Recurrent Urinary Tract InfectionPhase 2NCT04859621
Phase II Clinical Trial of Vitamin D3 for Reducing Recurrence of Recurrent Lower Urinary Tract Infections
A Phase 2 study testing Vitamin D3 4000 IU, Vitamin D3 2000 IU and standard antibiotic therapy in people with Recurrent Urinary Tract Infection, run by Zensun Sci. & Tech. Co., Ltd. at 6 sites in China.
Trial summary
The aim of this study was to initially evaluate the optimal dose, efficacy, and safety of vitamin D3 for reducing recurrence of recurrent urinary tract infections (rUTIs). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Recurrent Urinary Tract Infection
- What is being tested?
- Vitamin D3 4000 IU, Vitamin D3 2000 IU and standard antibiotic therapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 6 sitesChina
- Study dates
- 8 May 2021to 30 Jul 2025
- Phase
- Phase 2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female aged 18 to 75 years, including 18 and 75 years;
- at least 3 episodes of lower urinary tract infection in the last 12 months or at least 2 episodes of lower urinary tract infection in the last 6 months;
- The symptoms of the latest recurrence of lower urinary tract infection have disappeared after treatment, and the treatment dosage of antibiotics has been stopped, and at least one of the following two conditions has been met:A) The middle urinary bacterial culture is less than 10^5 CFU/mL (accept the examination results after the last improvement);B) Urine white blood cell count is less than 5 /HP, and if it can be measured in routine urine examination, it should be less than 25 /μL;
- Signed written informed consent;
- Be able to follow the research protocol.
Who cannot join
- Complicated with cardio-cerebrovascular and hematopoietic system and other serious primary diseases;
- Poor glycemic control (HbA1c >7.5%) with diabetes;
- Patients with genital tract malformation or acute genital tract infection and genital tract tumor;
- Patients with urinary system tuberculosis and acute pyelonephritis;
- Patients with cysto-ureteral reflux or urethral reflux;
- Patients with polycystic kidney disease, neurogenic bladder, indwelling urethral catheterization, urinary tract stones, tumors or fibrous degeneration, etc., determined by the investigator as urinary tract obstruction;
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- Glomerular filtration rate (MDRD formula).20 mL/min/1.73m2, dialysis or kidney transplantation patients;
- Chronic liver disease may have potential influence on liver function (bilirubin >;1.5 times upper limit of normal value, aspartate aminotransferase or alanine aminotransferase >2 times the upper limit of normal);
- Patients with vitamin D3 contraindications, such as hypercalcemia, hypervitaminism, hyperphosphatemia with renal rickets, etc.;
- Patients with diseases that affect the absorption of vitamin D3 in the small intestine, such as Crohn's disease;
- receiving immunosuppressive agents or GT;10 mg/d glucocorticoids;
- had received any other investigational drug therapy or participated in another interventional clinical trial within 30 days prior to screening;
- Have a history of alcohol or drug abuse or suffer from mental illness;
- Women of child-bearing age who have planned to become pregnant within 2 years (women of child-bearing age are defined as all women with physical ability to become pregnant), or women who are pregnant or lactating;
- Circumstances in which subjects are judged by the investigator to be unsuitable for inclusion.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
China6 sites, 6 recruiting
- Recruiting
Sichuan Provincial People's Hospital
Chengdu, Sichuan
Li Wang, 13708016939, scwangli62@163.com
- Recruiting
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, 200025
Xian He, MD, 57185239988, Hx.hzsy@163.com
- Recruiting
Shanghai Oriental Hospital
Shanghai, Shanghai Municipality
Na Liu, 18217768587, naliubrown@163.com
- Recruiting
The Fifth People's Hospital, Shanghai
Shanghai, Shanghai Municipality
Jianying Niu, 18918168518, njyphd2008@163.com
- Recruiting
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine，Chongming Branch
Shanghai, Shanghai Municipality
Chun Zhu, 13611951773, zhuchun26@sina.cn
- Recruiting
The First Affiliated Hospital of Xi 'an Jiaotong University
Xi'an, Shaanxi
Aiping Yin, 18991232130, aipingy@126.com
About this study
Official title: Phase II Clinical Trial of Vitamin D3 for Reducing Recurrence of Recurrent Lower Urinary Tract Infections: a Multicenter, Randomized, Placebo-controlled Trial
The aim of this study was to initially evaluate the optimal dose, efficacy, and safety of vitamin D3 for reducing recurrence of recurrent urinary tract infections (rUTIs).
