Vitamin C for the Prevention of UTI in Women Who Undergo Elective Gynecological Surgeries
NCT ID: NCT04261036
Last Updated: 2023-05-30
Study Results
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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WITHDRAWN
EARLY_PHASE1
INTERVENTIONAL
2019-07-20
2021-10-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
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.
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 1g of vitamin C for 14 days.
Ascorbic Acid 1000 mg
1000 mg ascorbic acid (Vitamin C) for 14 days post-op after an elective gynecological surgery.
Women on a placebo regimen
Women who are undergoing elective gynecological surgeries and who are randomized to take placebo for 14 days
Placebo
Placebo pills for 14 days post-op after an elective gynecological surgery.
Interventions
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Ascorbic Acid 1000 mg
1000 mg ascorbic acid (Vitamin C) for 14 days post-op after an elective gynecological surgery.
Placebo
Placebo pills for 14 days post-op after an elective gynecological surgery.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
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.
18 Years
90 Years
FEMALE
No
Sponsors
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American University of Beirut Medical Center
OTHER
Responsible Party
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Tony Bazi
Associate Professor of Clinical Obstetrics and Gynecology
Locations
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American University of Beirut Medical Center
Beirut, , Lebanon
Countries
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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.
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.
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.
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.
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.
Hickling DR, Nitti VW. Management of recurrent urinary tract infections in healthy adult women. Rev Urol. 2013;15(2):41-8.
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.
Other Identifiers
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OGY.TB.09/BIO-2017-0609
Identifier Type: -
Identifier Source: org_study_id
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