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 | Completed

• 1 other identifier: 202453
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Overactive Bladder; Pediatric Disorder

Outcome Measures

Primary Outcomes (1)

• Change in daily urination frequency

  To explore whether standard behavioral therapy combined with short-term high dose vitamin D (2400IU daily) is superior to standard behavioral therapy combined with anticholinergic drugs (Solinaxine) in improving the daily frequency of urination in children with dry OAB.

  week 1, week6，week 12

Secondary Outcomes (2)

• Change in the mean urgency score

  week 1, week6，week 12

• Change quality of life score

  week 1, week6，week 12

Study Arms (2)

Standard Behavioral Therapy Combined with Solifenacin Drug Treatment

EXPERIMENTAL

Solinasine succinate 5mg once daily with a maximum dose of 10mg/day. Standard Behavioral Therapy

Drug: Solifenacin; Behavioral: Standard behavioral therapy

Standard behavioral therapy combined with short-term high dose exogenous vitamin D supplementation

EXPERIMENTAL

Oral vitamin D drops, 2400iu/d, continued for 6 weeks after follow-up. Standard Behavioral Therapy

Dietary Supplement: vitamin D; Behavioral: Standard behavioral therapy

Interventions

Solifenacin DRUG

The outpatient physician prescribed Solinaxine (up to 0.5mg daily) to the participant orally

Standard Behavioral Therapy Combined with Solifenacin Drug Treatment

vitamin D DIETARY_SUPPLEMENT

The outpatient physician prescribed vitamin d drops (2400iu daily) for the participants, which were taken orally by the participants

Standard behavioral therapy combined with short-term high dose exogenous vitamin D supplementation

Standard behavioral therapy BEHAVIORAL

Participants will receive an initial behavioral therapy session at enrollment and a second behavioral therapy session six weeks later. Education including information about dry OAB, lifestyle adjustments, bladder and pelvic floor training, bowel management, and how to use a bladder diary to record urination

Standard Behavioral Therapy Combined with Solifenacin Drug Treatment; Standard behavioral therapy combined with short-term high dose exogenous vitamin D supplementation

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.
• The results of our laboratory indicated that the serum vitamin D level was lower than 35ng/mL.
• 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.

You may not qualify if:

• 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.);
• complicated with neurological diseases (such as epilepsy, spinal cord injury, spinal cord dysplasia, tethered cord syndrome, multiple sclerosis, autism spectrum disorder, etc.);
• Patients with severe heart disease, abnormal liver and kidney function, lung disease, bone malformation, severe digestive tract disease, and genetic metabolic disease;
• 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-up of another clinical study;
• Those who did not want to participate in the study or had poor follow-up compliance

Sponsors & Collaborators

• Xing Liu: lead
• Beijing Children's Hospital: collaborator
• Shanghai Children's Hospital: collaborator
• Children's Hospital of Soochow University: collaborator
• Guizhou Provincial People's Hospital: collaborator

Study Sites (1)

Children's Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400000, China

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

Solifenacin Succinate; Vitamin D

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds; Tetrahydroisoquinolines; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, Doctor

Study Record Dates

• First Submitted: June 24, 2024
• First Posted: July 8, 2024
• Study Start: December 28, 2024
• Primary Completion: June 30, 2025
• Study Completion: July 3, 2025
• Last Updated: November 25, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)