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

Not Applicable

Active, not recruiting

• Conditions: Rotaviral Gastroenteritis
• Interventions: Drug: Standard treatment for rotavirus; Dietary Supplement: Vitamin D (Cholecalciferol )

• Registration Number: NCT07167797
• Lead Sponsor: University of Baghdad

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 CRP, NLR, PLR, LMR and MPV.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-01-01
• Primary Completion: 2025-05-01
• Study First Submitted: 2025-08-21
• Status Verified: 2025-09
• Study First Submitted QC: 2025-09-03
• Last Update Submitted: 2025-09-03
• Study Completion: 2025-09-06
• Study First Posted: 2025-09-11
• Last Update Posted: 2025-09-11

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group I (control): received standard treatment which include rehydration therapy and antipyretic the	Standard treatment for rotavirus	Group I (control): will receive standard treatment which include rehydration therapy and antipyretic therapy
Group II (Treatment) group: received vitamin D single oral dose 300000 IU for age < 1 year and dose	Vitamin D (Cholecalciferol )	Group II (Treatment) group: received vitamin D single oral dose 300000 IU for age \< 1 year and dose of 600000IU for age\> 1 year in addition to standard treatment. The study lasted 6 months, with follow-ups at 7-10 days

Primary Outcome Measures

Name	Time	Method
Severity of diarrhea	7 days	severity of diarrhea will be measured by frequency of daily bowel movement
Duration of diarrhea	7 days	Duration of diarrhea will be measured by days
Severity of vomiting	7 days	Severity of vomiting will be measured by frequency of vomiting per day
Duration of vomiting	7 days	Duration of vomiting will be measured by days
Hydration state	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)
Temperature	7 days	Temperature will be measured by nominal scale (1 for febrile and 0 fir afebrile patient)

Secondary Outcome Measures

Name	Time	Method
Measuring LMR, NLR and PLR at admission, after 4 days and after 7 days both groups.	7 days	Measuring LMR, NLR, and PLR will be done by getting ratios of blood cells from CBC test
C reactive protein (CRP)	7 days	CRP will be measured in mg/dl by CRP agglutination test
Mean platelet volume (MPV)	7 days	Mean platelet volume (MPV) will be measured in femtoliter (fL)

Trial Locations

Locations (1)

AL Kadhimia pediatric hospital; 🇮🇶 Baghdad, Baghdad Governorate, Iraq