<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03800667</url>
  </required_header>
  <id_info>
    <org_study_id>OGY.TB.09</org_study_id>
    <nct_id>NCT03800667</nct_id>
  </id_info>
  <brief_title>Vitamin C for the Prevention of UTI in Women Who Undergo Elective GYN Surgeries</brief_title>
  <official_title>Vitamin C for the Prevention of UTI in Women Who Undergo Elective GYN Surgeries: a Study Protocol for a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>American University of Beirut Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>American University of Beirut Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This open-label randomized trial aims at assessing the role of Vitamin C pills in the&#xD;
      prevention of catheter-associated urinary tract infections in women undergoing elective&#xD;
      gynecological surgeries.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    No funds&#xD;
  </why_stopped>
  <start_date type="Actual">August 8, 2018</start_date>
  <completion_date type="Actual">July 12, 2019</completion_date>
  <primary_completion_date type="Actual">July 12, 2019</primary_completion_date>
  <phase>Early Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of participants who experienced clinically diagnosed and treated UTI.</measure>
    <time_frame>30 days</time_frame>
    <description>Urinary tract infection is diagnosed by a positive urine culture.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Catheter-Associated Urinary Tract Infection, Ascorbic Acid</condition>
  <arm_group>
    <arm_group_label>Women on a vitamin C regimen</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Women who are undergoing elective gynecological surgeries and who are randomized to take 1000 mg of vitamin C for one month,</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Women not taking vitamin C</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Women who are undergoing elective gynecological surgeries and who are randomized not to take any vitamin C for one month.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ascorbic Acid 1000 MG</intervention_name>
    <description>1000 mg ascorbic acid (Vitamin C) for 1 month post-op after an elective gynecological surgery.</description>
    <arm_group_label>Women on a vitamin C regimen</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Non pregnant women at least 18 years of age visiting the Preadmission unit (PAU) or the&#xD;
        OBGYN floor (7N), presenting for elective GYN surgery at the American University of Beirut&#xD;
        Medical Center (AUBMC).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any women with the following:&#xD;
&#xD;
               1. Nephrolithiasis&#xD;
&#xD;
               2. Congenital anomaly or neurogenic bladder&#xD;
&#xD;
               3. Allergy to ascorbic acid&#xD;
&#xD;
               4. Who require therapeutic anticoagulant medicine during the 6 weeks after surgery&#xD;
&#xD;
               5. Surgery did involve a fistula repair or a vaginal mesh removal&#xD;
&#xD;
               6. Positive Urinalysis in the PAU&#xD;
&#xD;
               7. Recurrent UTI's&#xD;
&#xD;
               8. Diabetes&#xD;
&#xD;
               9. G6PD&#xD;
&#xD;
              10. Hemochromatosis&#xD;
&#xD;
              11. Renal disorders&#xD;
&#xD;
        Patients already taking Vitamin C supplementation will also be excluded from the study.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tony Bazi, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>American University of Beirut Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>American University of Beirut Medical Center</name>
      <address>
        <city>Beirut</city>
        <country>Lebanon</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Lebanon</country>
  </location_countries>
  <results_reference>
    <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.</citation>
    <PMID>25882919</PMID>
  </results_reference>
  <results_reference>
    <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.</citation>
    <PMID>17611821</PMID>
  </results_reference>
  <results_reference>
    <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.</citation>
    <PMID>11730365</PMID>
  </results_reference>
  <results_reference>
    <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.</citation>
    <PMID>15111369</PMID>
  </results_reference>
  <results_reference>
    <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.</citation>
    <PMID>21148516</PMID>
  </results_reference>
  <results_reference>
    <citation>Hickling DR, Nitti VW. Management of recurrent urinary tract infections in healthy adult women. Rev Urol. 2013;15(2):41-8.</citation>
    <PMID>24082842</PMID>
  </results_reference>
  <results_reference>
    <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.</citation>
    <PMID>18559747</PMID>
  </results_reference>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>January 9, 2019</study_first_submitted>
  <study_first_submitted_qc>January 9, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 11, 2019</study_first_posted>
  <last_update_submitted>July 12, 2019</last_update_submitted>
  <last_update_submitted_qc>July 12, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>American University of Beirut Medical Center</investigator_affiliation>
    <investigator_full_name>Tony Bazi</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>Vitamin C, CAUTI</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urinary Tract Infections</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ascorbic Acid</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03800667
org study id: OGY.TB.09
nct id: NCT03800667
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Proportion of participants who experienced clinically diagnosed and treated UTI.
time frame: 30 days
description: Urinary tract infection is diagnosed by a positive urine culture.
arm group label: Women on a vitamin C regimen
arm group type: Experimental
description: Women who are undergoing elective gynecological surgeries and who are randomized to take 1000 mg of vitamin C for one month,
arm group label: Women not taking vitamin C
arm group type: No Intervention
description: Women who are undergoing elective gynecological surgeries and who are randomized not to take any vitamin C for one month.
intervention type: Drug
intervention name: Ascorbic Acid 1000 MG
description: 1000 mg ascorbic acid (Vitamin C) for 1 month post-op after an elective gynecological surgery.
arm group label: Women on a vitamin C regimen
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Tony Bazi, MD
role: Principal Investigator
affiliation: American University of Beirut Medical Center
facility: 
country: Lebanon
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: 25882919
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: 17611821
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: 11730365
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: 15111369
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: 21148516
citation: Hickling DR, Nitti VW. Management of recurrent urinary tract infections in healthy adult women. Rev Urol. 2013;15(2):41-8.
PMID: 24082842
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.
PMID: 18559747
responsible party type: Principal Investigator
investigator affiliation: American University of Beirut Medical Center
investigator full name: Tony Bazi
investigator title: MD
mesh term: Urinary Tract Infections
mesh term: Ascorbic Acid
sharing ipd: No