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

Primary Purpose

Overactive Bladder

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Solifenacin Succinate 5 MG Oral Tablet [Vesicare]
Vitamin D3
Standard urotherapy
Sponsored by
Xing Liu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overactive Bladder

Eligibility Criteria

5 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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). Children with a serum vitamin D level of less than 35 ng/ml as indicated by the laboratory result. Written informed consent was obtained from participants and their parents. - Exclusion Criteria: 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.). 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.) . Those with acomorbidity of severe heart disease, abnormal liver or kidney function, lung disease, skeletal deformities, severe gastrointestinal disease, or inherited metabolic disorders. Those with a history of gastrointestinal surgery and urinary tract surgery. Those with chronic constipation. Those taking anticonvulsant and antiepileptic drugs, hormones, anti-tuberculosis drugs. Those have a previous history of hypercalcemia, hyperphosphatemia with renal rickets. Those have a history of haematuria and urinary tract infection within the last 1 year. Those have a history of allergy or allergic disease to vitamin D preparations. Those Participate in other clinical studies at the time of consultation or during the follow-up of other clinical studies. Any condition that could cause urinary symptoms or interfere with assessment of efficacy parameters. Those unwilling to participate in this study. -

Sites / Locations

  • Children's Hospital of Chongqing Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

High dose vitamin D supplementation (combined with standard urotherapy)

Solifenacin succinate group (combined with standard urotherapy)

standard urotherapy group

Arm Description

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

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

These patients will receive behavioral therapy alone for 8 weeks.

Outcomes

Primary Outcome Measures

Change in voiding frequency
Change in voiding frequency as documented in the bladder diaries (voids/d) from baseline to the followup

Secondary Outcome Measures

Change in mean urgency score
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
Change in max urgency score
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
Change in pediatric lower urinary tract symptom score
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.
Change in quality of life score
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.
Change in mean nocturia frequency, episodes/night
Change in mean nocturia frequency from baseline to the followup
Change in vitamin D level
Change in vitamin D level from baseline to the followup
Global perception of improvement
Global perception of improvement (much better; better; about the same; worse)
Wish to receive another form of treatment?
Wish to receive another form of treatment? (YES; No)

Full Information

First Posted
January 18, 2023
Last Updated
May 12, 2023
Sponsor
Xing Liu
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1. Study Identification

Unique Protocol Identification Number
NCT05709990
Brief Title
Efficacy and Safety of High Dose Vitamin D Supplementation for Overactive Bladder Dry in Children
Official Title
Efficacy and Safety of High Dose Vitamin D Supplementation for Overactive Bladder Dry in Children: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 15, 2023 (Actual)
Primary Completion Date
May 30, 2023 (Anticipated)
Study Completion Date
August 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Xing Liu

