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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

303 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-15

Study Completion Date

2023-06-15

Brief Summary

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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.

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Detailed Description

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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

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Overactive Bladder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The 3 groups will be treated at the same time

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

outcome evaluators, and statisticians were blinded.

Study Groups

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High dose vitamin D supplementation (combined with standard urotherapy)

These patients will receive high dose vitamin D supplementation (more than 2000IU daily) and behavioral therapy for 8 weeks

Group Type EXPERIMENTAL

Vitamin D3

Intervention Type DRUG

These patients will receive high dose vitamin D supplementation (more than 2000IU daily) (combined with standard urotherapy) for 8 weeks.

Solifenacin succinate group (combined with standard urotherapy)

These patients will receive solifenacin (5-10 mg daily) and behavioral therapy for 8 weeks

Group Type ACTIVE_COMPARATOR

Solifenacin Succinate 5 MG Oral Tablet [Vesicare]

Intervention Type DRUG

These patients will receive solifenacin 5-10 MG daily (combined with standard urotherapy) for 8 weeks.

standard urotherapy group

These patients will receive behavioral therapy alone for 8 weeks.

Group Type ACTIVE_COMPARATOR

Standard urotherapy

Intervention Type BEHAVIORAL

These patients will receive standard urotherapyfor 8 weeks.

Interventions

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Solifenacin Succinate 5 MG Oral Tablet [Vesicare]

These patients will receive solifenacin 5-10 MG daily (combined with standard urotherapy) for 8 weeks.

Intervention Type DRUG

Vitamin D3

These patients will receive high dose vitamin D supplementation (more than 2000IU daily) (combined with standard urotherapy) for 8 weeks.

Intervention Type DRUG

Standard urotherapy

These patients will receive standard urotherapyfor 8 weeks.

Intervention Type BEHAVIORAL

Other Intervention Names

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standard urotherapy standard urotherapy

Eligibility Criteria

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Inclusion Criteria

1. Children older than 5 years of age with a diagnosis of OAB dry (do not experience incontinence yet suffer from symptoms of urgency, frequency, and nocturia) seen at the outpatient urology clinics (diagnosis follows the latest International Children's Continence Society recommendations).
2. Children with a serum vitamin D level of less than 35 ng/ml as indicated by the laboratory result.
3. Written informed consent was obtained from participants and their parents. -

Exclusion Criteria

1. Those with a comorbidity of other urological abnormalities or serious diseases (e.g. hypospadias, cryptorchidism, posterior urethral valves, vesicoureteral reflux, neurogenic bladder, urological tumours, urinary stones, bladder and urethral injuries, etc.).
2. Those with a comorbidity of neurological disorders (e.g. epilepsy, spinal cord injury, spinal cord dysplasia, spinal cord embolism syndrome, multiple sclerosis, autism spectrum disorder, etc.) .
3. Those with acomorbidity of severe heart disease, abnormal liver or kidney function, lung disease, skeletal deformities, severe gastrointestinal disease, or inherited metabolic disorders.
4. Those with a history of gastrointestinal surgery and urinary tract surgery.
5. Those with chronic constipation.
6. Those taking anticonvulsant and antiepileptic drugs, hormones, anti-tuberculosis drugs.
7. Those have a previous history of hypercalcemia, hyperphosphatemia with renal rickets.
8. Those have a history of haematuria and urinary tract infection within the last 1 year.
9. Those have a history of allergy or allergic disease to vitamin D preparations.
10. Those Participate in other clinical studies at the time of consultation or during the follow-up of other clinical studies.
11. Any condition that could cause urinary symptoms or interfere with assessment of efficacy parameters.
12. Those unwilling to participate in this study. -

Minimum Eligible Age

5 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No