Efficacy and Safety of Vitamin D Supplementation Combined with Alarm Therapy in Treating Nocturnal Enuresis
- Conditions
- Enuresis
- Interventions
- Behavioral: alarm therapy
- Registration Number
- NCT06508333
- Lead Sponsor
- Xing Liu
- Brief Summary
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 nocturnal enuresis compared to alarm therapy alone.
- Detailed Description
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 NE. 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 NE.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 160
- Children older than 5 years diagnosed with enuresis at outpatient urology clinics, following the latest recommendations from the International Children's Continence Society.
- Children with serum vitamin D levels below 35 ng/ml, as indicated by laboratory results.
- Written informed consent obtained from both participants and their parents.
- Patients with comorbidities of other urological abnormalities or serious diseases, such as hypospadias, cryptorchidism, posterior urethral valves, vesicoureteral reflux, neurogenic bladder, urological tumors, urinary stones, and bladder and urethral injuries.
- Patients with comorbid neurological disorders, including epilepsy, spinal cord injury, spinal cord dysplasia, spinal cord embolism syndrome, multiple sclerosis, and autism spectrum disorder.
- Patients with comorbid severe heart disease, abnormal liver or kidney function, lung disease, skeletal deformities, severe gastrointestinal disease, or inherited metabolic disorders.
- Patients with a history of gastrointestinal surgery or urinary tract surgery.
- Patients taking anticonvulsant, antiepileptic, hormone, or anti-tuberculosis medications.
- Patients with a history of hypercalcemia or hyperphosphatemia with renal rickets.
- Patients with a history of hematuria or urinary tract infection within the last year.
- Patients with a history of allergy or allergic reactions to vitamin D preparations.
- Patients participating in other clinical studies at the time of consultation or during follow-up.
- Any condition that could cause urinary symptoms or interfere with the assessment of efficacy parameters.
- Patients unwilling to participate in the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Alarm therapy alarm therapy These patients will receive alarm therapy for 8 weeks Alarm therapy combined with short-term high dose exogenous vitamin D supplementation alarm therapy These patients will receive high-dose vitamin D supplementation (more than 2000IU daily) and alarm therapy for 8 weeks Alarm therapy combined with short-term high dose exogenous vitamin D supplementation Vitamin D3 These patients will receive high-dose vitamin D supplementation (more than 2000IU daily) and alarm therapy for 8 weeks
- Primary Outcome Measures
Name Time Method Change in enuresis frequency 8 week Change in enuresis frequency from baseline to follow-up
- Secondary Outcome Measures
Name Time Method Wish to receive another form of treatment? 8 week Wish to receive another form of treatment? (YES; No)
Change in mean nocturia frequency, episodes/night 8 week Change in mean nocturia frequency from baseline to follow-up
Incidence of side effects 8 week Type and frequency of side effects during treatment
Treatment adherence 8 week The extent to which a patient adheres to their medication schedule, including both timing and dosage, or follows the prescribed treatment regimen
Change in quality of life score 8 week 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.
Change in vitamin D level 8 week Change in vitamin D level from baseline to follow-up
Global perception of improvement 8 week Global perception of improvement (much better; better; about the same; worse)
Trial Locations
- Locations (1)
Children's Hospital of Chongqing Medical University
🇨🇳Chongqing, Chongqing, China