Status:
UNKNOWN
Efficacy and Safety of Vitamin D in the Treatment of OAB-wet in Children
Lead Sponsor:
Xing Liu
Conditions:
Urinary Bladder, Overactive
Overactive Bladder
Eligibility:
All Genders
5-18 years
Phase:
NA
Brief Summary
The purpose of this clinical trial is to investigate whether standard behavioral therapy combined with high-dose vitamin D (2400iu daily) is superior to standard behavioral therapy alone and standard ...
Detailed Description
\[Study Objective\]. Primary objective: to investigate whether standard behavioral therapy combined with high-dose vitamin D (2400iu per day) is superior to standard behavioral therapy alone and stand...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 3 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 15 2024
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06201013
Start Date
September 3 2023
End Date
October 15 2024
Last Update
January 11 2024
Active Locations (1)
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1
Children's Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China, 400000