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Vitamin D Treat-to-Target Strategy for Children With Overactive Bladder-Wet

StatusRecruiting
PhaseNot applicable
Started
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Record status
This record was last updated April 17, 2026 (before its estimated September 15, 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Notable Lead sponsor: Xing Liu to Children's Hospital of Chongqing Medical Universityv2 Show 9 more changesShow less
    • Primary completion date: Sep 15, 2024 to Sep 15, 2026
    • Start date: Sep 3, 2023 to Apr 20, 2026
    • Primary endpoints: 2 to 1
    • Enrollment target: 150 to 180
    • Study completion date: Oct 15, 2024 to Apr 15, 2027
    • Secondary endpoints: 2 to 5
    • Study description shortened, about 104 words
    • Study arms: 3 to 2
    • Study title shortened, about 4 words
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The purpose of this clinical trial is to investigate whether adding high-dose vitamin D (2,400 IU daily) to standard medical treatment (solifenacin combined with behavioral therapy) is more effective than standard treatment alone for children with overactive bladder-wet (OAB-wet). OAB-wet causes sudden urinary urges and frequent daytime or incontinence, which significantly impacts a child's quality of life and increases the family's caregiving burden. While solifenacin is a standard medication used to calm the bladder, many children do not achieve complete dryness. This study introduces the "Treat-to-Target" (T2T) approach, where clinicians and families set personalized "functional goals" (such as zero leakage) and monitor progress closely to adjust care. The study aims to answer the following questions: Does adding vitamin D help more children achieve their goal of "zero leakage" compared to standard treatment? Does vitamin D help repair bladder-related nerves, as measured by a specific marker in the urine? Does this combined approach reduce the family's expenses (like laundry costs and diaper use) and improve the child's self-esteem? Participants will be randomly assigned to one of two groups for 12 weeks: Intervention Group: Standard care (solifenacin + behavioral therapy) plus daily vitamin D (2,400 IU). Control Group: Standard care (solifenacin + behavioral therapy) alone. Researchers will evaluate symptoms, vitamin D levels, and nerve repair markers at 6 and 12 weeks to determine the best treatment strategy for these children.
Trial Details
NCT Number NCT06201013
Lead Sponsor Children's Hospital of Chongqing Medical University
Conditions
(from sponsor)
Urinary Bladder, Overactive, Overactive Bladder, Urinary Incontinence, Urge
Related terms Urinary Bladder, Overactive, Urinary Incontinence, Urge
Enrollment 180 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov