Phase II Clinical Trial of Vitamin D3 for Reducing Recurrence of Recurrent Lower Urinary Tract Infections
Primary Purpose
Recurrent Urinary Tract Infection
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Vitamin D3 4000 IU
Vitamin D3 2000 IU
Placebo
standard antibiotic therapy
Sponsored by
About this trial
This is an interventional treatment trial for Recurrent Urinary Tract Infection focused on measuring Vitamin D3, Recurrent lower urinary tract infection
Eligibility Criteria
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 have disappeared 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 urinary bacterial culture is less than 10^5 CFU/mL (accept the examination results after the last improvement);B) Urine white blood cell count is less than 5 /HP, and if it can be measured in routine urine examination, it should be less than 25 /μL;
- Signed written informed consent;
- Be able to follow the research protocol.
Exclusion Criteria:
- Complicated with cardio-cerebrovascular and hematopoietic system and other serious primary diseases;
- Poor glycemic control (HbA1c >7.5%) with diabetes;
- Patients with genital tract malformation or acute genital tract infection and genital tract 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 urethral catheterization, 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 kidney transplantation patients;
- Chronic liver disease may have potential influence on liver function (bilirubin >;1.5 times upper limit of normal value, aspartate aminotransferase or alanine aminotransferase >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 small intestine, such as Crohn's disease;
- receiving immunosuppressive agents or GT;10 mg/d glucocorticoids;
- had received any other investigational drug therapy or participated in another interventional 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 (women of child-bearing age are defined as all women with physical ability to become pregnant), or women who are pregnant or lactating;
- Circumstances in which subjects are judged by the investigator to be unsuitable for inclusion.
Sites / Locations
- The First Affiliated Hospital of Xi 'an Jiaotong UniversityRecruiting
- Shanghai Ruijin HospitalRecruiting
- Shanghai Oriental HospitalRecruiting
- The Fifth People's Hospital, ShanghaiRecruiting
- Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine,Chongming BranchRecruiting
- Sichuan Provincial People's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Vitamin D3 4000 IU
Vitamin D3 2000 IU
Placebo
Arm Description
4000IU Vitamin D3 Oral Tablet plus standard antibiotic therapy
2000IU Vitamin D3 Oral Tablet plus standard antibiotic therapy
Placebo Oral Tablet plus standard antibiotic therapy
Outcomes
Primary Outcome Measures
UTI recurrent incidence in 48 weeks
UTI episodes during 48-week treatment for each subject
Secondary Outcome Measures
Recurrence rate of UTI in 48 weeks
Comparing the recurrence rate of UTI between different treatment groups
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.
Cumulative relapse-free ratio
Ratio of the cumulative duration of UTI-free period to treatment duration
Full Information
NCT ID
NCT04859621
First Posted
April 21, 2021
Last Updated
July 13, 2021
Sponsor
Zensun Sci. & Tech. Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04859621
Brief Title
Phase II Clinical Trial of Vitamin D3 for Reducing Recurrence of Recurrent Lower Urinary Tract Infections
Official Title
Phase II Clinical Trial of Vitamin D3 for Reducing Recurrence of Recurrent Lower Urinary Tract Infections: a Multicenter, Randomized, Placebo-controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 8, 2021 (Actual)
Primary Completion Date
April 30, 2023 (Anticipated)
Study Completion Date
July 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zensun Sci. & Tech. Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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).
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Urinary Tract Infection
Keywords
Vitamin D3, Recurrent lower urinary tract infection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
A multicenter, randomized, double-blind, placebo-controlled trial
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
To ensure that the randomized drug treatment period is double-blind, the study drug and placebo control have the same appearance, smell, and taste. Furthermore, the package and label are also adjusted correspondingly to ensure blindness.
