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

NCT ID: NCT03800667

Last Updated: 2019-07-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

EARLY_PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-08

Study Completion Date

2019-07-12

Brief Summary

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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.

Detailed Description

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Conditions

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Catheter-Associated Urinary Tract Infection, Ascorbic Acid

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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,

Group Type EXPERIMENTAL

Ascorbic Acid 1000 MG

Intervention Type DRUG

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

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Ascorbic Acid 1000 MG

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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American University of Beirut Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Tony Bazi

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tony Bazi, MD

Role: PRINCIPAL_INVESTIGATOR

American University of Beirut Medical Center

Locations

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American University of Beirut Medical Center

Beirut, , Lebanon

Site Status

Countries

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Lebanon

References

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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.

Reference Type RESULT
PMID: 25882919 (View on PubMed)

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.

Reference Type RESULT
PMID: 17611821 (View on PubMed)

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.

Reference Type RESULT
PMID: 11730365 (View on PubMed)

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.

Reference Type RESULT
PMID: 15111369 (View on PubMed)

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.

Reference Type RESULT
PMID: 21148516 (View on PubMed)

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

Reference Type RESULT
PMID: 24082842 (View on PubMed)

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.

Reference Type RESULT
PMID: 18559747 (View on PubMed)

Other Identifiers

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OGY.TB.09

Identifier Type: -

Identifier Source: org_study_id

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