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WithdrawnNCT03800667Updated Jul 15, 2019

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

An Early Phase 1 interventional study of Ascorbic Acid 1000 MG in Catheter-Associated Urinary Tract Infection, Ascorbic Acid, sponsored by American University of Beirut Medical Center. Withdrawn at 1 site in Lebanon. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-07-15.

Sponsored by American University of Beirut Medical Center · Early Phase 1, Interventional, and Prevention

Why this study was withdrawn
No funds

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Aug 2018, registered Jan 2019).
Phase
Early Phase 1
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years and older
Sex
Female
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Study 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.

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Conditions studied

  • Catheter-Associated Urinary Tract Infection, Ascorbic Acid

Keywords

  • Vitamin C, CAUTI
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In context

Urinary Tract Infections

753 studies on the registry are indexed under Urinary Tract Infections; 128 are open to participants now.

Browse Urinary Tract Infections studies →

Lead sponsor

American University of Beirut Medical Center is the lead sponsor of 152 studies on the registry; 27 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

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

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.

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Study design

Phase
Early Phase 1
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Women on a vitamin C regimen

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

    Drug: Ascorbic Acid 1000 MG

  • No intervention
    Women not taking vitamin C

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

Interventions

  • DrugAscorbic Acid 1000 MG

    1000 mg ascorbic acid (Vitamin C) for 1 month post-op after an elective gynecological surgery.

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What researchers measure

Primary outcomes

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

    Urinary tract infection is diagnosed by a positive urine culture.

    Time frame: 30 days

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Study locations

1 site
  • American University of Beirut Medical Center
    Beirut, Lebanon
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References and documents

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. PubMed 25882919 ↗
  • 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. PubMed 17611821 ↗
  • 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. PubMed 11730365 ↗
  • 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. PubMed 15111369 ↗
  • 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. PubMed 21148516 ↗
  • Hickling DR, Nitti VW. Management of recurrent urinary tract infections in healthy adult women. Rev Urol. 2013;15(2):41-8. PubMed 24082842 ↗
  • 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. PubMed 18559747 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 15, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03800667
Lead sponsor
American University of Beirut Medical Center
Responsible party
Tony Bazi (MD, American University of Beirut Medical Center) — Principal investigator
First posted
Jan 11, 2019
Start date
Aug 8, 2018
Primary completion
Jul 12, 2019
Completion
Jul 12, 2019
Last update
Jul 15, 2019

Study contacts

Tony Bazi, MD
principal investigator · American University of Beirut Medical Center

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.

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