Read the detailed description
Urinary tract infection (UTI) is a multiple disease that ranks second only to respiratory infections in infectious diseases and is one of the most common infectious diseases among adults. After the first urinary tract infection, the probability of recurrence within half a year and within one year was as high as 24% and 70%, respectively. Urinary tract infection itself has the characteristics of easy recurrence, which is closely related to the abuse of antibiotics, the generation of bacterial resistance, and the decline of local immune function of mucosa.
In the urinary tract, the antibacterial peptide Cathelicidin is mainly located in the proximal tubules of the kidney and the epithelial cells of the renal pelvis and ureter. LL37 is the only antibacterial peptide present in the human body of the Cathelicidin family, which can be regarded as a natural antibiotic produced by the body. Antibacterial peptides have a broad-spectrum antibacterial effect and can exert antibacterial effects against both Gram-positive and Gram-negative bacteria. Vitamin D intake increases the activity of endogenous antimicrobial peptides. Preclinical cell test of Zensun Sci. \& Tech. Co., Ltd. confirmed the induction of LL37 in urethral epithelial cells by vitamin D and its broad-spectrum antibacterial effect. Animal experiments also showed the therapeutic effect of LL37 on UTI.
- Conditions
- Recurrent Urinary Tract Infection
- Being tested
- Vitamin D3 4000 IU, Vitamin D3 2000 IU, Placebo, standard antibiotic therapy
- Keywords
- Vitamin D3, Recurrent lower urinary tract infection
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D3 4000 IUDrug
Oral administration, 2 tablet per time, qd, oral administration with the first meal, continuous use for 48 weeks
Vitamin D3 2000 IUDrug
Oral administration, 1 tablet of each per time, qd, oral administration with the first meal, continuous use for 48 weeks
PlaceboDrug
Oral administration, 2 tablet per time, qd, oral administration with the first meal, continuous use for 48 weeks
standard antibiotic therapyOther
standard antibiotic therapy
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D3 4000 IU | Experimental | 4000IU Vitamin D3 Oral Tablet plus standard antibiotic therapy Receives: Drug: Vitamin D3 4000 IU; Other: standard antibiotic therapy |
| Vitamin D3 2000 IU | Experimental | 2000IU Vitamin D3 Oral Tablet plus standard antibiotic therapy Receives: Drug: Vitamin D3 2000 IU; Other: standard antibiotic therapy |
| Placebo | Placebo comparator | Placebo Oral Tablet plus standard antibiotic therapy Receives: Drug: Placebo; Other: standard antibiotic therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
UTI recurrent incidence in 48 weeks
UTI episodes during 48-week treatment for each subject
Measured: 48 weeks
Secondary outcomes (3)
Recurrence rate of UTI in 48 weeks
Comparing the recurrence rate of UTI between different treatment groups
Measured: 48 weeks
UTI-free duration in 48 weeks
Comparing the number of days from the beginning of the study to the first recurrence of UTI, and the number of days from each recurrence to the next recurrence between different treatment groups.
Measured: 48 weeks
Cumulative relapse-free ratio
Ratio of the cumulative duration of UTI-free period to treatment duration
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2021
- Study start8 May 2021
- Primary completion30 Apr 2025 (estimated)
- Study completion30 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Urinary Tract InfectionStudies 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
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A multicenter, randomized, double-blind, placebo-controlled trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zensun Sci. & Tech. Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xian He, MD, Principal investigator, Zhejiang Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04859621
- Sponsor's protocol ID
- ZS-05
- Status last verified
- Jan 2024
- First submitted
- 21 Apr 2021
- Last updated
- 2 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Clinical Trial of Vitamin D3 for Reducing Recurrence of Recurrent Lower Urinary Tract Infections: a Multicenter, Randomized, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT04859621
- Acronym / sponsor ID
- ZS-05
- Conditions
- Recurrent Urinary Tract Infection
- Keywords
- Vitamin D3, Recurrent lower urinary tract infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Zensun Sci. & Tech. Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 8 May 2021 (actual)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 30 Jul 2025 (estimated)
- First posted
- 26 Apr 2021 (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.
The aim of this study was to initially evaluate the optimal dose, efficacy, and safety of vitamin D3 for reducing recurrence of recurrent urinary tract infections (rUTIs).
