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

NCT ID: NCT07167797

Last Updated: 2025-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-01

Study Completion Date

2025-12-06

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Rotaviral Gastroenteritis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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

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

Group Type PLACEBO_COMPARATOR

Standard treatment for rotavirus

Intervention Type DRUG

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

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

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

Group Type EXPERIMENTAL

Vitamin D (Cholecalciferol )

Intervention Type 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

Interventions

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Vitamin D (Cholecalciferol )

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

Intervention Type DIETARY_SUPPLEMENT

Standard treatment for rotavirus

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

3 Months

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Baghdad

OTHER

Sponsor Role lead

Responsible Party

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Fadia Thamir Ahmed

Lecturer/ College of Pharmacy/ University of Baghdad

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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AL Kadhimia pediatric hospital

Baghdad, Baghdad Governorate, Iraq

Site Status

Countries

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Iraq

Other Identifiers

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1969

Identifier Type: -

Identifier Source: org_study_id