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

NCT04261036 | Withdrawn Early Phase 1 FDA Drug

• 1 other identifier: OGY.TB.09/BIO-2017-0609
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Catheter-Associated Urinary Tract Infection, Ascorbic Acid

Keywords

Vitamin C; CAUTI; Ascorbic Acid

Outcome Measures

Primary Outcomes (1)

• Proportion of participants who experienced clinically diagnosed and treated UTI.

  Urinary tract infection is diagnosed by a positive urine culture.

  14 days

Secondary Outcomes (1)

• Proportion of participants with asymptomatic bacteruria

  14 days

Study Arms (2)

Women on a vitamin C regimen

EXPERIMENTAL

Women who are undergoing elective gynecological surgeries and who are randomized to take 1g of vitamin C for 14 days.

Drug: Ascorbic Acid 1000 mg

Women on a placebo regimen

PLACEBO COMPARATOR

Women who are undergoing elective gynecological surgeries and who are randomized to take placebo for 14 days

Other: Placebo

Interventions

Ascorbic Acid 1000 mg DRUG

1000 mg ascorbic acid (Vitamin C) for 14 days post-op after an elective gynecological surgery.

Women on a vitamin C regimen

Placebo OTHER

Placebo pills for 14 days post-op after an elective gynecological surgery.

Women on a placebo regimen

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• American University of Beirut Medical Center: lead

Study Sites (1)

American University of Beirut Medical Center

Beirut, Lebanon

Location

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 Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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.
• 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: February 6, 2020
• First Posted: February 7, 2020
• Study Start: July 20, 2019
• Primary Completion: July 1, 2021
• Study Completion: October 1, 2021
• Last Updated: May 30, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

LE (1)