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