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

Ain Shams University

Status: Completed

Conditions: Vitamin D Deficiency; Nocturnal Enuresis

Treatments: Drug: Vitamin D; Drug: Desmopressin

Study type: Interventional

Funder types: Other

Identifiers

NCT07292753

FMASU_MS402_2025

Details and patient eligibility

About

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.

Enrollment: 90 patients

Sex: All

Ages: 6 to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 3 patient groups

Vitamin D Monotherapy

Experimental group

Description:

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.

Treatment:

Drug: Vitamin D

Desmopressin Monotherapy

Active Comparator group

Description:

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.

Treatment:

Drug: Desmopressin

Combination Therapy (Vitamin D + Desmopressin)

Experimental group

Description:

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.

Treatment:

Drug: Desmopressin

Drug: Vitamin D