Nocturnal Enuresis, Vitamin D Deficiency
Conditions
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
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.
Interventions
DRUGVitamin D
Oral vitamin D supplementation used to correct vitamin D deficiency in children with primary monosymptomatic nocturnal enuresis.
DRUGDesmopressin
Oral desmopressin used as antidiuretic therapy for primary monosymptomatic nocturnal enuresis in children.
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
6 Years to 12 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in number of wet nights per week at 3 months | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in number of wet nights per week at 6 months | 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 | 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 | 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 | 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 | 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 | 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 | 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 | Baseline to 6 months | Number and percentage of participants reporting nausea, abdominal discomfort, or other gastrointestinal symptoms considered related to treatment. |
| Incidence of polyuria | Baseline to 6 months | Number and percentage of participants who develop polyuria or clinically significant increase in urine output associated with therapy. |
Countries
Egypt
Outcome results
None listed