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Completed

NCT Number: NCT07167797

Evaluation of the Role of Vitamin D in Reducing the Severity and Duration of Rotavirus Infection in Iraqi Children

The aim of this study is to evaluate the effect of vitamin D supplementation on the clinical outcomes including duration and severity of rotavirus-induced gastroenteritis in children that will be admitted to the hospital. And to evaluate the anti-inflammatory effect of vitamin D on the pediatrics with rotavirus gastroenteritis by measuring inflammatory markers such as C-reactive protein (CRP), neutrophil to lymphocyte ratio (NLR), platelet to lymphocytes ratio (PLR), lymphocytes to monocytes ratio (LMR) and mean platelet volume MPV.

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Key information

Conditions

Rotaviral Gastroenteritis

Age range

3 month–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AL Kadhimia pediatric hospital

Baghdad, Baghdad Governorate, 00964, Iraq

About this study

Evaluation of effect of vitamin D supplementation on the clinical outcomes including duration and severity of rotavirus-induced gastroenteritis in children that will be admitted to the hospital. And to evaluate the anti-inflammatory effect of vitamin D on the pediatrics with rotavirus gastroenteritis by measuring inflammatory markers such as C-reactive protein (CRP), neutrophil to lymphocyte ratio (NLR), platelet to lymphocytes ratio (PLR), lymphocytes to monocytes ratio (LMR) and mean platelet volume MPV.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Children with confirmed rotavirus infection by rotavirus stool examination by rotavirus rapid test from CerTest BIOTEC company in Spain.
  • Serum vitamin D levels indicating deficiency (below 20 ng/mL)

Exclusion criteria

  • Children with other major infections, severe dehydration or underlying health conditions.
  • Children with current vitamin D supplementation.

Treatment and study plan

Vitamin D (Cholecalciferol )

Dietary Supplement

Group II (Treatment) group: received vitamin D single oral dose 100000 IU for age < 1 year and dose of 300000IU for age> 1 year in addition to standard treatment

Standard treatment for rotavirus

Drug

Standard treatment for rotavirus which includes rehydration therapy and antipyretic therapy including sodium chloride fluid and paracetamol infusion

Primary outcomes

  1. Severity of diarrhea

    Time frame: 7 days

    severity of diarrhea will be measured by frequency of daily bowel movement

  2. Duration of diarrhea

    Time frame: 7 days

    Duration of diarrhea will be measured by days

  3. Severity of vomiting

    Time frame: 7 days

    Severity of vomiting will be measured by frequency of vomiting per day

  4. Duration of vomiting

    Time frame: 7 days

    Duration of vomiting will be measured by days

  5. Hydration state

    Time frame: 7 days

    Hydration state will be measured by score (1 fore well hydrated,2 for mild dehydration, 3 for moderate dehydration and 4 for severe dehydration)

  6. Temperature

    Time frame: 7 days

    Temperature will be measured by nominal scale (1 for febrile and 0 fir afebrile patient)

Secondary outcomes

  1. Measuring LMR at admission, after 4 days and after 7 days both groups.

    Time frame: 7 days

    Measuring LMR will be done by getting ratios of blood cells from CBC test

  2. C reactive protein (CRP)

    Time frame: 7 days

    CRP will be measured in mg/dl by CRP agglutination test

  3. Mean platelet volume (MPV)

    Time frame: 7 days

    Mean platelet volume (MPV) will be measured in femtoliter (fL)

  4. Measuring NLR at admission, after 4 days and after 7 days both groups.

    Time frame: 7 days

    Measuring NLR at admission, after 4 days and after 7 days both groups.

  5. Measuring PLR at admission, after 4 days and after 7 days both groups.

    Time frame: 7 days

    Measuring PLR at admission, after 4 days and after 7 days both groups.

Sponsors and collaborators

Lead sponsor

University of Baghdad

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Sep 11, 2025
Registry last updated
Dec 31, 2025

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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