- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04261036
Vitamin C for the Prevention of UTI in Women Who Undergo Elective Gynecological Surgeries
May 26, 2023 updated by: Tony Bazi, American University of Beirut Medical Center
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.
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.
Study Overview
Status
Withdrawn
Intervention / Treatment
Study Type
Interventional
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Tony Bazi, MD
- Phone Number: 9611350000
- Email: tb04@aub.edu.lb
Study Contact Backup
- Name: Omar Z Baba, MD
- Phone Number: 9613596474
- Email: ob07@aub.edu.lb
Study Locations
-
-
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Beirut, Lebanon
- American University of Beirut Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Women on a vitamin C regimen
Women who are undergoing elective gynecological surgeries and who are randomized to take 1g of vitamin C for 14 days.
|
1000 mg ascorbic acid (Vitamin C) for 14 days post-op after an elective gynecological surgery.
|
Placebo Comparator: Women on a placebo regimen
Women who are undergoing elective gynecological surgeries and who are randomized to take placebo for 14 days
|
Placebo pills for 14 days post-op after an elective gynecological surgery.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of participants who experienced clinically diagnosed and treated UTI.
Time Frame: 14 days
|
Urinary tract infection is diagnosed by a positive urine culture.
|
14 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of participants with asymptomatic bacteruria
Time Frame: 14 days
|
Participants with positive urine culture but no symptoms
|
14 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- Hickling DR, Nitti VW. Management of recurrent urinary tract infections in healthy adult women. Rev Urol. 2013;15(2):41-8.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 20, 2019
Primary Completion (Estimated)
July 1, 2021
Study Completion (Estimated)
October 1, 2021
Study Registration Dates
First Submitted
February 6, 2020
First Submitted That Met QC Criteria
February 6, 2020
First Posted (Actual)
February 7, 2020
Study Record Updates
Last Update Posted (Actual)
May 30, 2023
Last Update Submitted That Met QC Criteria
May 26, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Urologic Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Male Urogenital Diseases
- Infections
- Urinary Tract Infections
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Protective Agents
- Micronutrients
- Vitamins
- Antioxidants
- Ascorbic Acid
Other Study ID Numbers
- OGY.TB.09/BIO-2017-0609
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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