Catheter-Associated Urinary Tract Infection, Ascorbic AcidEarly Phase 1NCT04261036
Vitamin C for the Prevention of UTI in Women Who Undergo Elective Gynecological Surgeries
A Early Phase 1 study testing Ascorbic Acid 1000 mg in people with Catheter-Associated Urinary Tract Infection, Ascorbic Acid, run by American University of Beirut Medical Center at 1 site in Lebanon.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years, women only
- Conditions the study is for
- Catheter-Associated Urinary Tract Infection, Ascorbic Acid
- What is being tested?
- Ascorbic Acid 1000 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteLebanon
- Study dates
- 20 Jul 2019to 1 Oct 2021
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- Any women with the following:
- Nephrolithiasis
- Congenital anomaly or neurogenic bladder
- Allergy to ascorbic acid
- Who require therapeutic anticoagulant medicine during the 6 weeks after surgery
- Surgery did involve a fistula repair or a vaginal mesh removal
Show all 13Show fewer
- Positive Urinalysis in the PAU
- Recurrent UTI's
- Diabetes
- G6PD
- Hemochromatosis
- Renal disorders
- Patients already taking Vitamin C supplementation will also be excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Vitamin C for the Prevention of Catheter-associated Urinary Tract Infections in Women Who Undergo Elective Gynecological Surgeries: a Study Protocol for a Randomized Double Blinded Controlled Trial.
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.
- Being tested
- Ascorbic Acid 1000 mg, Placebo
- Keywords
- Vitamin C, CAUTI, Ascorbic Acid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ascorbic Acid 1000 mgDrug
1000 mg ascorbic acid (Vitamin C) for 14 days post-op after an elective gynecological surgery.
PlaceboOther
Placebo pills for 14 days post-op after an elective gynecological surgery.
| Study group | Role | What they receive |
|---|---|---|
| Women on a vitamin C regimen | Experimental | Women who are undergoing elective gynecological surgeries and who are randomized to take 1g of vitamin C for 14 days. Receives: Drug: Ascorbic Acid 1000 mg |
| Women on a placebo regimen | Placebo comparator | Women who are undergoing elective gynecological surgeries and who are randomized to take placebo for 14 days Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants who experienced clinically diagnosed and treated UTI.
Urinary tract infection is diagnosed by a positive urine culture.
Measured: 14 days
Secondary outcomes (1)
Proportion of participants with asymptomatic bacteruria
Participants with positive urine culture but no symptoms
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2020
- Study start20 Jul 2019
- Primary completion1 Jul 2021 (estimated)
- Study completion1 Oct 2021 (estimated)
Why it stopped: Unfortunately, the economic crisis in Lebanon precluded utilization of available funding to recruit patients at the specified institution. No patients were recruited.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Catheter-Associated Urinary Tract Infection, Ascorbic AcidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- American University of Beirut Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tony Bazi, American University of Beirut Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04261036
- Sponsor's protocol ID
- OGY.TB.09/BIO-2017-0609
- Status last verified
- May 2023
- First submitted
- 6 Feb 2020
- Last updated
- 30 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25882919Ochoa-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.
PubMed 17611821Carlsson 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.
PubMed 11730365Trautner 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.
PubMed 15111369Barbosa-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.
PubMed 21148516Hickling DR, Nitti VW. Management of recurrent urinary tract infections in healthy adult women. Rev Urol. 2013;15(2):41-8.
PubMed 24082842Wald 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.
PubMed 18559747
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin C for the Prevention of Catheter-associated Urinary Tract Infections in Women Who Undergo Elective Gynecological Surgeries: a Study Protocol for a Randomized Double Blinded Controlled Trial.
- ClinicalTrials.gov ID
- NCT04261036
- Acronym / sponsor ID
- OGY.TB.09/BIO-2017-0609
- Keywords
- Vitamin C, CAUTI, Ascorbic Acid
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unfortunately, the economic crisis in Lebanon precluded utilization of available funding to recruit patients at the specified institution. No patients were recruited.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- American University of Beirut Medical CenterUniversity, hospital or other
- Study start
- 20 Jul 2019 (actual)
- Primary completion
- 1 Jul 2021 (estimated)
- Study completion
- 1 Oct 2021 (estimated)
- First posted
- 7 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Women on a vitamin C regimen | Experimental | Drug: Ascorbic Acid 1000 mgWomen who are undergoing elective gynecological surgeries and who are randomized to take 1g of vitamin C for 14 days. |
| Women on a placebo regimen | Placebo comparator | Other: PlaceboWomen who are undergoing elective gynecological surgeries and who are randomized to take placebo for 14 days |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (13 listed)
- Any women with the following:
- Patients already taking Vitamin C supplementation will also be excluded from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ascorbic Acid 1000 mg1000 mg ascorbic acid (Vitamin C) for 14 days post-op after an elective gynecological surgery. | Drug | Women on a vitamin C regimen |
| PlaceboPlacebo pills for 14 days post-op after an elective gynecological surgery. | Other | Women on a placebo regimen |
Primary outcome
Proportion of participants who experienced clinically diagnosed and treated UTI.
Time frame: 14 days
Urinary tract infection is diagnosed by a positive urine culture.
1 secondary outcome
Proportion of participants with asymptomatic bacteruria
Time frame: 14 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2023.
- Background: PubMed 25882919Foxman 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.
- Background: PubMed 17611821Ochoa-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.
- Background: PubMed 11730365Carlsson 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.
- Background: PubMed 15111369Trautner 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.
- Background: PubMed 21148516Barbosa-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.
- Background: PubMed 24082842Hickling DR, Nitti VW. Management of recurrent urinary tract infections in healthy adult women. Rev Urol. 2013;15(2):41-8.
- Background: PubMed 18559747Wald 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Ascorbic Acid 1000 mg in people with Catheter-Associated Urinary Tract Infection, Ascorbic Acid, run by American University of Beirut Medical Center at 1 site in Lebanon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 30 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lebanon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants who experienced clinically diagnosed and treated UTI. (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04261036, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2023.