Clinical trial NCT06508333: Efficacy and Safety of Vitamin D Supplementation Combined with Alarm Therapy in Treating Nocturnal Enuresis
Official title: Efficacy and Safety of Vitamin D Supplementation Combined with Alarm Therapy in Treating Nocturnal Enuresis: a Prospective, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Enuresis
Lead sponsor: Children's Hospital of Chongqing Medical University
Sponsor class: OTHER
First posted: 2024-07-18
Enrollment: 160
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Children older than 5 years diagnosed with enuresis at outpatient urology clinics, following the latest recommendations from the International Children's Continence Society.
2. Children with serum vitamin D levels below 35 ng/ml, as indicated by laboratory results.
3. Written informed consent obtained from both participants and their parents.

Exclusion Criteria:

1. 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.
2. Patients with comorbid neurological disorders, including epilepsy, spinal cord injury, spinal cord dysplasia, spinal cord embolism syndrome, multiple sclerosis, and autism spectrum disorder.
3. Patients with comorbid severe heart disease, abnormal liver or kidney function, lung disease, skeletal deformities, severe gastrointestinal disease, or inherited metabolic disorders.
4. Patients with a history of gastrointestinal surgery or urinary tract surgery.
5. Patients taking anticonvulsant, antiepileptic, hormone, or anti-tuberculosis medications.
6. Patients with a history of hypercalcemia or hyperphosphatemia with renal rickets.
7. Patients with a history of hematuria or urinary tract infection within the last year.
8. Patients with a history of allergy or allergic reactions to vitamin D preparations.
9. Patients participating in other clinical studies at the time of consultation or during follow-up.
10. Any condition that could cause urinary symptoms or interfere with the assessment of efficacy parameters.
11. Patients unwilling to participate in the study.

Primary outcomes:
measure: Change in enuresis frequency
timeFrame: 8 week
Secondary outcomes:
measure: Change in quality of life score
timeFrame: 8 week
measure: Change in vitamin D level
timeFrame: 8 week
measure: Global perception of improvement
timeFrame: 8 week
measure: Wish to receive another form of treatment?
timeFrame: 8 week
measure: Change in mean nocturia frequency, episodes/night
timeFrame: 8 week
measure: Treatment adherence
timeFrame: 8 week
measure: Incidence of side effects
timeFrame: 8 week
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Children's Hospital of Chongqing Medical University
state: Chongqing
Study officials:
affiliation: Children's Hospital of Chongqing Medical University
name: Xing Liu, Doctor
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.