Efficacy and Safety of High-Dose Vitamin D Supplementation vs Solifenacin or Standard Urotherapy for Overactive Bladder Dry in Children: A Randomized Clinical Trial

作者全名："Chen, Hongsong; Zhang, Zhicheng; Wu, Shengde; Zhang, Deying; Zhong, Xiaoni; Liu, Xing; Wei, Guanghui"

作者地址："[Chen, Hongsong; Zhang, Zhicheng; Wu, Shengde; Zhang, Deying; Liu, Xing; Wei, Guanghui] Chongqing Med Univ, Dept Urol, Childrens Hosp, 136 Zhongshan Rd, Chongqing 400014, Peoples R China; [Chen, Hongsong; Zhang, Zhicheng; Wu, Shengde; Zhang, Deying; Liu, Xing; Wei, Guanghui] Minist Educ, Key Lab Child Dev & Disorders, Chongqing, Peoples R China; [Chen, Hongsong; Zhang, Zhicheng; Wu, Shengde; Zhang, Deying; Liu, Xing; Wei, Guanghui] Natl Clin Res Ctr Child Hlth & Disorders, Chongqing, Peoples R China; [Chen, Hongsong; Zhang, Zhicheng; Wu, Shengde; Zhang, Deying; Liu, Xing; Wei, Guanghui] China Int Sci & Technol, Cooperat Base Child Dev & Crit Disorders, Chongqing, Peoples R China; [Chen, Hongsong; Zhang, Zhicheng; Wu, Shengde; Zhang, Deying; Liu, Xing; Wei, Guanghui] Chongqing Med Univ, Childrens Hosp, Chongqing, Peoples R China; [Chen, Hongsong; Zhang, Zhicheng; Wu, Shengde; Zhang, Deying; Liu, Xing; Wei, Guanghui] Chongqing Key Lab Pediat, Chongqing, Peoples R China; [Chen, Hongsong; Zhang, Zhicheng; Wu, Shengde; Zhang, Deying; Liu, Xing; Wei, Guanghui] Chongqing Key Lab Children Urogenital Dev & Tissue, Chongqing, Peoples R China; [Chen, Hongsong; Zhang, Zhicheng; Wu, Shengde; Zhang, Deying; Zhong, Xiaoni; Liu, Xing; Wei, Guanghui] Chongqing Med Univ, Chongqing, Peoples R China; [Zhong, Xiaoni] Chongqing Med Univ, Sch Publ Hlth & Management, Chongqing, Peoples R China"

通信作者："Liu, X (通讯作者)，Chongqing Med Univ, Dept Urol, Childrens Hosp, 136 Zhongshan Rd, Chongqing 400014, Peoples R China."

来源：JOURNAL OF UROLOGY

ESI学科分类：CLINICAL MEDICINE

WOS号：WOS:001125221300002

JCR分区：Q1

影响因子：6.6

年份：2024

卷号：211

期号：1

开始页：26

结束页：36

文献类型：Article

关键词：overactive bladder; children; vitamin D; randomized controlled trial; safety

摘要："Purpose: We investigated the efficacy and safety of high-dose vitamin D supplementation (VDS) plus standard urotherapy (SU) in managing overactive bladder dry in children.Materials and Methods: A 3-arm, randomized clinical trial was performed at an academic center in China between January 2023 and June 2023. Eligible patients (n=303) were randomized to receive 8 weeks of high-dose VDS (vitamin D3 drops encapsulated as soft capsules, 2400 IU/d) plus SU (VDS + SU group; n=100), solifenacin (5-10 mg/d) plus SU (SOL + SU group; n=102), or SU alone (SU group; n=101). Reduction in voiding frequency was the primary outcome. Secondary outcomes encompassed improvement in urgency, nocturia, quality of life score, pediatric lower urinary tract symptom score, and participant satisfaction. Treatment-emergent adverse events were recorded within each group.Results: Participants had a median age of 82.0 months and their baseline mean vitamin D level was 22.64 ng/mL. The VDS + SU group showed greater improvements in voids/d than the SOL + SU group (median difference 3.0; 95% CI, 2.0 to 3.5; P < .001) and the SU group (median difference 4.0; 95% CI, 3.0 to 5.0; P < .001) after intervention. The VDS + SU group also showed the greatest improvement in quality of life and pediatric lower urinary tract symptom scores. Patient satisfaction was similar between the SOL + SU and SU groups. The VDS + SU group did not exhibit a heightened risk of treatment-emergent adverse events compared to the other groups.Conclusions: High-dose VDS plus SU was effective and well-tolerated in managing overactive bladder dry in children, suggesting its potential as a novel therapeutic option for this population."

基金机构："The National Natural Science Foundation of China; MPH (School of Public Health and Management, Chongqing Medical University)"

基金资助正文："We thank Junjun Dong, MD, Xingyue He, MD, Yi Wei, MD, and Chun Wei, MD (Children's Hospital of Chongqing Medical University), for serving as the medical monitors for this study. We thank Chong Wang, MD, Zihan Ye, MM, and Xiao Wang, MM (Children's Hospital of Chongqing Medical University), for serving as study coordinators. We thank Yanxi Wang, MM (Children's Hospital of Chongqing Medical University), for serving as the clinical data manager. We thank Bin Lin, MPH (School of Public Health and Management, Chongqing Medical University), and Zhenmin Liu, MD (Children's Hospital of Chongqing Medical University), for developing the statistical plan. All of these persons provided uncompensated assistance. We thank all of the participating families for participating in this clinical trial."