Vitamin C for the Prevention of UTI in Women Who Undergo Elective Gynecological Surgeries
Primary Purpose
Catheter-Associated Urinary Tract Infection, Ascorbic Acid
Status
Withdrawn
Phase
Early Phase 1
Locations
Lebanon
Study Type
Interventional
Intervention
Ascorbic Acid 1000 mg
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Catheter-Associated Urinary Tract Infection, Ascorbic Acid focused on measuring Vitamin C, CAUTI, Ascorbic Acid
Eligibility Criteria
Inclusion Criteria:
- Non pregnant women at least 18 years of age visiting the Preadmission unit (PAU) or the OBGYN floor (7N), presenting for elective GYN surgery at the American University of Beirut Medical Center (AUBMC).
Exclusion Criteria:
Any women with the following:
- Nephrolithiasis
- Congenital anomaly or neurogenic bladder
- Allergy to ascorbic acid
- Who require therapeutic anticoagulant medicine during the 6 weeks after surgery
- Surgery did involve a fistula repair or a vaginal mesh removal
- Positive Urinalysis in the PAU
- Recurrent UTI's
- Diabetes
- G6PD
- Hemochromatosis
- Renal disorders
Patients already taking Vitamin C supplementation will also be excluded from the study.
Sites / Locations
- American University of Beirut Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Women on a vitamin C regimen
Women on a placebo regimen
Arm Description
Women who are undergoing elective gynecological surgeries and who are randomized to take 1g of vitamin C for 14 days.
Women who are undergoing elective gynecological surgeries and who are randomized to take placebo for 14 days
Outcomes
Primary Outcome Measures
Proportion of participants who experienced clinically diagnosed and treated UTI.
Urinary tract infection is diagnosed by a positive urine culture.
Secondary Outcome Measures
Proportion of participants with asymptomatic bacteruria
Participants with positive urine culture but no symptoms
Full Information
NCT ID
NCT04261036
First Posted
February 6, 2020
Last Updated
May 26, 2023
Sponsor
American University of Beirut Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT04261036
Brief Title
Vitamin C for the Prevention of UTI in Women Who Undergo Elective Gynecological Surgeries
Official Title
Vitamin C for the Prevention of Catheter-associated Urinary Tract Infections in Women Who Undergo Elective Gynecological Surgeries: a Study Protocol for a Randomized Double Blinded Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Withdrawn
Why Stopped
Unfortunately, the economic crisis in Lebanon precluded utilization of available funding to recruit patients at the specified institution. No patients were recruited.
Study Start Date
July 20, 2019 (Actual)
Primary Completion Date
July 1, 2021 (Anticipated)
Study Completion Date
October 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
American University of Beirut Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
This open-label randomized trial aims at assessing the role of Vitamin C pills in the prevention of catheter-associated urinary tract infections in women undergoing elective gynecological surgeries.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Catheter-Associated Urinary Tract Infection, Ascorbic Acid
Keywords
Vitamin C, CAUTI, Ascorbic Acid
7. Study Design
Primary Purpose
Prevention
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Masking Description
Vitamin C and Placebo pills will be blindly labeled and assorted in opaque containers in the Pharmacy department according to a computer generated list that allocated random assignment of vitamin C or placebo to a 200 positions (serial numbers from 1 to 200).
The research assistant in charge of the recuitment will not be aware of the content of each opaque container and would be providing them to patients according to the order in which they are recruited starting with container number 1, then 2 and so on.
The primary care provider and the investigators are blinded as well as they are not aware of the assignment of each recruited patient to placebo vs interventional arm.
It is only upon completion of data collection that results would be compared with the randomized generated list in order to link the recruited patients and their collected data with their original assignment to placebo vs intervention.
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Women on a vitamin C regimen
Arm Type
Experimental
Arm Description
Women who are undergoing elective gynecological surgeries and who are randomized to take 1g of vitamin C for 14 days.
