Using high-dose vitamin D to treat overactive bladder in children
Efficacy, Neural Repair Mechanism, and Health Economics of a Multimodal Treat-to-Target Strategy Incorporating Vitamin D for Pediatric Overactive Bladder-Wet: A Randomized Controlled Trial
This study is testing if giving high-dose vitamin D along with regular therapy can help children with wet overactive bladder feel better compared to just therapy or therapy with a medication.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 5 Years to 18 Years |
| Sex | All |
| Sponsor | Children's Hospital of Chongqing Medical University Academic / other |
| Locations | 1 site (Chongqing, Chongqing Municipality) |
| Trial ID | NCT06201013 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are children aged 5 and older diagnosed with wet OAB and having low serum vitamin D levels.
Not a fit: Patients with urinary malformations, serious diseases, or neurological disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option that improves urinary incontinence and quality of life for children with wet OAB.
How similar studies have performed: While the combination of vitamin D with behavioral therapy is a novel approach, previous studies have shown potential benefits of vitamin D in various conditions, suggesting a promising avenue for exploration.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Chongqing, Chongqing Municipality
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.