Description
DRUG	Cranberry
DRUG	Placebo

Timeline

• Start date: 2014-09-01
• Primary completion: 2015-12-01
• Completion: 2016-03-01
• First posted: 2013-06-19
• Last updated: 2014-12-16

Locations

1 site across 1 country: Canada