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

February 5, 2024 updated by: Xing Liu

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

303

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Chongqing
      • Chongqing, Chongqing, China, 400000
        • Children's Hospital of Chongqing Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

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. -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Drug: Vitamin D3
These patients will receive high dose vitamin D supplementation (more than 2000IU daily) (combined with standard urotherapy) for 8 weeks.
Other Names:
  • standard urotherapy
Active Comparator: Solifenacin succinate group (combined with standard urotherapy)
These patients will receive solifenacin (5-10 mg daily) and behavioral therapy for 8 weeks
Drug: Solifenacin Succinate 5 MG Oral Tablet [Vesicare]
These patients will receive solifenacin 5-10 MG daily (combined with standard urotherapy) for 8 weeks.
Other Names:
  • standard urotherapy
Active Comparator: standard urotherapy group
These patients will receive behavioral therapy alone for 8 weeks.
Behavioral: Standard urotherapy
These patients will receive standard urotherapyfor 8 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in voiding frequency
Time Frame: 8 weeks
Change in voiding frequency as documented in the bladder diaries (voids/d) from baseline to the followup
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in mean nocturia frequency, episodes/night
Time Frame: 8 weeks
Change in mean nocturia frequency from baseline to the followup
8 weeks
Change in vitamin D level
Time Frame: 8 weeks
Change in vitamin D level from baseline to the followup
8 weeks
Global perception of improvement
Time Frame: 8 weeks
Global perception of improvement (much better; better; about the same; worse)
8 weeks
Wish to receive another form of treatment?
Time Frame: 8 weeks
Wish to receive another form of treatment? (YES; No)
8 weeks
Change in mean urgency score
Time Frame: 8 weeks
Change in mean urgency score as documented from baseline to the followup，0 indicated no urgency, 1 indicated mild awareness of urgency that iseasily tolerated, 2 indicated moderate urgency discomfort that interferes with or shortens usual activity, and 3 indicated severe urgency discomfort that abruptly stops all activities or tasks
8 weeks
Change in max urgency score
Time Frame: 8 weeks
Change in max urgency score as documented from baseline to the followup，0 indicated no urgency, 1 indicated mild awareness of urgency that iseasily tolerated, 2 indicated moderate urgency discomfort that interferes with or shortens usual activity, and 3 indicated severe urgency discomfort that abruptly stops all activities or tasks
8 weeks
Change in pediatric lower urinary tract symptom score
Time Frame: 8 weeks
Change in pediatric lower urinary tract symptom score from baseline to the followup， score ranged from 0 to 21 and higher scores indicated a more frequent and severe occurrence of lower urinary tract symptoms.
8 weeks
Change in quality of life score
Time Frame: 8 weeks
The quality of life was assessed using a scale ranging from 0 to 3, where a score of 0 indicated no impact on family, social, or academic life, a score of 1 indicated occasional impact, a score of 2 indicated significant impact, and a score of 3 indicated severe impact on family, social, or academic life.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xing Liu

Investigators

  • Study Director: Xing Liu, Doctor, Children's Hospital of Chongqing Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2023

Primary Completion (Actual)

June 3, 2023

Study Completion (Actual)

June 15, 2023

Study Registration Dates

First Submitted

January 18, 2023

First Submitted That Met QC Criteria

February 1, 2023

First Posted (Actual)

February 2, 2023

Study Record Updates

Last Update Posted (Estimated)

February 6, 2024

Last Update Submitted That Met QC Criteria

February 5, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022515

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Apart from the participant's personal information.

IPD Sharing Time Frame

8 weeks

IPD Sharing Access Criteria

Apart from the participant's personal information

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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