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

What Was Tested

This registered not phased trial tested Desmopressin.

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.

It had three arms (groups): Vitamin D Monotherapy (experimental), Desmopressin Monotherapy (active comparator) and Combination Therapy (Vitamin D + Desmopressin) (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 90 actual participants took part.

It was open to people of any sex aged from 6 years up to 12 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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.

The full record lists 8 inclusion and 10 exclusion criteria; among the exclusions: 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.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

The participants were allocated by chance, so the Desmopressin group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Nothing was hidden in this open-label Desmopressin study: the participants and staff both knew the treatment.

It started in 2024-12-15 with completion listed for 2025-10-10.

It ran at 1 site in Egypt.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change in number of wet nights per week at 3 months (time frame: Baseline and 3 months after initiation of therapy).

It also tracked 9 secondary outcomes, for example Change in number of wet nights per week at 6 months, Proportion of patients with complete response at 3 and 6 months, Proportion of patients with partial response at 3 and 6 months, Change in serum sodium level, Change in serum 25-hydroxyvitamin D level and Incidence of hyponatremia.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Desmopressin in 90 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Desmopressin compound page, all human trials.