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

Role of Vitamin D Supplementation Versus Desmopressin Versus Their Combination in the Treatment of Primary Monosymptomatic Nocturnal Enuresis in Children With Vitamin D Deficiency: A Randomized Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Vitamin D Deficiency; Nocturnal Enuresis
• Intervention / Treatment: Drug: Vitamin D; Drug: Desmopressin

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo Governorate
    • Cairo, Cairo Governorate, Egypt, 11511
      • Ain shams university hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Vitamin D; Oral vitamin D supplementation used to correct vitamin D deficiency in children with primary monosymptomatic nocturnal enuresis.
Active Comparator: 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.	Drug: Desmopressin; Oral desmopressin used as antidiuretic therapy for primary monosymptomatic nocturnal enuresis in children.
Experimental: 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.	Drug: Vitamin D; Oral vitamin D supplementation used to correct vitamin D deficiency in children with primary monosymptomatic nocturnal enuresis.; Drug: Desmopressin; Oral desmopressin used as antidiuretic therapy for primary monosymptomatic nocturnal enuresis in children.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in number of wet nights per week at 6 months	Mean change in the number of nocturnal enuresis episodes per week from baseline to 6 months after starting treatment, comparing the three treatment groups.	Baseline and 6 months after initiation of therapy
Proportion of patients with complete response at 3 and 6 months	Percentage of participants who achieve complete response, defined as 0 wet nights per week compared with baseline.	3 months and 6 months after initiation of therapy
Proportion of patients with partial response at 3 and 6 months	Percentage of participants who achieve partial response, defined as a ≥50% reduction in the number of wet nights per week compared with baseline.	3 months and 6 months after initiation of therapy
Change in serum sodium level	Mean change in serum sodium concentration from baseline to follow-up visits and proportion of patients developing hyponatremia in each treatment group.	Baseline, 1 week, 1 month, 3 months, and 6 months after initiation of desmopressin therapy
Change in serum 25-hydroxyvitamin D level	Mean change in serum 25(OH) vitamin D concentration from baseline to follow-up visits in each treatment group.	Baseline, 1 month, 3 months, and 6 months after initiation of therapy
Incidence of hyponatremia	Number and percentage of participants who develop hyponatremia (serum sodium below normal range) during the study period.	Baseline to 6 months after initiation of therapy
Incidence of headache	Number and percentage of participants reporting headache that begins after treatment initiation and is considered treatment-related.	Baseline to 6 months
Incidence of gastrointestinal symptoms	Number and percentage of participants reporting nausea, abdominal discomfort, or other gastrointestinal symptoms considered related to treatment.	Baseline to 6 months
Incidence of polyuria	Number and percentage of participants who develop polyuria or clinically significant increase in urine output associated with therapy.	Baseline to 6 months

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2024
• Primary Completion (Actual): October 10, 2025
• Study Completion (Actual): October 10, 2025

Study Registration Dates

• First Submitted: December 6, 2025
• First Submitted That Met QC Criteria: December 6, 2025
• First Posted (Actual): December 18, 2025

Study Record Updates

• Last Update Posted (Actual): March 17, 2026
• Last Update Submitted That Met QC Criteria: March 14, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Randomized clinical trial; Vitamin D deficiency; Pediatric urology; Desmopressin; Vitamin D supplementation; Bedwetting; Primary monosymptomatic nocturnal enuresis; Pediatric nocturnal enuresis; Children 6-12 years
• Additional Relevant MeSH Terms: Urogenital Diseases; Mental Disorders; Nutrition Disorders; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urination Disorders; Behavioral Symptoms; Elimination Disorders; Avitaminosis; Deficiency Diseases; Malnutrition; Behavior; Nutritional and Metabolic Diseases; Enuresis; Vitamin D Deficiency; Nocturnal Enuresis; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptide Hormones; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Polycyclic Compounds; Steroids; Fused-Ring Compounds; Pituitary Hormones, Posterior; Pituitary Hormones; Secosteroids; Arginine Vasopressin; Vasopressins; Vitamin D; Deamino Arginine Vasopressin
• Other Study ID Numbers: FMASU MS 175/2026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data (IPD) underlying the study results may be shared with qualified researchers upon reasonable request. Shared data will include variables necessary to confirm the primary and secondary outcome analyses. No information that could identify participants will be provided.
• IPD Sharing Time Frame: Data will be available beginning 6 months after publication of the study results and will remain available for 3 years thereafter.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No