Efficacy and Safety of Vitamin D in the Treatment of OAB-wet in Children

Launched by XING LIU · Dec 29, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at the effectiveness and safety of using high-dose vitamin D along with standard behavioral therapy to treat children with a condition called wet overactive bladder (OAB). This condition causes frequent urges to urinate and can lead to involuntary leakage. The study will compare three different approaches: standard behavioral therapy alone, standard behavioral therapy with solifenacin (a medication), and standard behavioral therapy with high-dose vitamin D. The goal is to see if adding vitamin D can help improve symptoms more than the other treatments.

To participate in this trial, children must be at least 5 years old and have been diagnosed with wet OAB. They also need to have low vitamin D levels, as determined by tests at the hospital. However, children with certain medical conditions, such as serious urinary or neurological disorders, will not be eligible. If your child qualifies and participates, they will receive one of the three treatment options, and researchers will monitor their progress to see how well the treatments work. This study aims to find better ways to manage wet OAB in children and improve their quality of life.

Gender

ALL

Eligibility 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