This prospective, randomized, two-arm, parallel-design controlled clinical trial aims to determine whether high-dose vitamin D supplementation combined with alarm therapy improves outcomes in children with primary monosymptomatic nocturnal enuresis compared to alarm therapy alone.
Nocturnal enuresis (NE) is characterized by recurrent involuntary urination during sleep in children aged 5 years and older, persisting for over three months with at least two episodes per week. This condition, resulting from the child's inability to awaken from sleep, exhibits a prevalence rate ranging from 4.8% to 15.2%, which notably declines with age. Moreover, NE significantly impacts the psychological well-being and overall quality of life of affected individuals. The primary treatments for NE include desmopressin acetate (DDAVP) and behavioral interventions (BI). While these modalities offer therapeutic benefits, their implementation is often prolonged and fraught with challenges, including adverse drug reactions and a high rate of symptom recurrence after treatment discontinuation. These factors complicate adherence for both patients and their families. Patients with NE are more likely to suffer from vitamin D deficiency. This study aims to determine the effect of vitamin D supplementation as an adjunctive therapy to alarm therapy in the treatment of primary monosymptomatic nocturnal enuresis(PMNE). Eligible patients aged 5-18 years with a diagnosis of NE will be randomly assigned to receive either high-dose vitamin D supplementation combined with alarm therapy or alarm therapy alone. Serum levels of 25(OH)D will be measured at baseline. Symptom severity will be assessed at baseline and follow-up, along with other sociodemographic data. This study will provide more information on the role of vitamin D supplementation in managing PMNE.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
260
These patients will receive alarm therapy for 8 weeks.
These patients will receive high-dose vitamin D supplementation (more than 2000IU daily) (combined with alarm therapy) for 8 weeks.
Children's Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
RECRUITINGChange in enuresis frequency
Change in enuresis frequency from baseline to follow-up
Time frame: 8 week
Response after interventions
Response rate: defined as a ≥50% reduction in the number of wet nights per week
Time frame: 8 weeks
Complete response after interventions
The rate of complete response was defined as a 100% reduction in wet nights per week.
Time frame: 8 weeks
Change in quality of life score
The quality of life was assessed using a scale ranging from 0 to 3, where a score of 0 indicated no impact on family, social, or academic life, a score of 1 indicated occasional impact, a score of 2 indicated significant impact, and a score of 3 indicated severe impact on family, social, or academic life.
Time frame: 8 week
Change in vitamin D level
Change in vitamin D level from baseline to follow-up
Time frame: 8 week
Change in serum levels of calcium
Change in serum levels of calcium from baseline to follow-up
Time frame: 8 weeks
Global perception of improvement
Global perception of improvement (much better; better; about the same; worse)
Time frame: 8 week
Wish to receive another form of treatment?
Wish to receive another form of treatment? (YES; No)
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Time frame: 8 week
Treatment adherence
The extent to which a patient adheres to their medication schedule, including both timing and dosage, or follows the prescribed treatment regimen
Time frame: 8 week
Incidence of side effects
Type and frequency of side effects during treatment
Time frame: 8 week