A Phase 2 interventional study of Vitamin D3 4000 IU and Vitamin D3 2000 IU in Recurrent Urinary Tract Infection, sponsored by Zensun Sci. & Tech. Co., Ltd.. Recruiting at 6 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-02-02.
Sponsored by Zensun Sci. & Tech. Co., Ltd. · Phase 2, Interventional, and Treatment
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.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's planned enrollment of 150 is above the median of 120 across 4,200 interventional studies indexed under Infections.
Browse Infections studies →Zensun Sci. & Tech. Co., Ltd. is the lead sponsor of 10 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
4000IU Vitamin D3 Oral Tablet plus standard antibiotic therapy
Drug: Vitamin D3 4000 IU · Other: standard antibiotic therapy
2000IU Vitamin D3 Oral Tablet plus standard antibiotic therapy
Drug: Vitamin D3 2000 IU · Other: standard antibiotic therapy
Placebo Oral Tablet plus standard antibiotic therapy
Drug: Placebo · Other: standard antibiotic therapy
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
standard antibiotic therapy
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
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.
Time frame: 48 weeks
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.)
Time frame: 48 weeks
Urinary culture bacterial count
Urinary culture bacterial count at each recurrence of UTI
Time frame: 48 weeks
Blood and urine levels of antimicrobial peptides
Blood and urine levels of antimicrobial peptides at planned and additional visits
Time frame: 48 weeks
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Zensun Sci. & Tech. Co., Ltd.