Actively Recruiting

Phase Not Applicable
Age: 5Years - 18Years
All Genders
NCT06201013

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

Led by Children's Hospital of Chongqing Medical University · Updated on 2026-04-17

180

Participants Needed

1

Research Sites

51 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 5Years - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Children aged 5 to 18 years diagnosed with wet overactive bladder
  • Serum vitamin D levels below 35 ng/ml
  • Informed consent signed by guardians who can ensure compliance
Not Eligible

You will not qualify if you...

  • Urinary malformations or serious urinary diseases such as hypospadias or vesicoureteral reflux
  • Neurological disorders including epilepsy, spinal cord injuries, or autism spectrum disorders
  • Serious heart, liver, kidney, lung, bone, digestive, or genetic metabolic diseases
  • History of gastrointestinal or urological surgery
  • Chronic constipation or dry stools
  • Use of anticonvulsant, antiepileptic, hormone, or anti-tuberculosis medications
  • History of hypercalcemia, hyperphosphatemia with renal rickets
  • Recent unexplained hematuria
  • Severe heart disease or chronic diabetes
  • Participation in other clinical studies during this study
  • Unwillingness to participate in the trial

AI-Screening

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Trial Site Locations

Total: 1 location

1

Children's Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China, 400000

Actively Recruiting

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Research Team

X

Xing Liu

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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