Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2026-01-09 @ 6:13 AM
Study NCT ID:
NCT03800667
Status:
WITHDRAWN
Last Update Posted:
2019-07-15
First Post:
2019-01-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vitamin C for the Prevention of UTI in Women Who Undergo Elective GYN Surgeries
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D001205', 'term': 'Ascorbic Acid'}], 'ancestors': [{'id': 'D013400', 'term': 'Sugar Acids'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006880', 'term': 'Hydroxy Acids'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'No funds', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2018-08-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2019-07-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-12', 'studyFirstSubmitDate': '2019-01-09', 'studyFirstSubmitQcDate': '2019-01-09', 'lastUpdatePostDateStruct': {'date': '2019-07-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of participants who experienced clinically diagnosed and treated UTI.', 'timeFrame': '30 days', 'description': 'Urinary tract infection is diagnosed by a positive urine culture.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Vitamin C, CAUTI'], 'conditions': ['Catheter-Associated Urinary Tract Infection, Ascorbic Acid']}, 'referencesModule': {'references': [{'pmid': '25882919', 'type': 'RESULT', 'citation': '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': '17611821', 'type': 'RESULT', 'citation': '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': '11730365', 'type': 'RESULT', 'citation': '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': '15111369', 'type': 'RESULT', 'citation': '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': '21148516', 'type': 'RESULT', 'citation': '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': '24082842', 'type': 'RESULT', 'citation': 'Hickling DR, Nitti VW. Management of recurrent urinary tract infections in healthy adult women. Rev Urol. 2013;15(2):41-8.'}, {'pmid': '18559747', 'type': 'RESULT', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nNon 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).\n\nExclusion Criteria:\n\n* Any women with the following:\n\n 1. Nephrolithiasis\n 2. Congenital anomaly or neurogenic bladder\n 3. Allergy to ascorbic acid\n 4. Who require therapeutic anticoagulant medicine during the 6 weeks after surgery\n 5. Surgery did involve a fistula repair or a vaginal mesh removal\n 6. Positive Urinalysis in the PAU\n 7. Recurrent UTI's\n 8. Diabetes\n 9. G6PD\n 10. Hemochromatosis\n 11. Renal disorders\n\nPatients already taking Vitamin C supplementation will also be excluded from the study."}, 'identificationModule': {'nctId': 'NCT03800667', 'briefTitle': 'Vitamin C for the Prevention of UTI in Women Who Undergo Elective GYN Surgeries', 'organization': {'class': 'OTHER', 'fullName': 'American University of Beirut Medical Center'}, 'officialTitle': 'Vitamin C for the Prevention of UTI in Women Who Undergo Elective GYN Surgeries: a Study Protocol for a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'OGY.TB.09'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Women on a vitamin C regimen', 'description': 'Women who are undergoing elective gynecological surgeries and who are randomized to take 1000 mg of vitamin C for one month,', 'interventionNames': ['Drug: Ascorbic Acid 1000 MG']}, {'type': 'NO_INTERVENTION', 'label': 'Women not taking vitamin C', 'description': 'Women who are undergoing elective gynecological surgeries and who are randomized not to take any vitamin C for one month.'}], 'interventions': [{'name': 'Ascorbic Acid 1000 MG', 'type': 'DRUG', 'description': '1000 mg ascorbic acid (Vitamin C) for 1 month post-op after an elective gynecological surgery.', 'armGroupLabels': ['Women on a vitamin C regimen']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beirut', 'country': 'Lebanon', 'facility': 'American University of Beirut Medical Center', 'geoPoint': {'lat': 33.89332, 'lon': 35.50157}}], 'overallOfficials': [{'name': 'Tony Bazi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'American University of Beirut Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'American University of Beirut Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Tony Bazi', 'investigatorAffiliation': 'American University of Beirut Medical Center'}}}}