DRUG
Vitamin D
Oral vitamin D supplementation used to correct vitamin D deficiency in children with primary monosymptomatic nocturnal enuresis.
Vitamin D Versus Desmopressin Versus Combination Therapy in Children With Primary Monosymptomatic Nocturnal Enuresis and Vitamin D Deficiency
Status
Completed
Phase
Not applicable
Enrollment
90
Locations
1
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
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.
Interventions
Treatment arms and agents.
DRUG
Desmopressin
Oral desmopressin used as antidiuretic therapy for primary monosymptomatic nocturnal enuresis in children.
Timeline
From registration to results.
First posted
Dec 18, 2025
Study start
Dec 15, 2024
Primary completion
Oct 10, 2025
Study completion
Oct 10, 2025
Results posted
Not reported
Registry updated
Mar 17, 2026
Outcomes
What the study measures.
Primary outcomes
Change in number of wet nights per week at 3 months
Time frame · Baseline and 3 months after initiation of therapy
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).
Secondary outcomes
Change in number of wet nights per week at 6 months
Time frame · Baseline and 6 months after initiation of therapy
Mean change in the number of nocturnal enuresis episodes per week from baseline to 6 months after starting treatment, comparing the three treatment groups.
Proportion of patients with complete response at 3 and 6 months
Time frame · 3 months and 6 months after initiation of therapy
Percentage of participants who achieve complete response, defined as 0 wet nights per week compared with baseline.
Proportion of patients with partial response at 3 and 6 months
Time frame · 3 months and 6 months after initiation of therapy
Percentage of participants who achieve partial response, defined as a ≥50% reduction in the number of wet nights per week compared with baseline.
Change in serum sodium level
Time frame · Baseline, 1 week, 1 month, 3 months, and 6 months after initiation of desmopressin therapy
Mean change in serum sodium concentration from baseline to follow-up visits and proportion of patients developing hyponatremia in each treatment group.
Change in serum 25-hydroxyvitamin D level
Time frame · Baseline, 1 month, 3 months, and 6 months after initiation of therapy
Mean change in serum 25(OH) vitamin D concentration from baseline to follow-up visits in each treatment group.
Incidence of hyponatremia
Time frame · Baseline to 6 months after initiation of therapy
Number and percentage of participants who develop hyponatremia (serum sodium below normal range) during the study period.
Incidence of headache
Time frame · Baseline to 6 months
Number and percentage of participants reporting headache that begins after treatment initiation and is considered treatment-related.
Incidence of gastrointestinal symptoms
Time frame · Baseline to 6 months
Number and percentage of participants reporting nausea, abdominal discomfort, or other gastrointestinal symptoms considered related to treatment.
Incidence of polyuria
Time frame · Baseline to 6 months
Number and percentage of participants who develop polyuria or clinically significant increase in urine output associated with therapy.
Eligibility
Who can take part.
- Minimum age
- 6 Years
- Maximum age
- 12 Years
- Sex
- ALL
- Healthy volunteers
- No
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 locations
1 registered sites.
Egypt. Showing up to 24 locations stored in the fast local snapshot.
Ain Shams University Hospitals
Cairo, Cairo Governorate, Egypt
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
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Put the record in context.
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