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

Ain Shams University90 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Nocturnal Enuresis Vitamin D Deficiency

Eligibility

Sex: ALLMin age: 6 YearsMax age: 12 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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).

Time frame: Baseline and 3 months after initiation of therapy

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Baseline to 6 months

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes