Ignite Creation Date:
2024-05-06 @ 1:45 AM
Last Modification Date:
2024-10-26 @ 11:08 AM
Study NCT ID:
NCT01881165
Status:
WITHDRAWN
Last Update Posted:
2014-12-16
First Post:
2013-06-17
Brief Title:
Cranberry on Urinary Tract Infections
Sponsor:
University of British Columbia
Organization:
University of British Columbia
Study Overview
Official Title:
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WITHDRAWN
Status Verified Date:
2014-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsor declined funding
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 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
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