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

NCT07292753 | Completed

• 1 other identifier: FMASU MS 175/2026
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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. 1.vitamin D supplementation alone,
2. 2.desmopressin alone, or
3. 3.a combination of vitamin D and desmopressin.

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

Outcome Measures

Primary Outcomes (1)

• Change in number of wet nights per week at 3 months

  Mean change in the number of nocturnal enuresis (bedwetting) episodes per week from baseline to 3 months after starting treatment, comparing the three groups (vitamin D alone, desmopressin alone, and combination therapy).

  Baseline and 3 months after initiation of therapy

Secondary Outcomes (9)

• Change in number of wet nights per week at 6 months

  Baseline and 6 months after initiation of therapy

• Proportion of patients with complete response at 3 and 6 months

  3 months and 6 months after initiation of therapy

• Proportion of patients with partial response at 3 and 6 months

  3 months and 6 months after initiation of therapy

• Change in serum sodium level

  Baseline, 1 week, 1 month, 3 months, and 6 months after initiation of desmopressin therapy

• Change in serum 25-hydroxyvitamin D level

  Baseline, 1 month, 3 months, and 6 months after initiation of therapy

Study Arms (3)

Vitamin D Monotherapy

EXPERIMENTAL

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.

Drug: Vitamin D

Desmopressin Monotherapy

ACTIVE COMPARATOR

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.

Drug: Desmopressin

Combination Therapy (Vitamin D + Desmopressin)

EXPERIMENTAL

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.

Drug: Vitamin D; Drug: Desmopressin

Interventions

Vitamin D DRUG

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

Combination Therapy (Vitamin D + Desmopressin); Vitamin D Monotherapy

Desmopressin DRUG

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

Combination Therapy (Vitamin D + Desmopressin); Desmopressin Monotherapy

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University Hospitals

Cairo, Cairo Governorate, 11511, Egypt

Location

MeSH Terms

Conditions

Nocturnal Enuresis; Vitamin D Deficiency

Interventions

Vitamin D; Deamino Arginine Vasopressin

Condition Hierarchy (Ancestors)

Enuresis; 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; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Arginine Vasopressin; Vasopressins; Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of Urology

Model Details: Three-arm parallel-group randomized trial comparing vitamin D alone, desmopressin alone, and their combination in children with primary monosymptomatic nocturnal enuresis and vitamin D deficiency.

Study Record Dates

• First Submitted: December 6, 2025
• First Posted: December 18, 2025
• Study Start: December 15, 2024
• Primary Completion: October 10, 2025
• Study Completion: October 10, 2025
• Last Updated: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Data will be available beginning 6 months after publication of the study results and will remain available for 3 years thereafter.
• Access Criteria: Researchers must submit a methodologically sound proposal outlining the intended use of the data. Access will be granted after review and approval by the study's principal investigator and the ethics committee. A data use agreement will be required before data are released.

Locations

EG (1)