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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04859621
Other study ID # ZS-05
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date May 8, 2021
Est. completion date July 30, 2025

Study information

Verified date January 2024
Source Zensun Sci. & Tech. Co., Ltd.
Contact Debing Jiang
Phone 86-21-50802627
Email dbjiang@zensun.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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).


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 150
Est. completion date July 30, 2025
Est. primary completion date April 30, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: 1. Male or female aged 18 to 75 years, including 18 and 75 years; 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: 1. Complicated with cardio-cerebrovascular and hematopoietic system and other serious primary diseases; 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
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
Other:
standard antibiotic therapy
standard antibiotic therapy

Locations

Country Name City State
China Sichuan Provincial People's Hospital Chengdu Sichuan
China Zhejiang Provincial People's Hospital Hangzhou Zhejiang
China Shanghai Oriental Hospital Shanghai Shanghai
China The Fifth People's Hospital, Shanghai Shanghai Shanghai
China Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine,Chongming Branch Shanghai Shanghai
China The First Affiliated Hospital of Xi 'an Jiaotong University Xi'an Shaanxi

Sponsors (1)

Lead Sponsor Collaborator
Zensun Sci. & Tech. Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Other Antibiotic treatment during the recurrence of UTI Subjects will be given antibiotics during the recurrence of UTI, type/name and the duration of antibiotic treatment will be compared between different treatment groups. 48 weeks
Other Symptom score of each episode of recurrent lower urinary tract infection Symptom score of each episode of UTI will be evaluated using an overall impression scale with 7 severity levels ( "a" means the best outcome and "g" as the worst outcome.) 48 weeks
Other Urinary culture bacterial count Urinary culture bacterial count at each recurrence of UTI 48 weeks
Other Blood and urine levels of antimicrobial peptides Blood and urine levels of antimicrobial peptides at planned and additional visits 48 weeks
Primary UTI recurrent incidence in 48 weeks UTI episodes during 48-week treatment for each subject 48 weeks
Secondary Recurrence rate of UTI in 48 weeks Comparing the recurrence rate of UTI between different treatment groups 48 weeks
Secondary 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. 48 weeks
Secondary Cumulative relapse-free ratio Ratio of the cumulative duration of UTI-free period to treatment duration 48 weeks
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