Using high-dose vitamin D to treat overactive bladder in children

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the efficacy and safety of high-dose vitamin D (2400iu daily) combined with standard behavioral therapy in treating children with wet overactive bladder (OAB). It compares this approach to standard behavioral therapy alone and to a combination of behavioral therapy with solifenacin medication. The study aims to assess improvements in urinary incontinence frequency and lower urinary tract symptoms, while also exploring the relationship between vitamin D levels and these symptoms. Participants will be randomized into three groups to evaluate the effectiveness and safety of the interventions.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Children older than or equal to 5 years of age with a diagnosis of wet OAB (the diagnosis followed the latest guidelines of ICCS) attending the outpatient clinic of the Department of Urology of the Affiliated Children's Hospital of Chongqing Medical University,
* children with serum vitamin D levels below 35 ng/ml as indicated by the tests conducted by the hospital
* children whose guardians have given their informed consent, are able to ensure compliance and have signed a paper-based informed consent form.

Exclusion Criteria:

* Those with urinary malformations or serious diseases (e.g., hypospadias, cryptorchidism, posterior urethral valvulae, vesicoureteral reflux, neurogenic bladder, urinary tumors, urinary stones, bladder and urethral injuries, etc.)
* Those with neurological disorders (e.g., epilepsy, spinal cord injuries, spinal dysplasia, spinal embolism syndrome, multiple sclerosis, and autism spectrum disorders, etc.)
* People with serious heart disease, abnormal liver and kidney function, lung disease, bone deformity, serious digestive tract disease, genetic metabolic disease
* People with history of gastrointestinal surgery and urological surgery
* People with dry stools and long-term constipation
* People who are taking anticonvulsant and antiepileptic drugs, hormones, and anti-tuberculosis drugs
* People with history of hypercalcemia, hyperphosphatemia with renal rickets
* People who have had unexplained hematuria and hematuria with renal rickets within the last year
* People who have been suffering from severe heart disease or chronic diabetes.
* participation in other clinical studies at the time of consultation or during the follow-up period of other clinical studies
* unwillingness to participate in this study

Where it's running

• Children's Hospital of Chongqing Medical University
  Chongqing, Chongqing Municipality, China Recruiting

Study contacts

• Study coordinator: Xing Liu
• Email: CHS_1900@163.com
• Phone: 18725665020

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.