Arm Title
Women on a placebo regimen
Arm Type
Placebo Comparator
Arm Description
Women who are undergoing elective gynecological surgeries and who are randomized to take placebo for 14 days
Intervention Type
Drug
Intervention Name(s)
Ascorbic Acid 1000 mg
Intervention Description
1000 mg ascorbic acid (Vitamin C) for 14 days post-op after an elective gynecological surgery.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo pills for 14 days post-op after an elective gynecological surgery.
Primary Outcome Measure Information:
Title
Proportion of participants who experienced clinically diagnosed and treated UTI.
Description
Urinary tract infection is diagnosed by a positive urine culture.
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Proportion of participants with asymptomatic bacteruria
Description
Participants with positive urine culture but no symptoms
Time Frame
14 days
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Non pregnant women at least 18 years of age visiting the Preadmission unit (PAU) or the OBGYN floor (7N), presenting for elective GYN surgery at the American University of Beirut Medical Center (AUBMC).
Exclusion Criteria:
Any women with the following:
Nephrolithiasis
Congenital anomaly or neurogenic bladder
Allergy to ascorbic acid
Who require therapeutic anticoagulant medicine during the 6 weeks after surgery
Surgery did involve a fistula repair or a vaginal mesh removal
Positive Urinalysis in the PAU
Recurrent UTI's
Diabetes
G6PD
Hemochromatosis
Renal disorders
Patients already taking Vitamin C supplementation will also be excluded from the study.
Facility Information:
Facility Name
American University of Beirut Medical Center
City
Beirut
Country
Lebanon
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
25882919
Citation
Foxman B, Cronenwett AE, Spino C, Berger MB, Morgan DM. Cranberry juice capsules and urinary tract infection after surgery: results of a randomized trial. Am J Obstet Gynecol. 2015 Aug;213(2):194.e1-8. doi: 10.1016/j.ajog.2015.04.003. Epub 2015 Apr 13.
Results Reference
background
PubMed Identifier
17611821
Citation
Ochoa-Brust GJ, Fernandez AR, Villanueva-Ruiz GJ, Velasco R, Trujillo-Hernandez B, Vasquez C. Daily intake of 100 mg ascorbic acid as urinary tract infection prophylactic agent during pregnancy. Acta Obstet Gynecol Scand. 2007;86(7):783-7. doi: 10.1080/00016340701273189.
Results Reference
background
PubMed Identifier
11730365
Citation
Carlsson S, Wiklund NP, Engstrand L, Weitzberg E, Lundberg JO. Effects of pH, nitrite, and ascorbic acid on nonenzymatic nitric oxide generation and bacterial growth in urine. Nitric Oxide. 2001 Dec;5(6):580-6. doi: 10.1006/niox.2001.0371.
Results Reference
background
PubMed Identifier
15111369
Citation
Trautner BW, Darouiche RO. Catheter-associated infections: pathogenesis affects prevention. Arch Intern Med. 2004 Apr 26;164(8):842-50. doi: 10.1001/archinte.164.8.842.
Results Reference
background
PubMed Identifier
21148516
Citation
Barbosa-Cesnik C, Brown MB, Buxton M, Zhang L, DeBusscher J, Foxman B. Cranberry juice fails to prevent recurrent urinary tract infection: results from a randomized placebo-controlled trial. Clin Infect Dis. 2011 Jan 1;52(1):23-30. doi: 10.1093/cid/ciq073.
Results Reference
background
PubMed Identifier
24082842
Citation
Hickling DR, Nitti VW. Management of recurrent urinary tract infections in healthy adult women. Rev Urol. 2013;15(2):41-8.
Results Reference
background
PubMed Identifier
18559747
Citation
Wald HL, Ma A, Bratzler DW, Kramer AM. Indwelling urinary catheter use in the postoperative period: analysis of the national surgical infection prevention project data. Arch Surg. 2008 Jun;143(6):551-7. doi: 10.1001/archsurg.143.6.551.
Results Reference
background
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Vitamin C for the Prevention of UTI in Women Who Undergo Elective Gynecological Surgeries
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