Ignite Creation Date:
2024-05-06 @ 7:59 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06201013
Status:
RECRUITING
Last Update Posted:
2024-01-11
First Post:
2023-09-26
Brief Title:
Efficacy and Safety of Vitamin D in the Treatment of OAB-wet in Children
Sponsor:
Xing Liu
Organization:
Childrens Hospital of Chongqing Medical University
Study Overview
Official Title:
Efficacy and Safety of Vitamin D in the Treatment of Wet Overactive Bladder in Children a Clinical Randomized Controlled Test
Status:
RECRUITING
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this clinical trial is to investigate whether standard behavioral therapy combined with high-dose vitamin D 2400iu daily is superior to standard behavioral therapy alone and standard behavioral therapy combined with solifenacin medication in improving frequency of incontinence and lower urinary tract symptom scores in children with wet OAB Dedicated to understanding the current best treatment for wet OAB and to informing future clinical decisions and improving patient prognosis The main questions it seeks to answer are
Question 1 To attempt to elucidate the relationship between vitamin D levels and their lower urinary tract symptoms
Question 2 To examine the etiologic role of vitamin D in wet OAB in children
Question 3 Compare the effectiveness and safety of interventions to elucidate the etiologic mechanisms and optimal intervention strategies for wet OAB in children
The researchers will compare 1 standard behavioral therapy with solifenacin 2 standard behavioral therapy with high-dose vitamin D 3 standard behavioral therapy alone to observe the clinical efficacy and safety of the three interventions for children with wet OAB
Question 1 To attempt to elucidate the relationship between vitamin D levels and their lower urinary tract symptoms
Question 2 To examine the etiologic role of vitamin D in wet OAB in children
Question 3 Compare the effectiveness and safety of interventions to elucidate the etiologic mechanisms and optimal intervention strategies for wet OAB in children
The researchers will compare 1 standard behavioral therapy with solifenacin 2 standard behavioral therapy with high-dose vitamin D 3 standard behavioral therapy alone to observe the clinical efficacy and safety of the three interventions for children with wet OAB
Detailed Description:
Study Objective Primary objective to investigate whether standard behavioral therapy combined with high-dose vitamin D 2400iu per day is superior to standard behavioral therapy alone and standard behavioral therapy combined with solifenacin medication in improving frequency of urinary incontinence and lower urinary tract symptom scores in children with wet OAB
Secondary objectives
1 To investigate whether this standard behavioral therapy combined with oral solifenacin and vitamin D supplementation regimen is superior to the remaining two groups in the following secondary efficacy outcomes
Number of urinations per day
number of nocturia
Quality of life
Serum vitamin D levels
Overall patient satisfaction with treatment
2 To examine whether any effect of vitamin D supplementation on the above outcomes is modified by baseline vitamin D levels and baseline lower urinary tract symptom severity secondary outcome efficacy
3 Explore whether the treatment regimen of standard behavioral therapy combined with oral solifenacin and vitamin D is safe and well tolerated secondary outcome safety
Study Steps
1 Design of Randomization Methods After completion of a comprehensive baseline assessment eligible participants are randomized 111 into three distinct intervention groups Statisticians independent of this clinical monitoring will generate a randomization table from the PROC PLAN process of the SAS program based on predetermined seed and block numbers The generated randomization codes will be recorded sequentially in sealed envelopes entrusted to the custody of the residents not involved in the trial
2 Procedure for inclusion of study subjects participants will be selected among patients with confirmed wet OAB and serum vitamin D levels below 35 ngml in the urology department of our hospital We will exclude patients with other organic diseases and poor compliance The guardians of the children will obtain informed consent and sign a paper consent form before starting the intervention
4Clinical data collection information on the demographic characteristics of the child at the initial visit medical history family history history of maternal vitamin D supplementation during pregnancy history of vitamin D supplementation in the child laboratory findings serum vitamin D routine urinalysis abdominal imaging findings and a diary of voiding will be kept by the participant for 7 days to establish a baseline
Secondary objectives
1 To investigate whether this standard behavioral therapy combined with oral solifenacin and vitamin D supplementation regimen is superior to the remaining two groups in the following secondary efficacy outcomes
Number of urinations per day
number of nocturia
Quality of life
Serum vitamin D levels
Overall patient satisfaction with treatment
2 To examine whether any effect of vitamin D supplementation on the above outcomes is modified by baseline vitamin D levels and baseline lower urinary tract symptom severity secondary outcome efficacy
3 Explore whether the treatment regimen of standard behavioral therapy combined with oral solifenacin and vitamin D is safe and well tolerated secondary outcome safety
Study Steps
1 Design of Randomization Methods After completion of a comprehensive baseline assessment eligible participants are randomized 111 into three distinct intervention groups Statisticians independent of this clinical monitoring will generate a randomization table from the PROC PLAN process of the SAS program based on predetermined seed and block numbers The generated randomization codes will be recorded sequentially in sealed envelopes entrusted to the custody of the residents not involved in the trial
2 Procedure for inclusion of study subjects participants will be selected among patients with confirmed wet OAB and serum vitamin D levels below 35 ngml in the urology department of our hospital We will exclude patients with other organic diseases and poor compliance The guardians of the children will obtain informed consent and sign a paper consent form before starting the intervention
4Clinical data collection information on the demographic characteristics of the child at the initial visit medical history family history history of maternal vitamin D supplementation during pregnancy history of vitamin D supplementation in the child laboratory findings serum vitamin D routine urinalysis abdominal imaging findings and a diary of voiding will be kept by the participant for 7 days to establish a baseline
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None