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

NCT06508333 | Completed DMC

• 1 other identifier: 2024424
• Study Type: interventional
• Target: 262
• Locations: 1 country
• Sites: 1

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.

Conditions

Enuresis

Outcome Measures

Primary Outcomes (2)

• Response after interventions

  Response rate: defined as a ≥50% reduction in the number of wet nights per week

  8 weeks

• Complete response after interventions

  The rate of complete response was defined as a 100% reduction in wet nights per week.

  8 weeks

Secondary Outcomes (8)

• Change in enuresis frequency

  8 weeks

• Change in quality of life score

  8 week

• Change in vitamin D level

  8 week

• Change in serum levels of calcium

  8 weeks

• Global perception of improvement

  8 week

Study Arms (2)

Alarm therapy

ACTIVE COMPARATOR

These patients will receive alarm therapy for 8 weeks

Behavioral: alarm therapy

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

EXPERIMENTAL

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

Behavioral: alarm therapy; Drug: Vitamin D3

Interventions

Vitamin D3 DRUG

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

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

alarm therapy BEHAVIORAL

These patients will receive alarm therapy for 8 weeks.

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

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xing Liu: lead

Study Sites (1)

Children's Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400000, China

Location

Related Publications (6)

• 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.

  PMID: 16406243 BACKGROUND

• 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.

  PMID: 19339722 BACKGROUND

• 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.

  PMID: 28457803 BACKGROUND

• Jorgensen CS, Horsdal HT, Rajagopal VM, Grove J, Als TD, Kamperis K, Nyegaard M, Walters GB, Eethvarethsson VO, Stefansson H, Nordentoft M, Hougaard DM, Werge T, Mors O, Mortensen PB, Agerbo E, Rittig S, Stefansson K, Borglum AD, Demontis D, Christensen JH. Identification of genetic loci associated with nocturnal enuresis: a genome-wide association study. Lancet Child Adolesc Health. 2021 Mar;5(3):201-209. doi: 10.1016/S2352-4642(20)30350-3. Epub 2021 Jan 15.

  PMID: 33453761 BACKGROUND

• 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.

  PMID: 29175540 BACKGROUND

• 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.

  PMID: 15118427 BACKGROUND

MeSH Terms

Conditions

Enuresis

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Behavioral Symptoms; Behavior; Elimination Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Xing Liu, Doctor

  Children's Hospital of Chongqing Medical University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, Doctor

Study Record Dates

• First Submitted: July 14, 2024
• First Posted: July 18, 2024
• Study Start: December 1, 2024
• Primary Completion: March 31, 2025
• Study Completion: May 31, 2025
• Last Updated: February 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 8 weeks
• Access Criteria: Apart from the participant's personal information

Locations

CN (1)