Rotaviral Gastroenteritis
Conditions
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.
Detailed 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.
Interventions
DIETARY_SUPPLEMENTVitamin 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
DRUGStandard treatment for rotavirus
Standard treatment for rotavirus which includes rehydration therapy and antipyretic therapy including sodium chloride fluid and paracetamol infusion
Sponsors
University of Baghdad
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Months to 5 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Temperature | 7 days | Temperature will be measured by nominal scale (1 for febrile and 0 fir afebrile patient) |
| 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| Measuring NLR at admission, after 4 days and after 7 days both groups. | 7 days | Measuring NLR at admission, after 4 days and after 7 days both groups. |
| Measuring PLR 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. |
| Measuring LMR at admission, after 4 days and after 7 days both groups. | 7 days | Measuring LMR will be done by getting ratios of blood cells from CBC test |
Countries
Iraq
Outcome results
None listed