Role of Vitamin D Supplementation Versus Desmopressin Versus Their Combination in the Treatment of Primary Monosymptomatic Nocturnal Enuresis in Children With Vitamin D Deficiency: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Change in number of wet nights per week at 3 months
研究概览
简要总结
This randomized clinical trial evaluated three treatment approaches for children aged 6 to 12 years who had primary monosymptomatic nocturnal enuresis (night-time bedwetting) and confirmed vitamin D deficiency. Bedwetting is common in school-aged children and can affect self-esteem, social interactions, and school performance. Although desmopressin is widely used, some children do not respond adequately. Previous studies suggested that low vitamin D levels might contribute to bedwetting, raising the possibility that vitamin D supplementation could help.
In this study, eligible children were randomly assigned to one of three groups:
- vitamin D supplementation alone,
- desmopressin alone, or
- a combination of vitamin D and desmopressin.
All participants were followed for up to six months. The primary aim was to compare the improvement in the number of wet nights per week among the three groups. Secondary assessments included treatment tolerability, changes in vitamin D levels, changes in serum sodium, and any treatment-related side effects.
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
- None
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children and adolescents aged 6 to 12 years
- •Primary monosymptomatic nocturnal enuresis
- •At least 2 episodes of night-time bedwetting per week for ≥3 consecutive months
- •Serum 25-hydroxyvitamin D level <20 ng/mL
- •Normal kidney function
- •Normal serum sodium level
- •Absence of daytime lower urinary tract symptoms (urgency, frequency, dysuria)
- •Informed consent from parent or guardian and assent from the child when appropriate
排除标准
- •Non-monosymptomatic nocturnal enuresis (daytime storage or voiding symptoms)
- •Congenital urinary tract anomalies (e.g., meatal stenosis, hypospadias, epispadias)
- •Urinary tract infection until culture becomes negative
- •Neurological abnormalities, including suspected neurogenic bladder
- •Endocrine diseases such as diabetes mellitus or hyperthyroidism
- •Congestive heart failure or significant cardiac disease
- •Prior or current use of vitamin D supplementation
- •Serum sodium below normal range
- •Chronic systemic illness
- •Any condition judged by investigators to interfere with study participation
研究组 & 干预措施
Vitamin D Monotherapy
Participants receive vitamin D supplementation at a dose of 2000 IU orally once daily for 6-12 weeks, followed by a maintenance dose of 600 IU orally once daily for the remainder of the 6-month treatment period.
干预措施: Vitamin D (Drug)
Desmopressin Monotherapy
Participants receive desmopressin 0.2 mg orally once daily at bedtime for the full 6-month treatment period. Dose adjustments follow standard pediatric nocturnal enuresis guidance if needed.
干预措施: Desmopressin (Drug)
Combination Therapy (Vitamin D + Desmopressin)
Participants receive vitamin D supplementation (2000 IU orally once daily for 6-12 weeks, then 600 IU daily) combined with desmopressin 0.2 mg orally once daily at bedtime for a total of 6 months.
干预措施: Desmopressin (Drug)
Combination Therapy (Vitamin D + Desmopressin)
Participants receive vitamin D supplementation (2000 IU orally once daily for 6-12 weeks, then 600 IU daily) combined with desmopressin 0.2 mg orally once daily at bedtime for a total of 6 months.
干预措施: Vitamin D (Drug)
结局指标
主要结局
Change in number of wet nights per week at 3 months
时间窗: Baseline and 3 months after initiation of therapy
Mean change in the number of nocturnal enuresis (bedwetting) episodes per week from baseline to 3 months after starting treatment, comparing the three groups (vitamin D alone, desmopressin alone, and combination therapy).
次要结局
- Change in number of wet nights per week at 6 months(Baseline and 6 months after initiation of therapy)
- Proportion of patients with complete response at 3 and 6 months(3 months and 6 months after initiation of therapy)
- Proportion of patients with partial response at 3 and 6 months(3 months and 6 months after initiation of therapy)
- Change in serum sodium level(Baseline, 1 week, 1 month, 3 months, and 6 months after initiation of desmopressin therapy)
- Change in serum 25-hydroxyvitamin D level(Baseline, 1 month, 3 months, and 6 months after initiation of therapy)
- Incidence of hyponatremia(Baseline to 6 months after initiation of therapy)
- Incidence of headache(Baseline to 6 months)
- Incidence of gastrointestinal symptoms(Baseline to 6 months)
- Incidence of polyuria(Baseline to 6 months)
研究者
Ibrahim Magdy Ibrahim Mohammed
Resident of Urology
Ain Shams University