Vitamin C Effectiveness in Preventing Urinary Tract Infections After Gynecological Surgeries

NCT05913180 | Recruiting Phase 2 DMC

• 1 other identifier: 62/137-H/77-2023-25-2295
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

Double-blind placebo-controlled randomized trial aiming to assess the role of Vitamin C supplementation in the prevention of catheter-associated urinary tract infections in women undergoing elective gynecological surgeries.

Conditions

Catheter-Associated Urinary Tract Infection

Keywords

Ascorbic acid; Vitamin C; Elective Gynecologic surgeries; CAUTI

Outcome Measures

Primary Outcomes (1)

• Incidence of UTI

  The Primary endpoint is the proportion of participants who experience a clinically diagnosed and treated UTI as evidenced by a positive urine culture.

  30 days

Secondary Outcomes (1)

• Asymptomatic UTI

  30 days

Study Arms (2)

Vitamin C

ACTIVE COMPARATOR

1000mg Ascorbic acid daily starting the day of elective gynecological surgery for 10 days

Drug: Ascorbic Acid 1000 MG

Placebo

PLACEBO COMPARATOR

Placebo daily starting the day of elective gynecological surgery for 10 days

Drug: Placebo

Interventions

Ascorbic Acid 1000 MG DRUG

1000mg Ascorbic acid orally daily started on the day of elective gynecological surgery for 10 days

Also known as: Vitamin C

Vitamin C

Placebo DRUG

Placebo tablet daily starting day of elective gynecological surgery for 10 days

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Nonpregnant women
• years of age or older
• Undergoing elective GYN surgery

You may not qualify if:

• Pregnant women
• Already taking Vitamin C supplementation
• Nephrolithiasis
• Congenital anomaly or neurogenic bladder
• Allergy to ascorbic acid
• On therapeutic anticoagulant medicine during the 6 weeks after surgery
• Gynecological surgery involving fistula repair or a vaginal mesh removal
• Positive Urinalysis in the pre-admission unit
• Recurrent UTIs
• Diabetes
• G6PD
• Hemochromatosis
• Renal disorders

Sponsors & Collaborators

• American University of Beirut Medical Center: lead
• Moscow State University of Medicine and Dentistry: collaborator

Study Sites (1)

Moscow State University of Medicine and Dentistry

Moscow, Russia

RECRUITING

Related Publications (7)

• 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.

  PMID: 25882919 BACKGROUND

• 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.

  PMID: 17611821 BACKGROUND

• 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.

  PMID: 11730365 BACKGROUND

• 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.

  PMID: 15111369 BACKGROUND

• 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.

  PMID: 21148516 BACKGROUND

• Hickling DR, Nitti VW. Management of recurrent urinary tract infections in healthy adult women. Rev Urol. 2013;15(2):41-8.

  PMID: 24082842 BACKGROUND

• 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.

  PMID: 18559747 BACKGROUND

MeSH Terms

Interventions

Ascorbic Acid

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Study Officials

• Tony Bazi, M.D.

  American University of Beirut Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tony Bazi, M.D.

CONTACT

9611350000; tb04@aub.edu.lb

George kasyan, M.D.

CONTACT

g.kasyan@outlook.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Double blinded
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Clinical Obstetrics and Gynecology

Study Record Dates

• First Submitted: June 10, 2023
• First Posted: June 22, 2023
• Study Start: September 19, 2023
• Primary Completion (Estimated): August 15, 2026
• Study Completion (Estimated): August 15, 2026
• Last Updated: December 30, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)