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

NCT ID: NCT06508333

Last Updated: 2025-09-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 260 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-01
• Study Completion Date: 2025-10-01

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 primary monosymptomatic 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 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.

Conditions

Enuresis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Alarm therapy

These patients will receive alarm therapy for 8 weeks

Group Type: ACTIVE_COMPARATOR

alarm therapy

Intervention Type: BEHAVIORAL

These patients will receive alarm therapy for 8 weeks.

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

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

Group Type: EXPERIMENTAL

alarm therapy

Intervention Type: BEHAVIORAL

These patients will receive alarm therapy for 8 weeks.

Vitamin D3

Intervention Type: DRUG

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

Interventions

alarm therapy

These patients will receive alarm therapy for 8 weeks.

Intervention Type: BEHAVIORAL

Vitamin D3

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

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xing Liu

OTHER

Sponsor Role: lead

Responsible Party

Xing Liu

Professor, Doctor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Xing Liu, Doctor

Role: STUDY_DIRECTOR

Children's Hospital of Chongqing Medical University

Locations

Children's Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xing Liu, Doctor

Role: CONTACT

dr.liux0217@gmail.com

86-23-63612114

Facility Contacts

Ziyu Hua, Doctor

Role: primary

dr.liux0217@163.com

86-23-63612114

References

Wen JG, Wang QW, Chen Y, Wen JJ, Liu K. An epidemiological study of primary nocturnal enuresis in Chinese children and adolescents. Eur Urol. 2006 Jun;49(6):1107-13. doi: 10.1016/j.eururo.2005.11.011. Epub 2005 Dec 27.

Reference Type: BACKGROUND

PMID: 16406243 (View on PubMed)

Robson WL. Clinical practice. Evaluation and management of enuresis. N Engl J Med. 2009 Apr 2;360(14):1429-36. doi: 10.1056/NEJMcp0808009. No abstract available.

Reference Type: BACKGROUND

PMID: 19339722 (View on PubMed)

Hara T, Ohtomo Y, Endo A, Niijima S, Yasui M, Shimizu T. Evaluation of Urinary Aquaporin 2 and Plasma Copeptin as Biomarkers of Effectiveness of Desmopressin Acetate for the Treatment of Monosymptomatic Nocturnal Enuresis. J Urol. 2017 Oct;198(4):921-927. doi: 10.1016/j.juro.2017.04.088. Epub 2017 Apr 28.

Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 33453761 (View on PubMed)

Tsuji S, Suruda C, Kimata T, Kino J, Yamanouchi S, Kaneko K. The Effect of Family Assistance to Wake Children with Monosymptomatic Enuresis in Alarm Therapy: A Pilot Study. J Urol. 2018 Apr;199(4):1056-1060. doi: 10.1016/j.juro.2017.11.072. Epub 2017 Nov 23.

Reference Type: BACKGROUND

PMID: 29175540 (View on PubMed)

Yeung CK, Sihoe JD, Sit FK, Diao M, Yew SY. Urodynamic findings in adults with primary nocturnal enuresis. J Urol. 2004 Jun;171(6 Pt 2):2595-8. doi: 10.1097/01.ju.0000112790.72612.0a.

Reference Type: BACKGROUND

PMID: 15118427 (View on PubMed)

Other Identifiers

2024424

Identifier Type: -

Identifier Source: org_study_id