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

NCT04859621 | Unknown Phase 2

• 1 other identifier: ZS-05
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 6

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).

Conditions

Recurrent Urinary Tract Infection

Keywords

Vitamin D3; Recurrent lower urinary tract infection

Outcome Measures

Primary Outcomes (1)

• UTI recurrent incidence in 48 weeks

  UTI episodes during 48-week treatment for each subject

  48 weeks

Secondary Outcomes (3)

• Recurrence rate of UTI in 48 weeks

  48 weeks

• UTI-free duration in 48 weeks

  48 weeks

• Cumulative relapse-free ratio

  48 weeks

Other Outcomes (4)

• Antibiotic treatment during the recurrence of UTI

  48 weeks

• Symptom score of each episode of recurrent lower urinary tract infection

  48 weeks

• Urinary culture bacterial count

  48 weeks

Study Arms (3)

Vitamin D3 4000 IU

EXPERIMENTAL

4000IU Vitamin D3 Oral Tablet plus standard antibiotic therapy

Drug: Vitamin D3 4000 IU; Other: standard antibiotic therapy

Vitamin D3 2000 IU

EXPERIMENTAL

2000IU Vitamin D3 Oral Tablet plus standard antibiotic therapy

Drug: Vitamin D3 2000 IU; Other: standard antibiotic therapy

Placebo

PLACEBO COMPARATOR

Placebo Oral Tablet plus standard antibiotic therapy

Drug: Placebo; Other: standard antibiotic therapy

Interventions

Vitamin D3 4000 IU DRUG

Oral administration, 2 tablet per time, qd, oral administration with the first meal, continuous use for 48 weeks

Vitamin D3 4000 IU

Vitamin D3 2000 IU DRUG

Oral administration, 1 tablet of each per time, qd, oral administration with the first meal, continuous use for 48 weeks

Vitamin D3 2000 IU

Placebo DRUG

Oral administration, 2 tablet per time, qd, oral administration with the first meal, continuous use for 48 weeks

Placebo

standard antibiotic therapy OTHER

standard antibiotic therapy

Placebo; Vitamin D3 2000 IU; Vitamin D3 4000 IU

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Zensun Sci. & Tech. Co., Ltd.: lead

Study Sites (6)

The First Affiliated Hospital of Xi 'an Jiaotong University

Xi'an, Shaanxi, China

RECRUITING

Shanghai Oriental Hospital

Shanghai, Shanghai Municipality, China

RECRUITING

The Fifth People's Hospital, Shanghai

Shanghai, Shanghai Municipality, China

RECRUITING

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

Shanghai, Shanghai Municipality, China

RECRUITING

Sichuan Provincial People's Hospital

Chengdu, Sichuan, China

RECRUITING

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, 200025, China

RECRUITING

MeSH Terms

Conditions

Urinary Tract Infections

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Xian He, MD

  Zhejiang Provincial People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Debing Jiang

CONTACT

86-21-50802627; dbjiang@zensun.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A multicenter, randomized, double-blind, placebo-controlled trial

Study Record Dates

• First Submitted: April 21, 2021
• First Posted: April 26, 2021
• Study Start: May 8, 2021
• Primary Completion: April 30, 2025
• Study Completion: July 30, 2025
• Last Updated: February 2, 2024

Record last verified: 2024-01

Locations

CN (6)