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The 3 groups will be treated at the same time
Masking
InvestigatorOutcomes Assessor
Masking Description
outcome evaluators, and statisticians were blinded.
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
High dose vitamin D supplementation (combined with standard urotherapy)
Arm Type
Experimental
Arm Description
These patients will receive high dose vitamin D supplementation (more than 2000IU daily) and behavioral therapy for 8 weeks
Arm Title
Solifenacin succinate group (combined with standard urotherapy)
Arm Type
Active Comparator
Arm Description
These patients will receive solifenacin (5-10 mg daily) and behavioral therapy for 8 weeks
Arm Title
standard urotherapy group
Arm Type
Active Comparator
Arm Description
These patients will receive behavioral therapy alone for 8 weeks.
Intervention Type
Drug
Intervention Name(s)
Solifenacin Succinate 5 MG Oral Tablet [Vesicare]
Other Intervention Name(s)
standard urotherapy
Intervention Description
These patients will receive solifenacin 5-10 MG daily (combined with standard urotherapy) for 8 weeks.
Intervention Type
Drug
Intervention Name(s)
Vitamin D3
Other Intervention Name(s)
standard urotherapy
Intervention Description
These patients will receive high dose vitamin D supplementation (more than 2000IU daily) (combined with standard urotherapy) for 8 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Standard urotherapy
Intervention Description
These patients will receive standard urotherapyfor 8 weeks.
Primary Outcome Measure Information:
Title
Change in voiding frequency
Description
Change in voiding frequency as documented in the bladder diaries (voids/d) from baseline to the followup
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Change in mean urgency score
Description
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
Time Frame
8 weeks
Title
Change in max urgency score
Description
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
Time Frame
8 weeks
Title
Change in pediatric lower urinary tract symptom score
Description
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.
Time Frame
8 weeks
Title
Change in quality of life score
Description
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.
Time Frame
8 weeks
Title
Change in mean nocturia frequency, episodes/night
Description
Change in mean nocturia frequency from baseline to the followup
Time Frame
8 weeks
Title
Change in vitamin D level
Description
Change in vitamin D level from baseline to the followup
Time Frame
8 weeks
Title
Global perception of improvement
Description
Global perception of improvement (much better; better; about the same; worse)
Time Frame
8 weeks
Title
Wish to receive another form of treatment?
Description
Wish to receive another form of treatment? (YES; No)
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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). Children with a serum vitamin D level of less than 35 ng/ml as indicated by the laboratory result. Written informed consent was obtained from participants and their parents. - Exclusion Criteria: 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.). 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.) . Those with acomorbidity of severe heart disease, abnormal liver or kidney function, lung disease, skeletal deformities, severe gastrointestinal disease, or inherited metabolic disorders. Those with a history of gastrointestinal surgery and urinary tract surgery. Those with chronic constipation. Those taking anticonvulsant and antiepileptic drugs, hormones, anti-tuberculosis drugs. Those have a previous history of hypercalcemia, hyperphosphatemia with renal rickets. Those have a history of haematuria and urinary tract infection within the last 1 year. Those have a history of allergy or allergic disease to vitamin D preparations. Those Participate in other clinical studies at the time of consultation or during the follow-up of other clinical studies. Any condition that could cause urinary symptoms or interfere with assessment of efficacy parameters. Those unwilling to participate in this study. -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xing Liu, Doctor
Phone
86-23-63612114
Email
dr.liux0217@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xing Liu, Doctor
Organizational Affiliation
Children's Hospital of Chongqing Medical University
Official's Role
Study Director
Facility Information:
Facility Name
Children's Hospital of Chongqing Medical University
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li Qiu, Doctor
Phone
86-23-63612114
Email
dr.liux0217@163.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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
Citations:
PubMed Identifier
24508614
Citation
Austin PF, Bauer SB, Bower W, Chase J, Franco I, Hoebeke P, Rittig S, Vande Walle J, von Gontard A, Wright A, Yang SS, Neveus T. The standardization of terminology of lower urinary tract function in children and adolescents: update report from the Standardization Committee of the International Children's Continence Society. J Urol. 2014 Jun;191(6):1863-1865.e13. doi: 10.1016/j.juro.2014.01.110. Epub 2014 Feb 4.
Results Reference
background
PubMed Identifier
27530266
Citation
Franco I. Overactive bladder in children. Nat Rev Urol. 2016 Sep;13(9):520-32. doi: 10.1038/nrurol.2016.152. Epub 2016 Aug 17.
Results Reference
background
PubMed Identifier
16005564
Citation
Abrams P, Swift S. Solifenacin is effective for the treatment of OAB dry patients: a pooled analysis. Eur Urol. 2005 Sep;48(3):483-7. doi: 10.1016/j.eururo.2005.06.007.
Results Reference
background
PubMed Identifier
33207134
Citation
Yuan P, Wang T, Li H, Lan R, Li M, Liu J. Systematic Review and Meta-Analysis of the Association between Vitamin D Status and Lower Urinary Tract Symptoms. J Urol. 2021 Jun;205(6):1584-1594. doi: 10.1097/JU.0000000000001441. Epub 2020 Nov 18.
Results Reference
background
PubMed Identifier
36067369
Citation
Markland AD, Vaughan CP, Huang AJ, Kim E, Bubes VY, Tangpricha V, Buring JR, Lee IM, Cook NR, Manson JE, Grodstein F. Effect of Vitamin D Supplementation on Overactive Bladder and Urinary Incontinence Symptoms in Older Men: Ancillary Findings From a Randomized Trial. J Urol. 2023 Jan;209(1):243-252. doi: 10.1097/JU.0000000000002942. Epub 2022 Sep 6.
Results Reference
background
PubMed Identifier
35420658
Citation
Brustad N, Yousef S, Stokholm J, Bonnelykke K, Bisgaard H, Chawes BL. Safety of High-Dose Vitamin D Supplementation Among Children Aged 0 to 6 Years: A Systematic Review and Meta-analysis. JAMA Netw Open. 2022 Apr 1;5(4):e227410. doi: 10.1001/jamanetworkopen.2022.7410.
Results Reference
background

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

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