Efficacy and Mechanism of High-Dose Vitamin D Supplementation in Pediatric OAB-Dry: A Randomized Clinical Trial Integrating Urinary Myelin Basic Protein as a Theranostic Biomarker

Phase

N/A

Condition

Enuresis

Overactive Bladder

Treatment

Solifenacin

vitamin D

Standard behavioral therapy

Clinical Study ID

NCT06489951

202453

Ages 5-18
All Genders

Study Summary

The aim of this study is to give children with dry OAB: (1) Standard behavioral therapy combined with classical anticholinergic drugs (Solinaxine), or (2) standard behavioral therapy combined with short-term high-dose exogenous vitamin D supplementation are used to compare the outcomes of lower urinary tract symptoms in children with dry OAB during follow-up. To provide more robust supporting evidence for the broader promotion of short-term high-dose exogenous vitamin D supplements in combination with standard behavioral therapy as an effective treatment for dry OAB treatment in children.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Children older than 5 years who were admitted to the Department of Urology,Children's Hospital Affiliated to Chongqing Medical University and diagnosed withdry OAB.
The results of our laboratory indicated that the serum vitamin D level was lowerthan 35ng/mL.
The child (guardian) has been informed of the nature of the study, understands theprovisions in the protocol, is able to guarantee compliance, and signs the informedconsent.

Exclusion

Exclusion Criteria:

Patients with other urinary system malformations or serious diseases (such ashypospadias, cryptorchidism, posterior urethral valvular disease, vesicoureteralreflux, neurogenic bladder, urinary system tumors, urinary calculi, bladder andurethral injuries, etc.);
complicated with neurological diseases (such as epilepsy, spinal cord injury, spinalcord dysplasia, tethered cord syndrome, multiple sclerosis, autism spectrumdisorder, etc.);
Patients with severe heart disease, abnormal liver and kidney function, lungdisease, bone malformation, severe digestive tract disease, and genetic metabolicdisease;
History of gastrointestinal surgery and urinary system surgery;
Dry stool, long-term constipation;
are taking anticonvulsant and antiepileptic drugs, hormones, antituberculosis drugs;
Previous history of hypercalcemia, hyperphosphatemia with renal rickets;
History of unexplained hematuria and urinary tract infection in the past 1 year;
Have a history of allergy or allergic reaction to vitamin D preparations;
Participating in another clinical study at the time of visit or during the follow-upof another clinical study;
Those who did not want to participate in the study or had poor follow-up compliance

Study Design