NCT05709990

Efficacy and Safety of High Dose Vitamin D Supplementation for Overactive Bladder Dry in Children

Efficacy and Safety of High Dose Vitamin D Supplementation for Overactive Bladder Dry in Children: A Randomized Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 303 (actual)
• Sponsor: Xing Liu · Academic / Other
• Sex: All
• Age: 5 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

This prospective, randomized, 3-arms, parallel-design, controlled clinical trial is conducted to determine whether high dose vitamin D supplementation (combined with standard urotherapy ) improves outcomes, compared with solifenacin (combined with standard urotherapy ) ,and standard urotherapy alone in children with OAB dry.

Detailed description

Overactive bladder(OAB), characterized as urinary urgency accompanied in many instances by frequency and sometimes nocturia, with or without urinary incontinence, in the absence of urinary tract infection or other documented pathology, is a common clinical entity in pediatric urology. The majority of patients with OAB do not experience incontinence yet suffer from symptoms of urgency, frequency, and nocturia, which has been termed OAB dry. Currently, standard urotherapy is proposed as the first-line therapeutic options and adjunctive anticholinergics are usually used when urotherapy alone failed. Behavioral therapy often fail to achieve satisfied symptom control as children's poor compliance. In addition,adverse side effects such as dry mouth, constipation, gastro-oesophageal reflux result in early pharmacologic treatment discontinuation. It was informed that patients with OAB are more likely to suffer from vitamin D deficiency. The aim of the study is to determine the effect of vitamin D supplementation as an adjunctive therapy to behavioral therapy in the treatment of OAB dry. Eligible patients aged 5-18 years with a diagnosis of OAB dry will be randomly assigned into three groups to receive high dose vitamin D supplementation (combined with standard urotherapy ) , solifenacin (combined with standard urotherapy ) or standard urotherapy alone. Serum levels of 25(OH)D will be measured at baseline. Symptoms severity will be assessed at baseline and followup. All the other sociodemographic data will be also assessed. The study will give more information on the application of vitamin D supplementation in the management of OAB dry.

Conditions

• Overactive Bladder

Interventions

Type	Name	Description
DRUG	Solifenacin Succinate 5 MG Oral Tablet [Vesicare]	These patients will receive solifenacin 5-10 MG daily (combined with standard urotherapy) for 8 weeks.
DRUG	Vitamin D3	These patients will receive high dose vitamin D supplementation (more than 2000IU daily) (combined with standard urotherapy) for 8 weeks.
BEHAVIORAL	Standard urotherapy	These patients will receive standard urotherapyfor 8 weeks.

Timeline

• Start date: 2023-01-15
• Primary completion: 2023-06-03
• Completion: 2023-06-15
• First posted: 2023-02-02
• Last updated: 2024-02-06

Locations

1 site across 1 country: China