Efficacy and Safety of High Dose Vitamin D Supplementation for Overactive Bladder Dry in Children: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 303
- 试验地点
- 1
- 主要终点
- Change in voiding frequency
研究概览
简要总结
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.
详细描述
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.
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 (Investigator, Outcomes Assessor)
盲法说明
outcome evaluators, and statisticians were blinded.
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 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. -
排除标准
- •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. -
研究组 & 干预措施
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
干预措施: Vitamin D3 (Drug)
Solifenacin succinate group (combined with standard urotherapy)
These patients will receive solifenacin (5-10 mg daily) and behavioral therapy for 8 weeks
干预措施: Solifenacin Succinate 5 MG Oral Tablet [Vesicare] (Drug)
standard urotherapy group
These patients will receive behavioral therapy alone for 8 weeks.
干预措施: Standard urotherapy (Behavioral)
结局指标
主要结局
Change in voiding frequency
时间窗: 8 weeks
Change in voiding frequency as documented in the bladder diaries (voids/d) from baseline to the followup
次要结局
- Change in pediatric lower urinary tract symptom score(8 weeks)
- Global perception of improvement(8 weeks)
- Change in mean urgency score(8 weeks)
- Change in max urgency score(8 weeks)
- Change in quality of life score(8 weeks)
- Change in mean nocturia frequency, episodes/night(8 weeks)
- Change in vitamin D level(8 weeks)
- Wish to receive another form of treatment?(8 weeks)
研究者
Xing Liu
Director of Urology, Children's Hospital of Chongqing Medical University
Children's Hospital of Chongqing Medical University