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Trial record 66 of 159 for:    Urinary Tract Infections | Recruiting, Not yet recruiting, Available Studies | "Communicable Diseases"

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

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ClinicalTrials.gov Identifier: NCT03800667
Recruitment Status : Recruiting
First Posted : January 11, 2019
Last Update Posted : January 11, 2019
Sponsor:
Information provided by (Responsible Party):
Tony Bazi, American University of Beirut Medical Center

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.

Condition or disease Intervention/treatment Phase
Catheter-Associated Urinary Tract Infection, Ascorbic Acid Drug: Ascorbic Acid 1000 MG Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Vitamin C for the Prevention of UTI in Women Who Undergo Elective GYN Surgeries: a Study Protocol for a Randomized Controlled Trial
Actual Study Start Date : August 8, 2018
Estimated Primary Completion Date : January 30, 2019
Estimated Study Completion Date : April 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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,
Drug: Ascorbic Acid 1000 MG
1000 mg ascorbic acid (Vitamin C) for 1 month post-op after an elective gynecological surgery.

No Intervention: 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.



Primary Outcome Measures :
  1. Proportion of participants who experienced clinically diagnosed and treated UTI. [ Time Frame: 30 days ]
    Urinary tract infection is diagnosed by a positive urine culture.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03800667


Contacts
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Contact: Tony Bazi, MD 9611350000 tb04@aub.edu.lb

Locations
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Lebanon
American University of Beirut Medical Center Recruiting
Beirut, Lebanon
Contact: Tony Bazi, MD         
Sponsors and Collaborators
American University of Beirut Medical Center
Investigators
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Principal Investigator: Tony Bazi, MD American University of Beirut Medical Center

Publications of Results:
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Responsible Party: Tony Bazi, MD, American University of Beirut Medical Center
ClinicalTrials.gov Identifier: NCT03800667     History of Changes
Other Study ID Numbers: OGY.TB.09
First Posted: January 11, 2019    Key Record Dates
Last Update Posted: January 11, 2019
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Tony Bazi, American University of Beirut Medical Center:
Vitamin C, CAUTI

Additional relevant MeSH terms:
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Urinary Tract Infections
Infection
Urologic Diseases
Vitamins
Ascorbic Acid
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents