Efficacy and Mechanism of High-Dose Vitamin D Supplementation in Pediatric OAB-Dry: A Randomized Clinical Trial Integrating Urinary Myelin Basic Protein as a Theranostic Biomarker
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Change in daily urination frequency
研究概览
简要总结
The aim of this study is to give children with dry OAB: (1) Standard behavioral therapy combined with classical anticholinergic drugs (Solinaxine), or (2) standard behavioral therapy combined with short-term high-dose exogenous vitamin D supplementation are used to compare the outcomes of lower urinary tract symptoms in children with dry OAB during follow-up. To provide more robust supporting evidence for the broader promotion of short-term high-dose exogenous vitamin D supplements in combination with standard behavioral therapy as an effective treatment for dry OAB treatment in children.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 5 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children older than 5 years who were admitted to the Department of Urology, Children's Hospital Affiliated to Chongqing Medical University and diagnosed with dry OAB.
- •The results of our laboratory indicated that the serum vitamin D level was lower than 35ng/mL.
- •The child (guardian) has been informed of the nature of the study, understands the provisions in the protocol, is able to guarantee compliance, and signs the informed consent.
排除标准
- •Patients with other urinary system malformations or serious diseases (such as hypospadias, cryptorchidism, posterior urethral valvular disease, vesicoureteral reflux, neurogenic bladder, urinary system tumors, urinary calculi, bladder and urethral injuries, etc.);
- •complicated with neurological diseases (such as epilepsy, spinal cord injury, spinal cord dysplasia, tethered cord syndrome, multiple sclerosis, autism spectrum disorder, etc.);
- •Patients with severe heart disease, abnormal liver and kidney function, lung disease, bone malformation, severe digestive tract disease, and genetic metabolic disease;
- •History of gastrointestinal surgery and urinary system surgery;
- •Dry stool, long-term constipation;
- •are taking anticonvulsant and antiepileptic drugs, hormones, antituberculosis drugs;
- •Previous history of hypercalcemia, hyperphosphatemia with renal rickets;
- •History of unexplained hematuria and urinary tract infection in the past 1 year;
- •Have a history of allergy or allergic reaction to vitamin D preparations;
- •Participating in another clinical study at the time of visit or during the follow-up of another clinical study;
- •Those who did not want to participate in the study or had poor follow-up compliance
研究组 & 干预措施
Standard Behavioral Therapy Combined with Solifenacin Drug Treatment
Solinasine succinate 5mg once daily with a maximum dose of 10mg/day. Standard Behavioral Therapy
干预措施: Solifenacin (Drug)
Standard Behavioral Therapy Combined with Solifenacin Drug Treatment
Solinasine succinate 5mg once daily with a maximum dose of 10mg/day. Standard Behavioral Therapy
干预措施: Standard behavioral therapy (Behavioral)
Standard behavioral therapy combined with short-term high dose exogenous vitamin D supplementation
Oral vitamin D drops, 2400iu/d, continued for 6 weeks after follow-up. Standard Behavioral Therapy
干预措施: vitamin D (Dietary Supplement)
Standard behavioral therapy combined with short-term high dose exogenous vitamin D supplementation
Oral vitamin D drops, 2400iu/d, continued for 6 weeks after follow-up. Standard Behavioral Therapy
干预措施: Standard behavioral therapy (Behavioral)
结局指标
主要结局
Change in daily urination frequency
时间窗: week 1, week6，week 12
To explore whether standard behavioral therapy combined with short-term high dose vitamin D (2400IU daily) is superior to standard behavioral therapy combined with anticholinergic drugs (Solinaxine) in improving the daily frequency of urination in children with dry OAB.
次要结局
- Change in the mean urgency score(week 1, week6，week 12)
- Change quality of life score(week 1, week6，week 12)
研究者
Xing Liu
Professor, Doctor
Children's Hospital of Chongqing Medical University