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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:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin D Monotherapy | Experimental | 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. |
|
| Desmopressin Monotherapy | Active Comparator | 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. |
|
| Combination Therapy (Vitamin D + Desmopressin) | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D | Drug | Oral vitamin D supplementation used to correct vitamin D deficiency in children with primary monosymptomatic nocturnal enuresis. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain Shams University Hospitals | Cairo | Cairo Governorate | 11511 | Egypt |
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.
Data will be available beginning 6 months after publication of the study results and will remain available for 3 years thereafter.
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.
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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.
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| Desmopressin | Drug | Oral desmopressin used as antidiuretic therapy for primary monosymptomatic nocturnal enuresis in children. |
|
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 |
| ID | Term |
|---|---|
| D053206 | Nocturnal Enuresis |
| D014808 | Vitamin D Deficiency |
| ID | Term |
|---|---|
| D004775 | Enuresis |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D019960 | Elimination Disorders |
| D001523 | Mental Disorders |
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D014807 | Vitamin D |
| D003894 | Deamino Arginine Vasopressin |
| ID | Term |
|---|---|
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D001127 | Arginine Vasopressin |
| D014667 | Vasopressins |
| D010909 | Pituitary Hormones, Posterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
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