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

University of Baghdad

Status: Completed

Conditions: Rotaviral Gastroenteritis

Treatments: Drug: Standard treatment for rotavirus; Dietary Supplement: Vitamin D (Cholecalciferol )

Study type: Interventional

Funder types: Other

Identifiers

NCT07167797

1969

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 60 patients

Sex: All

Ages: 3 months to 5 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups, including a placebo group

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

Placebo Comparator group

Description:

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

Treatment:

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

Description:

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

Treatment:

Dietary Supplement: Vitamin D (Cholecalciferol )