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NCT Number: NCT06243042

Vitamin D Serum Levels in Monosymptomatic Enuretic and Non Enuretic Children

We are group of researchers interested in causes and management of nocturnal enuresis, we embarked on this research on 2020 and we reached promising results regarding the role of vitamin D serum level in etiology and management of monosymptomatic enuresis.

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Key information

Conditions

Nocturnal Enuresis Behavior Behavioral Symptoms Elimination Disorders Enuresis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Mental Disorders Urination Disorders Urogenital Diseases Urologic Diseases

Age range

5 year–15 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Cairo

Cairo, 11373, Egypt

About this study

this research was conducted as a comparative study regarding serum vitamin D levels in monosymptomatic enuretic and non enuretic children, also we compared urine osmolality and nocturnal polyuria in both groups and we found that low vitamin D levels are correlated with low nocturnal urine osmolality and increased incidence of nocturnal polyuria

Who can participate

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

Inclusion criteria

  • Patients with PMNE.
  • which was defined as bedwetting frequency of 3 or more nights per week for at least 2 weeks of observation.
  • Didn't receive any previous treatment for enuresis.

Exclusion criteria

  • Patients with non-monosymptomatic enuresis (associated with storage and/or voiding symptoms). -Patients with anatomical abnormalities (Meatal stenosis, Hypospadias, Epispadias, etc.).
  • Patients with neurological diseases.
  • Patients with Renal impairment.
  • Patient with previous pelvic, urological or brain and spinal cord surgery.
  • Patients with chronic constipation and irritable bowel habits.
  • Patients with active urinary tract infection.
  • Patients who are on vitamin D supplements.

Treatment and study plan

serum vitamin D

Diagnostic Test

blood sample for serum vitamin D level Vitamin D serum level was measures using the ELISA technique. The Cal Biotech Vitamin D Kit (Mannheim, Germany) was used, which is a solid phase enzyme linked immunoassay (ELISA), based on the principal of competitive binding. Vitamin D deficiency was defined as serum Vit. D below 20 ng/ml.

urine osmolality

Diagnostic Test

nocturnal urine osmolality: Clear instructions for mothers were to let the child void before sleep and every two hours till 8 am. Short intervals were meant to avoid enuretic episodes during calculation of nocturnal urine volume, and if occurred it mandates the repeat of chart on another day.

Nocturnal urine collected over the night was tested for osmolality, it was measured in mOsm/kg.

Frequency volume chart

Other

volume and frequency from time of sleep till 8 am

Primary outcomes

  1. Vitamin D level

    Time frame: through study completion, average 1 year.

    low vitamin d levels in enuretic group

Secondary outcomes

  1. nocturnal polyuria

    Time frame: through study completion, average 1 year.

    frequency volume chart idobtained

  2. low nocturnal urine osmolality

    Time frame: through study completion, average 1 year.

    nocturnal urine osmolality

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

A Comparative Study of Vitamin D Serum Levels in Monosymptomatic Enuretic Children and Non-enuretic Children

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Feb 6, 2024
Registry last updated
Feb 6, 2024

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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