Ignite Creation Date:
2024-05-06 @ 7:03 AM
Last Modification Date:
2024-10-26 @ 11:43 AM
Study NCT ID:
NCT02454309
Status:
UNKNOWN
Last Update Posted:
2016-06-01
First Post:
2015-05-22
Brief Title:
Cranberry for the Prevention of Urinary Tract Infections
Sponsor:
University of British Columbia
Organization:
University of British Columbia
Study Overview
Official Title:
A Randomised Double-blind Placebo Controlled Trial Evaluating the Effectiveness of a Cranberry Concentrate CranrichTM in Preventing Recurrent Urinary Tract Infections in Adult Women
Status:
UNKNOWN
Status Verified Date:
2016-05
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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 phonedtexted 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None