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NCT Number: NCT07292753

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

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.

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Key information

Conditions

Nocturnal Enuresis Avitaminosis Behavior Behavioral Symptoms Deficiency Diseases Elimination Disorders Enuresis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Malnutrition Mental Disorders Nutrition Disorders Nutritional and Metabolic Diseases Urination Disorders Urogenital Diseases Urologic Diseases Vitamin D Deficiency

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ain Shams University Hospitals

Cairo, Cairo Governorate, 11511, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin D

Drug

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

Desmopressin

Drug

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

Primary outcomes

  1. 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

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 18, 2025
Registry last updated
Mar 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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