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

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

Study Contact Backup

Study Locations

      • 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:

    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.

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

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

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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