Phase II Clinical Trial of Vitamin D3 for Reducing Recurrence of Recurrent Lower Urinary Tract Infections
Phase II Clinical Trial of Vitamin D3 for Reducing Recurrence of Recurrent Lower Urinary Tract Infections
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.
Inclusion Criteria:

 -  A history of at least 2 symptomatic lower UTI episodes in the previous 6 months or 3
 episodes in the previous 12 months

 -  The symptoms of latest lower UTI episode have disappeared after treatment, without
 antibiotics of treatment dose and the mid-stage urinary bacterial culture <10^5 CFU/mL
 and/or urinary white blood cell count <5/HP or 25/μL

 -  Understand and sign informed consent

 Exclusion Criteria:

 -  Pregnant women, lactating women and uncontraceptive women

 -  Patients with history of arteriosclerosis, cardiac insufficiency, hypercholesterolemia
 or hyperphosphatemia

 -  Diabetic patients with HBA1C > 7%

 -  Patients with other diseases or malformation of urinary tract

 -  Patients with eGFR<30 mL/min/1.73m^2, dialysis or kidney transplantation

 -  Patients with liver disfunction

 -  Patients with vitamin D contraindications

 -  Patients who have participated in any clinical trial in the past 3 months