Phase II Clinical Trial of Vitamin D3 for Reducing Recurrence of Recurrent Lower Urinary Tract Infections
NCT ID: NCT04859621
Last Updated: 2024-02-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
150 participants
INTERVENTIONAL
2021-05-08
2025-07-30
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Vitamin D3 4000 IU
4000IU Vitamin D3 Oral Tablet plus standard antibiotic therapy
Vitamin D3 4000 IU
Oral administration, 2 tablet per time, qd, oral administration with the first meal, continuous use for 48 weeks
standard antibiotic therapy
standard antibiotic therapy
Vitamin D3 2000 IU
2000IU Vitamin D3 Oral Tablet plus standard antibiotic therapy
Vitamin D3 2000 IU
Oral administration, 1 tablet of each per time, qd, oral administration with the first meal, continuous use for 48 weeks
standard antibiotic therapy
standard antibiotic therapy
Placebo
Placebo Oral Tablet plus standard antibiotic therapy
Placebo
Oral administration, 2 tablet per time, qd, oral administration with the first meal, continuous use for 48 weeks
standard antibiotic therapy
standard antibiotic therapy
Interventions
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Vitamin D3 4000 IU
Oral administration, 2 tablet per time, qd, oral administration with the first meal, continuous use for 48 weeks
Vitamin D3 2000 IU
Oral administration, 1 tablet of each per time, qd, oral administration with the first meal, continuous use for 48 weeks
Placebo
Oral administration, 2 tablet per time, qd, oral administration with the first meal, continuous use for 48 weeks
standard antibiotic therapy
standard antibiotic therapy
Eligibility Criteria
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Inclusion Criteria
2. 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;
3. 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;
4. Signed written informed consent;
5. Be able to follow the research protocol.
Exclusion Criteria
2. Poor glycemic control (HbA1c \>7.5%) with diabetes;
3. Patients with genital tract malformation or acute genital tract infection and genital tract tumor;
4. Patients with urinary system tuberculosis and acute pyelonephritis;
5. Patients with cysto-ureteral reflux or urethral reflux;
6. 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;
7. Glomerular filtration rate (MDRD formula).20 mL/min/1.73m2, dialysis or kidney transplantation patients;
8. 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);
9. Patients with vitamin D3 contraindications, such as hypercalcemia, hypervitaminism, hyperphosphatemia with renal rickets, etc.;
10. Patients with diseases that affect the absorption of vitamin D3 in the small intestine, such as Crohn's disease;
11. receiving immunosuppressive agents or GT;10 mg/d glucocorticoids;
12. had received any other investigational drug therapy or participated in another interventional clinical trial within 30 days prior to screening;
13. Have a history of alcohol or drug abuse or suffer from mental illness;
14. 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;
15. Circumstances in which subjects are judged by the investigator to be unsuitable for inclusion.
18 Years
75 Years
ALL
No
Sponsors
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Zensun Sci. & Tech. Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Xian He, MD
Role: PRINCIPAL_INVESTIGATOR
Zhejiang Provincial People's Hospital
Locations
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The First Affiliated Hospital of Xi 'an Jiaotong University
Xi'an, Shaanxi, China
Shanghai Oriental Hospital
Shanghai, Shanghai Municipality, China
The Fifth People's Hospital, Shanghai
Shanghai, Shanghai Municipality, China
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine，Chongming Branch
Shanghai, Shanghai Municipality, China
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ZS-05
Identifier Type: -
Identifier Source: org_study_id
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