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

NCT07167797 | Completed DMC

• 1 other identifier: 1969
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Rotaviral Gastroenteritis

Outcome Measures

Primary Outcomes (6)

• Severity of diarrhea

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

  7 days

• Duration of diarrhea

  Duration of diarrhea will be measured by days

  7 days

• Severity of vomiting

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

  7 days

• Duration of vomiting

  Duration of vomiting will be measured by days

  7 days

• Hydration state

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

  7 days

• Temperature

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

  7 days

Secondary Outcomes (5)

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

  7 days

• C reactive protein (CRP)

  7 days

• Mean platelet volume (MPV)

  7 days

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

  7 days

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

  7 days

Study Arms (2)

Group I (control): received standard treatment which include rehydration therapy and antipyretic the

PLACEBO COMPARATOR

Group I (control): will receive standard treatment which include rehydration therapy and antipyretic therapy

Drug: Standard treatment for rotavirus

Group II (Treatment) group: received vitamin D single oral dose 300000 IU for age < 1 year and dose

EXPERIMENTAL

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. The study lasted 6 months, with follow-ups at 7-10 days

Dietary Supplement: Vitamin D (Cholecalciferol )

Interventions

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

Group II (Treatment) group: received vitamin D single oral dose 300000 IU for age < 1 year and dose

Standard treatment for rotavirus DRUG

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

Group I (control): received standard treatment which include rehydration therapy and antipyretic the

Eligibility Criteria

• Age: 3 Months - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• University of Baghdad: lead

Study Sites (1)

AL Kadhimia pediatric hospital

Baghdad, Baghdad Governorate, 00964, Iraq

Location

MeSH Terms

Interventions

Cholecalciferol

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer/ College of Pharmacy/ University of Baghdad

Study Record Dates

• First Submitted: August 21, 2025
• First Posted: September 11, 2025
• Study Start: January 1, 2025
• Primary Completion: May 1, 2025
• Study Completion: December 6, 2025
• Last Updated: December 31, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: in March 2026 and will be always available
• Access Criteria: Researchers will be able to access data from open access journal

Locations

IR (1)