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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

NCT06489951 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2025-11-25

No results posted yet for this 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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Beijing Children's Hospital

    collaborator OTHER

  • Shanghai Children's Hospital

    collaborator OTHER

  • Children's Hospital of Soochow University

    collaborator OTHER

  • Guizhou Provincial People's Hospital

    collaborator OTHER

  • Xing Liu

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-28
Primary Completion
2025-06-30
Completion
2025-07-03

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06489951 on ClinicalTrials.gov