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Vitamin C for the Prevention of UTI in Women Who Undergo Elective GYN 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Withdrawn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
Sponsored by
American University of Beirut Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Catheter-Associated Urinary Tract Infection, Ascorbic Acid focused on measuring Vitamin C, CAUTI

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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:

    1. Nephrolithiasis
    2. Congenital anomaly or neurogenic bladder
    3. Allergy to ascorbic acid
    4. Who require therapeutic anticoagulant medicine during the 6 weeks after surgery
    5. Surgery did involve a fistula repair or a vaginal mesh removal
    6. Positive Urinalysis in the PAU
    7. Recurrent UTI's
    8. Diabetes
    9. G6PD
    10. Hemochromatosis
    11. 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

No Intervention

Arm Label

Women on a vitamin C regimen

Women not taking vitamin C

Arm Description

Women who are undergoing elective gynecological surgeries and who are randomized to take 1000 mg of vitamin C for one month,

Women who are undergoing elective gynecological surgeries and who are randomized not to take any vitamin C for one month.

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

Full Information

First Posted
January 9, 2019
Last Updated
July 12, 2019
Sponsor
American University of Beirut Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03800667
Brief Title
Vitamin C for the Prevention of UTI in Women Who Undergo Elective GYN Surgeries
Official Title
Vitamin C for the Prevention of UTI in Women Who Undergo Elective GYN Surgeries: a Study Protocol for a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Withdrawn
Why Stopped
No funds
Study Start Date
August 8, 2018 (Actual)
Primary Completion Date
July 12, 2019 (Actual)
Study Completion Date
July 12, 2019 (Actual)

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

7. Study Design

Primary Purpose
Prevention
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
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 1000 mg of vitamin C for one month,
Arm Title
Women not taking vitamin C
Arm Type
No Intervention
Arm Description
Women who are undergoing elective gynecological surgeries and who are randomized not to take any vitamin C for one month.
Intervention Type
Drug
Intervention Name(s)
Ascorbic Acid 1000 MG
Intervention Description
1000 mg ascorbic acid (Vitamin C) for 1 month 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
30 days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tony Bazi, MD
Organizational Affiliation
American University of Beirut Medical Center
Official's Role
Principal Investigator
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
result
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
result
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
result
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
result
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
result
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
result
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
result

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Vitamin C for the Prevention of UTI in Women Who Undergo Elective GYN Surgeries

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