Treatment for dry overactive bladder in children using vitamin D and behavioral therapy

Efficacy and Safety of Short-term High-dose Vitamin D Supplementation Combined With Standard Behavioral Therapy for the Treatment of Dry Overactive Bladder in Children: a Prospective, Randomized Controlled, Multicentre Clinical Study

This study is testing if giving high-dose vitamin D along with behavioral therapy can help children with dry overactive bladder feel better.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 180 (estimated)
• Ages: 5 Years to 18 Years
• Sex: All
• Sponsor: Children's Hospital of Chongqing Medical University (Academic / other)
• Locations: 1 site (Chongqing, Chongqing)
• Trial ID: NCT06489951 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the efficacy and safety of combining standard behavioral therapy with either classical anticholinergic drugs or high-dose vitamin D supplementation in children diagnosed with dry overactive bladder (OAB). Children over the age of 5 with low serum vitamin D levels will be enrolled and monitored for improvements in lower urinary tract symptoms. The goal is to provide evidence supporting the use of vitamin D supplements as a viable treatment option alongside behavioral therapy for this condition in pediatric patients.

Who should consider this trial

Good fit: Ideal candidates are children older than 5 years with a diagnosis of dry overactive bladder and low serum vitamin D levels.

Not a fit: Patients with other urinary system malformations or serious diseases, as well as those with neurological disorders, may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could offer a new effective treatment option for children suffering from dry overactive bladder.

How similar studies have performed: While the combination of vitamin D supplementation with behavioral therapy is a novel approach, similar studies have shown promise in other pediatric conditions, suggesting potential for success.

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

Where this trial is running

Chongqing, Chongqing

• Children's Hospital of Chongqing Medical University — Chongqing, Chongqing, China (Recruiting)

Study contacts

• Study coordinator: Qiu Li, Doctor

Conditions Overactive Bladder; Pediatric Disorder