A Phase 4 interventional study of Cranberry concentrate and Placebo in Urinary Tract Infection, sponsored by University of British Columbia. Status unknown at 1 site in Canada. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-06-01.
Sponsored by University of British Columbia · Phase 4, Interventional, and Prevention
This study aims to determine whether a cranberry concentrate reduces recurrent urinary tract infections (UTIs) in women. Approximately 150 adult women will be recruited to participate in this study. Subjects will be randomized to either the cranberry supplement or placebo treatment for 12 months. Subjects and investigators will be blinded to which supplement they are taking.
Participants will be randomized to receive either a cranberry concentrate or placebo. Participants, study staff and investigators will remain blinded until after the dataset has been cleaned. At the baseline visit participants will be instructed to consume the assigned supplement twice daily for 12 consecutive months. A calendar will be provided to record compliance, recurrent UTIs and any side effects. Participants will be phoned/texted each month to encourage participation. Additional study visits will be completed at 3 months, 6 months and 9 months to collect information on recurrent UTIs and adherence. A urine sample will be collected from participants at each visit to test for pregnancy and the presence of an undetected UTI. Supplements will be distributed at each visit for the following 3-month study period and the last bottle of unused product returned. At the 12-month visit, participants will complete an end-line questionnaire and return their supplement bottle in addition to the calendar and side effect diary. If participants withdraw from the study, they will be encouraged to return at 12 months to complete a survey to allow for intent-to-treat analysis.
779 studies on the registry are indexed under Urinary Tract Infections; 132 are open to participants now.
This study's planned enrollment of 150 is above the median of 130 across 544 interventional studies indexed under Urinary Tract Infections.
Browse Urinary Tract Infections studies →University of British Columbia is the lead sponsor of 1,335 studies on the registry; 256 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.
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Exclusion Criteria:
Each capsule contains 500 mg of cranberry powder at a concentration ratio of 36:1 (36 grams of cranberries equals 1 gram of concentrate)
Dietary Supplement: Cranberry concentrate
A capsule containing control formulation
Dietary Supplement: Placebo
Also known as: Cranrich (™)
Number of urinary tract infections
Time frame: 12 months
This study is status unknown, as verified in May 2016. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Cranberry juice
University of British Columbia →