Vitamin D Versus Desmopressin Versus Combination Therapy in Children With Primary Monosymptomatic Nocturnal Enuresis and Vitamin D Deficiency

NCT ID: NCT07292753

Last Updated: 2025-12-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-15
• Study Completion Date: 2025-10-10

Brief Summary

This randomized clinical trial evaluated three treatment approaches for children aged 6 to 12 years who had primary monosymptomatic nocturnal enuresis (night-time bedwetting) and confirmed vitamin D deficiency. Bedwetting is common in school-aged children and can affect self-esteem, social interactions, and school performance. Although desmopressin is widely used, some children do not respond adequately. Previous studies suggested that low vitamin D levels might contribute to bedwetting, raising the possibility that vitamin D supplementation could help.

In this study, eligible children were randomly assigned to one of three groups:

1. vitamin D supplementation alone,

2. desmopressin alone, or

3. a combination of vitamin D and desmopressin.

All participants were followed for up to six months. The primary aim was to compare the improvement in the number of wet nights per week among the three groups. Secondary assessments included treatment tolerability, changes in vitamin D levels, changes in serum sodium, and any treatment-related side effects.

Conditions

Nocturnal Enuresis; Vitamin D Deficiency

Keywords

Primary monosymptomatic nocturnal enuresis; Bedwetting; Pediatric nocturnal enuresis; Desmopressin; Vitamin D supplementation; Vitamin D deficiency; Pediatric urology; Children 6-12 years; Randomized clinical trial

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Vitamin D Monotherapy

Participants receive vitamin D supplementation at a dose of 2000 IU orally once daily for 6-12 weeks, followed by a maintenance dose of 600 IU orally once daily for the remainder of the 6-month treatment period.

Group Type: EXPERIMENTAL

Vitamin D

Intervention Type: DRUG

Oral vitamin D supplementation used to correct vitamin D deficiency in children with primary monosymptomatic nocturnal enuresis.

Desmopressin Monotherapy

Participants receive desmopressin 0.2 mg orally once daily at bedtime for the full 6-month treatment period. Dose adjustments follow standard pediatric nocturnal enuresis guidance if needed.

Group Type: ACTIVE_COMPARATOR

Desmopressin

Intervention Type: DRUG

Oral desmopressin used as antidiuretic therapy for primary monosymptomatic nocturnal enuresis in children.

Combination Therapy (Vitamin D + Desmopressin)

Participants receive vitamin D supplementation (2000 IU orally once daily for 6-12 weeks, then 600 IU daily) combined with desmopressin 0.2 mg orally once daily at bedtime for a total of 6 months.

Group Type: EXPERIMENTAL

Vitamin D

Intervention Type: DRUG

Oral vitamin D supplementation used to correct vitamin D deficiency in children with primary monosymptomatic nocturnal enuresis.

Desmopressin

Intervention Type: DRUG

Oral desmopressin used as antidiuretic therapy for primary monosymptomatic nocturnal enuresis in children.

Interventions

Vitamin D

Oral vitamin D supplementation used to correct vitamin D deficiency in children with primary monosymptomatic nocturnal enuresis.

Intervention Type: DRUG

Desmopressin

Oral desmopressin used as antidiuretic therapy for primary monosymptomatic nocturnal enuresis in children.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Children and adolescents aged 6 to 12 years
• Primary monosymptomatic nocturnal enuresis
• At least 2 episodes of night-time bedwetting per week for ≥3 consecutive months
• Serum 25-hydroxyvitamin D level <20 ng/mL
• Normal kidney function
• Normal serum sodium level
• Absence of daytime lower urinary tract symptoms (urgency, frequency, dysuria)
• Informed consent from parent or guardian and assent from the child when appropriate

Exclusion Criteria

• Non-monosymptomatic nocturnal enuresis (daytime storage or voiding symptoms)
• Congenital urinary tract anomalies (e.g., meatal stenosis, hypospadias, epispadias)
• Urinary tract infection until culture becomes negative
• Neurological abnormalities, including suspected neurogenic bladder
• Endocrine diseases such as diabetes mellitus or hyperthyroidism
• Congestive heart failure or significant cardiac disease
• Prior or current use of vitamin D supplementation
• Serum sodium below normal range
• Chronic systemic illness
• Any condition judged by investigators to interfere with study participation

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Ibrahim Magdy Ibrahim Mohammed

Resident of Urology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ain Shams University Hospitals

Cairo, Cairo Governorate, Egypt

Countries

Egypt

Other Identifiers

FMASU_MS402_2025

Identifier Type: -

Identifier Source: org_study_id