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
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Male or female aged 18 to 75 years, including 18 and 75 years;
- 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;
- 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;
- Signed written informed consent;
- Be able to follow the research protocol.
Exclusion
Exclusion Criteria:
- Complicated with cardio-cerebrovascular and hematopoietic system and other seriousprimary diseases;
- Poor glycemic control (HbA1c >7.5%) with diabetes;
- Patients with genital tract malformation or acute genital tract infection and genitaltract tumor;
- Patients with urinary system tuberculosis and acute pyelonephritis;
- Patients with cysto-ureteral reflux or urethral reflux;
- 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;
- Glomerular filtration rate (MDRD formula).20 mL/min/1.73m2, dialysis or kidneytransplantation patients;
- 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);
- Patients with vitamin D3 contraindications, such as hypercalcemia, hypervitaminism,hyperphosphatemia with renal rickets, etc.;
- Patients with diseases that affect the absorption of vitamin D3 in the smallintestine, such as Crohn's disease;
- receiving immunosuppressive agents or GT;10 mg/d glucocorticoids;
- had received any other investigational drug therapy or participated in anotherinterventional clinical trial within 30 days prior to screening;
- Have a history of alcohol or drug abuse or suffer from mental illness;
- 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;
- 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
Connect with a study center
The First Affiliated Hospital of Xi 'an Jiaotong University
Xi'an, Shaanxi
ChinaActive - Recruiting
Shanghai Oriental Hospital
Shanghai, Shanghai
ChinaActive - Recruiting
Shanghai Ruijin Hospital
Shanghai, Shanghai 200025
ChinaActive - Recruiting
The Fifth People's Hospital, Shanghai
Shanghai, Shanghai
ChinaActive - Recruiting
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine,Chongming Branch
Shanghai, Shanghai
ChinaActive - Recruiting
Sichuan Provincial People's Hospital
Chengdu, Sichuan
ChinaActive - Recruiting
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang 200025
ChinaActive - Recruiting
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