Detailed description
Urinary tract infection (UTI) is a multiple disease that ranks second only to respiratory infections in infectious diseases and is one of the most common infectious diseases among adults. After the first urinary tract infection, the probability of recurrence within half a year and within one year was as high as 24% and 70%, respectively. Urinary tract infection itself has the characteristics of easy recurrence, which is closely related to the abuse of antibiotics, the generation of bacterial resistance, and the decline of local immune function of mucosa.
In the urinary tract, the antibacterial peptide Cathelicidin is mainly located in the proximal tubules of the kidney and the epithelial cells of the renal pelvis and ureter. LL37 is the only antibacterial peptide present in the human body of the Cathelicidin family, which can be regarded as a natural antibiotic produced by the body. Antibacterial peptides have a broad-spectrum antibacterial effect and can exert antibacterial effects against both Gram-positive and Gram-negative bacteria. Vitamin D intake increases the activity of endogenous antimicrobial peptides. Preclinical cell test of Zensun Sci. \& Tech. Co., Ltd. confirmed the induction of LL37 in urethral epithelial cells by vitamin D and its broad-spectrum antibacterial effect. Animal experiments also showed the therapeutic effect of LL37 on UTI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- A multicenter, randomized, double-blind, placebo-controlled trial
| Arm | Type | Receives |
|---|---|---|
| Vitamin D3 4000 IU | Experimental | Drug: Vitamin D3 4000 IU, Other: standard antibiotic therapy4000IU Vitamin D3 Oral Tablet plus standard antibiotic therapy |
| Vitamin D3 2000 IU | Experimental | Drug: Vitamin D3 2000 IU, Other: standard antibiotic therapy2000IU Vitamin D3 Oral Tablet plus standard antibiotic therapy |
| Placebo | Placebo comparator | Drug: Placebo, Other: standard antibiotic therapyPlacebo Oral Tablet plus standard antibiotic therapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female aged 18 to 75 years, including 18 and 75 years;
- at least 3 episodes of lower urinary tract infection in the last 12 months or at least 2 episodes of lower urinary tract infection in the last 6 months;
- The symptoms of the latest recurrence of lower urinary tract infection have disappeared after treatment, and the treatment dosage of antibiotics has been stopped, and at least one of the following two conditions has been met:A) The middle urinary bacterial culture is less than 10^5 CFU/mL (accept the examination results after the last improvement);B) Urine white blood cell count is less than 5 /HP, and if it can be measured in routine urine examination, it should be less than 25 /μL;
- Signed written informed consent;
- Be able to follow the research protocol.
Key exclusion criteria (15 listed)
- Complicated with cardio-cerebrovascular and hematopoietic system and other serious primary diseases;
- Poor glycemic control (HbA1c >7.5%) with diabetes;
- Patients with genital tract malformation or acute genital tract infection and genital tract tumor;
- Patients with urinary system tuberculosis and acute pyelonephritis;
- Patients with cysto-ureteral reflux or urethral reflux;
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 |
|---|---|---|
| Vitamin D3 4000 IUOral administration, 2 tablet per time, qd, oral administration with the first meal, continuous use for 48 weeks | Drug | Vitamin D3 4000 IU |
| Vitamin D3 2000 IUOral administration, 1 tablet of each per time, qd, oral administration with the first meal, continuous use for 48 weeks | Drug | Vitamin D3 2000 IU |
| PlaceboOral administration, 2 tablet per time, qd, oral administration with the first meal, continuous use for 48 weeks | Drug | Placebo |
| standard antibiotic therapystandard antibiotic therapy | Other | Placebo, Vitamin D3 2000 IU, Vitamin D3 4000 IU |
Primary outcome
UTI recurrent incidence in 48 weeks
Time frame: 48 weeks
UTI episodes during 48-week treatment for each subject
3 secondary outcomes
Recurrence rate of UTI in 48 weeks
Time frame: 48 weeks
UTI-free duration in 48 weeks
Time frame: 48 weeks
Cumulative relapse-free ratio
Time frame: 48 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2024.
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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.
Xian He, MD principal investigator
Zhejiang Provincial People's Hospital
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vitamin D3 4000 IU, Vitamin D3 2000 IU and standard antibiotic therapy in people with Recurrent Urinary Tract Infection, run by Zensun Sci. & Tech. Co., Ltd. at 6 sites in China.
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 5 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 2 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in China. 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?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Debing Jiang (86-21-50802627, dbjiang@zensun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
UTI recurrent incidence in 48 weeks (time frame: 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Feb 2024.