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NCT Number: 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

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.

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Key information

Age range

5 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

solifenacin

Drug

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

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

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

Primary outcomes

  1. Change in daily urination frequency

    Time frame: week 1, week6,week 12

    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.

Secondary outcomes

  1. Change in the mean urgency score

    Time frame: week 1, week6,week 12

    To explore whether standard behavioral therapy combined with short-term high dose exogenous vitamin D supplementation (2400IU daily) is superior to standard behavioral therapy combined with anticholinergic drugs (Solinaxine) in improving mean urinal urgency scores in children with dry OAB.

  2. Change quality of life score

    Time frame: week 1, week6,week 12

    Quality of life scores are assessed on a scale of 0 to 3, where 0 indicates no impact on family, social or academic life; A score of 1 represents occasional effects; A score of 2 is a significant impact. A score of 3 indicates a serious impact on family, social or school life

Sponsors and collaborators

Lead sponsor

Xing Liu

Other

Collaborators

  • Beijing Children's Hospital
  • Children's Hospital of Soochow University
  • Guizhou Provincial People's Hospital
  • Shanghai Children's Hospital

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 8, 2024
Registry last updated
Nov 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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