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Vitamin D3 4000 IU
Arm Type
Experimental
Arm Description
4000IU Vitamin D3 Oral Tablet plus standard antibiotic therapy
Arm Title
Vitamin D3 2000 IU
Arm Type
Experimental
Arm Description
2000IU Vitamin D3 Oral Tablet plus standard antibiotic therapy
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo Oral Tablet plus standard antibiotic therapy
Intervention Type
Drug
Intervention Name(s)
Vitamin D3 4000 IU
Intervention Description
Oral administration, 2 tablet per time, qd, oral administration with the first meal, continuous use for 48 weeks
Intervention Type
Drug
Intervention Name(s)
Vitamin D3 2000 IU
Intervention Description
Oral administration, 1 tablet of each per time, qd, oral administration with the first meal, continuous use for 48 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral administration, 2 tablet per time, qd, oral administration with the first meal, continuous use for 48 weeks
Intervention Type
Other
Intervention Name(s)
standard antibiotic therapy
Intervention Description
standard antibiotic therapy
Primary Outcome Measure Information:
Title
UTI recurrent incidence in 48 weeks
Description
UTI episodes during 48-week treatment for each subject
Time Frame
48 weeks
Secondary Outcome Measure Information:
Title
Recurrence rate of UTI in 48 weeks
Description
Comparing the recurrence rate of UTI between different treatment groups
Time Frame
48 weeks
Title
UTI-free duration in 48 weeks
Description
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
Title
Cumulative relapse-free ratio
Description
Ratio of the cumulative duration of UTI-free period to treatment duration
Time Frame
48 weeks
Other Pre-specified Outcome Measures:
Title
Antibiotic treatment during the recurrence of UTI
Description
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
Title
Symptom score of each episode of recurrent lower urinary tract infection
Description
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
Title
Urinary culture bacterial count
Description
Urinary culture bacterial count at each recurrence of UTI
Time Frame
48 weeks
Title
Blood and urine levels of antimicrobial peptides
Description
Blood and urine levels of antimicrobial peptides at planned and additional visits
Time Frame
48 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 have disappeared 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 urinary bacterial culture is less than 10^5 CFU/mL (accept the examination results after the last improvement);B) Urine white blood cell count is less than 5 /HP, and if it can be measured in routine urine examination, it should be less than 25 /μL;
Signed written informed consent;
Be able to follow the research protocol.
Exclusion Criteria:
Complicated with cardio-cerebrovascular and hematopoietic system and other serious primary diseases;
Poor glycemic control (HbA1c >7.5%) with diabetes;
Patients with genital tract malformation or acute genital tract infection and genital tract 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 urethral catheterization, 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 kidney transplantation patients;
Chronic liver disease may have potential influence on liver function (bilirubin >;1.5 times upper limit of normal value, aspartate aminotransferase or alanine aminotransferase >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 small intestine, such as Crohn's disease;
receiving immunosuppressive agents or GT;10 mg/d glucocorticoids;
had received any other investigational drug therapy or participated in another interventional 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 (women of child-bearing age are defined as all women with physical ability to become pregnant), or women who are pregnant or lactating;
Circumstances in which subjects are judged by the investigator to be unsuitable for inclusion.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaorui Wang, Ph.D
Phone
86-21-50802627
Ext
196
Email
wangxiaorui@zensun.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nan Chen, MD
Organizational Affiliation
Ruijin Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Affiliated Hospital of Xi 'an Jiaotong University
City
Xi'an
State/Province
Shaanxi
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aiping Yin
Phone
18991232130
Email
aipingy@126.com
Facility Name
Shanghai Ruijin Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200025
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nan Chen, MD
Phone
13601638963
Email
cnrj100@126.com
Facility Name
Shanghai Oriental Hospital
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Na Liu
Phone
18217768587
Email
naliubrown@163.com
Facility Name
The Fifth People's Hospital, Shanghai
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianying Niu
Phone
18918168518
Email
njyphd2008@163.com
Facility Name
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine,Chongming Branch
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chun Zhu
Phone
13611951773
Email
zhuchun26@sina.cn
Facility Name
Sichuan Provincial People's Hospital
City
Chengdu
State/Province
Sichuan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li Wang
Phone
13708016939
Email
scwangli62@163.com
12. IPD Sharing Statement
Learn more about this trial
Phase II Clinical Trial of Vitamin D3 for Reducing Recurrence of Recurrent Lower Urinary Tract Infections
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