NCT03800667

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2018

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 8, 2018

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 9, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 11, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 12, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 12, 2019

Completed
Last Updated

July 15, 2019

Status Verified

July 1, 2019

Enrollment Period

11 months

First QC Date

January 9, 2019

Last Update Submit

July 12, 2019

Conditions

Catheter-Associated Urinary Tract Infection, Ascorbic Acid

Keywords

Vitamin C, CAUTI

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.

    30 days

Study Arms (2)

Women on a vitamin C regimen

EXPERIMENTAL

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

Women not taking vitamin C

NO INTERVENTION

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

Interventions

Ascorbic Acid 1000 MGDRUG

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

Women on a vitamin C regimen

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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: 25882919RESULT

  • 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: 17611821RESULT

  • 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: 11730365RESULT

  • 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: 15111369RESULT

  • 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: 21148516RESULT

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

    PMID: 24082842RESULT

  • 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: 18559747RESULT

MeSH Terms

Interventions

Ascorbic Acid

Intervention Hierarchy (Ancestors)

Sugar AcidsAcids, AcyclicCarboxylic AcidsOrganic ChemicalsHydroxy AcidsCarbohydrates

Study Officials

  • Tony Bazi, MD

    American University of Beirut Medical Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

January 9, 2019

First Posted

January 11, 2019

Study Start

August 8, 2018

Primary Completion

July 12, 2019

Study Completion

July 12, 2019

Last Updated

July 15, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

LE(1)