Efficacy and Safety of Vitamin D Supplementation Combined With Alarm Therapy in Treating Nocturnal Enuresis

Xing Liu

Status: Enrolling

Conditions: Enuresis

Treatments: Drug: Vitamin D3; Behavioral: alarm therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06508333

2024424

Details and patient eligibility

About

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.

Full 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 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.

Enrollment: 260 estimated patients

Sex: All

Ages: 5 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

• Children aged 5-18 years diagnosed with PMNE-defined as intermittent urinary incontinence during sleep in a children who are never dry for more than 6 months and have no other lower urinary tract symptoms-according to the latest International Children's Continence Society guidelines, presenting at outpatient urology clinics.
• Serum vitamin D level below 30 ng/mL.
• Written informed consent obtained from each participant and their guardian.
• Adequate psychological and cognitive function, no communication barriers, and ability to accurately report symptoms and potential adverse reactions during treatment.

Exclusion Criteria

• Urological malformations or serious urological disease, such as hypospadias, cryptorchidism, posterior urethral valves, vesicoureteral reflux, neurogenic bladder, urinary tumors, urinary stones, or bladder/urethral injuries.
• Neurological disorders, including epilepsy, spinal cord injury or dysplasia, spinal embolism syndrome, multiple sclerosis, autism spectrum disorder, or attention-deficit/hyperactivity disorder.
• Endocrine diseases, such as diabetes mellitus or hyperthyroidism.
• Severe systemic disease, including significant cardiac disease, renal or hepatic insufficiency, pulmonary disease, bone deformities, gastrointestinal disorders, or inherited metabolic disorders.
• Conditions predisposing to sleep apnea, such as adenoid or tonsillar hypertrophy, deviated nasal septum, craniofacial abnormalities, or central sleep apnea.
• History of gastrointestinal or urological surgery.
• Use of anticonvulsant, antiepileptic, corticosteroid, or anti-tuberculosis medications.
• History of hypercalcemia, hyperphosphatemia, or renal rickets.
• Unexplained hematuria or urinary tract infection within the past year.
• Allergy to vitamin D formulations.
• Concurrent participation in other clinical studies.
• Unwillingness to participate or poor anticipated follow-up compliance.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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260 participants in 2 patient groups

Alarm therapy

Active Comparator group

Description:

These patients will receive alarm therapy for 8 weeks

Treatment:

Behavioral: alarm therapy

Alarm therapy combined with short-term high dose exogenous vitamin D supplementation

Experimental group

Description:

These patients will receive high-dose vitamin D supplementation (more than 2000IU daily) and alarm therapy for 8 weeks

Treatment:

Behavioral: alarm therapy

Drug: Vitamin D3