NCT06489951

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 180 (actual)
• Sponsor: Xing Liu · Academic / Other
• Sex: All
• Age: 5 Years – 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Solifenacin	The outpatient physician prescribed Solinaxine (up to 0.5mg daily) to the participant orally
DIETARY_SUPPLEMENT	vitamin D	The outpatient physician prescribed vitamin d drops (2400iu daily) for the participants, which were taken orally by the participants
BEHAVIORAL	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

Timeline

• Start date: 2024-12-28
• Primary completion: 2025-06-30
• Completion: 2025-07-03
• First posted: 2024-07-08
• Last updated: 2025-11-25

Locations

1 site across 1 country: China