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COMPLETEDNA

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

NCT06489951•Xing Liu

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

Age

5 - 18 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

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

Exclusion Criteria

•1. Patients with other urinary system malformations or serious diseases (such as hypospadias, cryptorchidism, posterior urethral valvular disease, vesicoureteral reflux, neurogenic bladder, urinary system tumors, urinary calculi, bladder and urethral injuries, etc.);
•2. complicated with neurological diseases (such as epilepsy, spinal cord injury, spinal cord dysplasia, tethered cord syndrome, multiple sclerosis, autism spectrum disorder, etc.);
•3. Patients with severe heart disease, abnormal liver and kidney function, lung disease, bone malformation, severe digestive tract disease, and genetic metabolic disease;
•4. History of gastrointestinal surgery and urinary system surgery;
•5. Dry stool, long-term constipation;
•6. are taking anticonvulsant and antiepileptic drugs, hormones, antituberculosis drugs;
•7. Previous history of hypercalcemia, hyperphosphatemia with renal rickets;
•8. History of unexplained hematuria and urinary tract infection in the past 1 year;
•9. Have a history of allergy or allergic reaction to vitamin D preparations;
•10. Participating in another clinical study at the time of visit or during the follow-up of another clinical study;
+1 more criteria

Locations (1)

Children's Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Key Dates

Start Date

December 28, 2024

Primary Completion Date

June 30, 2025

Completion Date

July 3, 2025

Last Updated

November 25, 2025

Enrollment

180

ACTUAL participants

Conditions

Overactive BladderPediatric Disorder

Interventions

Solifenacin

DRUG

vitamin D

DIETARY_SUPPLEMENT

Standard behavioral therapy

BEHAVIORAL

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RECRUITINGNA

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RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 25, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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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

Inclusion Criteria

Exclusion Criteria

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