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).
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
150
Oral administration, 2 tablet per time, qd, oral administration with the first meal, continuous use for 48 weeks
Oral administration, 1 tablet of each per time, qd, oral administration with the first meal, continuous use for 48 weeks
Oral administration, 2 tablet per time, qd, oral administration with the first meal, continuous use for 48 weeks
The First Affiliated Hospital of Xi 'an Jiaotong University
Xi'an, Shaanxi, China
RECRUITINGShanghai Oriental Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGThe Fifth People's Hospital, Shanghai
Shanghai, Shanghai Municipality, China
UTI recurrent incidence in 48 weeks
UTI episodes during 48-week treatment for each subject
Time frame: 48 weeks
Recurrence rate of UTI in 48 weeks
Comparing the recurrence rate of UTI between different treatment groups
Time frame: 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.
Time frame: 48 weeks
Cumulative relapse-free ratio
Ratio of the cumulative duration of UTI-free period to treatment duration
Time frame: 48 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
standard antibiotic therapy
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine,Chongming Branch
Shanghai, Shanghai Municipality, China
RECRUITINGSichuan Provincial People's Hospital
Chengdu, Sichuan, China
RECRUITINGZhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China
RECRUITING