Phase II Clinical Trial of Vitamin D3 for Reducing Recurrence of Recurrent Lower Urinary Tract Infections

Last updated: January 31, 2024
Sponsor: Zensun Sci. & Tech. Co., Ltd.
Overall Status: Active - Recruiting

Phase

2

Condition

Urinary Tract Infections

Treatment

standard antibiotic therapy

Vitamin D3 2000 IU

Placebo

Clinical Study ID

NCT04859621
ZS-05
  • Ages 18-75
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

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 havedisappeared 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 urinarybacterial culture is less than 10^5 CFU/mL (accept the examination results after thelast improvement);B) Urine white blood cell count is less than 5 /HP, and if it can bemeasured 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

Exclusion Criteria:

  1. Complicated with cardio-cerebrovascular and hematopoietic system and other seriousprimary diseases;
  2. Poor glycemic control (HbA1c >7.5%) with diabetes;
  3. Patients with genital tract malformation or acute genital tract infection and genitaltract 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 urethralcatheterization, 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 kidneytransplantation patients;
  8. Chronic liver disease may have potential influence on liver function (bilirubin >;1.5times upper limit of normal value, aspartate aminotransferase or alanineaminotransferase >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 smallintestine, 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 anotherinterventional 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 (womenof child-bearing age are defined as all women with physical ability to becomepregnant), or women who are pregnant or lactating;
  15. Circumstances in which subjects are judged by the investigator to be unsuitable forinclusion.

Study Design

Total Participants: 150
Treatment Group(s): 4
Primary Treatment: standard antibiotic therapy
Phase: 2
Study Start date:
May 08, 2021
Estimated Completion Date:
July 30, 2025

Study 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.

Connect with a study center

  • The First Affiliated Hospital of Xi 'an Jiaotong University

    Xi'an, Shaanxi
    China

    Active - Recruiting

  • Shanghai Oriental Hospital

    Shanghai, Shanghai
    China

    Active - Recruiting

  • Shanghai Ruijin Hospital

    Shanghai, Shanghai 200025
    China

    Active - Recruiting

  • The Fifth People's Hospital, Shanghai

    Shanghai, Shanghai
    China

    Active - Recruiting

  • Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine,Chongming Branch

    Shanghai, Shanghai
    China

    Active - Recruiting

  • Sichuan Provincial People's Hospital

    Chengdu, Sichuan
    China

    Active - Recruiting

  • Zhejiang Provincial People's Hospital

    Hangzhou, Zhejiang 200025
    China

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.