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

NCT ID: NCT06489951

Last Updated: 2025-11-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-28
• Study Completion Date: 2025-07-03

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Standard Behavioral Therapy Combined with Solifenacin Drug Treatment

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

Group Type: EXPERIMENTAL

Solifenacin

Intervention Type: DRUG

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

Standard behavioral therapy

Intervention Type: 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 short-term high dose exogenous vitamin D supplementation

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

Group Type: EXPERIMENTAL

vitamin D

Intervention Type: DIETARY_SUPPLEMENT

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

Standard behavioral therapy

Intervention Type: 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

Interventions

Solifenacin

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

Intervention Type: DRUG

vitamin D

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

Intervention Type: DIETARY_SUPPLEMENT

Standard behavioral therapy

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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;

11. Those who did not want to participate in the study or had poor follow-up compliance

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Children's Hospital

OTHER

Sponsor Role: collaborator

Shanghai Children's Hospital

OTHER

Sponsor Role: collaborator

Children's Hospital of Soochow University

OTHER

Sponsor Role: collaborator

Guizhou Provincial People's Hospital

OTHER

Sponsor Role: collaborator

Xing Liu

OTHER

Sponsor Role: lead

Responsible Party

Xing Liu

Professor, Doctor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Children's Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Countries

China

Other Identifiers

202453

Identifier Type: -

Identifier Source: org_study_id