Vitamin D Level and Risk of Infections in Cirrhotic Patients

Study Overview
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Brief Summary
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It is widely known that vitamin D has an important role in calcium metabolism and bone mineralization. Its deficiency is related to rickets and osteomalacia in children and adults respectively. Vitamin D had a role in innate and acquired immunity. It increases innate defense and modulates lymphocytes activation, leading to a change toward a T2 helper response ). The role of vitamin D deficiency on the risk of bacterial infection among patients in intensive care units has been reported. An observational studies in children reported an association between low 25-OH vitamin D level and infectious viral diseases . The deranged metabolism of vitamin D in liver cirrhosis was first reported in the late '70s and was attributed mainly to impaired 25(OH)-vitamin D hydroxylation of the precursor vitamin D caused by impaired liver function. Low level of vitamin D was found independently to be associated with increased risk of bacterial infections in patients with liver cirrhosis. The observed relationship between the lack of vitamin D and the increase risk of mortality in cirrhotic patients could be attributed to bacterial infections. Thus, the association of low vitamin D levels with liver insufficiency and infections supports the use of vitamin D as a prognostic marker in the population of cirrhosis. Studies on the role of vitamin D as a risk factor for infections in patients with liver cirrhosis are not well studied in our locality(Upper Egypt).

Official Title
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Vitamin D Level and Risk of Infections in Cirrhotic Patients: Does it Have a Role?

Conditions
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Vitamin D Deficiency, Infection, Liver Cirrhosis

Intervention / Treatment
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* Diagnostic Test: 3- Serum 25-Hydroxy Vitamin D level will be measured by Competitive ELISA technique


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Admitted patients with liver cirrhosis irrespective of the underlying etiology during 6 months in Al Rajhi Liver Hospital, Assiut, Egypt who accept to participate in the study Exclusion Criteria: Patients with cholestatic liver disease, patients receiving antibiotics to treat their infection prior hospital admission and patients refusing to participate in the study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cirrhotic patients with or without infection<br>We will include admitted patients with liver cirrhosis irrespective of the underlying etiology during 6 months in Al Rajhi Tertiary Liver Hospital, Assiut, Egypt. They will be divided into 2 Groups. Group I: Cirrhotic patients with evidence of infections at any site and Group II: Cirrhotic patients without evidence of infections. Diagnosis of infection will based on related clinical symptoms and signs with laboratory and radiological findings. | Diagnostic Test: 3- Serum 25-Hydroxy Vitamin D level will be measured by Competitive ELISA technique<br>* Serum 25-Hydroxy Vitamin D level will be measured by Competitive ELISA technique using CALBIOTECH (A life science company) kit, Catalog No.: VD220B<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vitamin D deficiency as a risk factor for infection in cirrhotic patients | Measurement of Vitamin D levels in cirrhotic with infection when compared with cirrhotic without infection and determination of Vitamin D level cut-off points for infection in cirrhotic patients | 6 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of Vitamin D level with Liver Disease severity | Correlation of Vitamin D level with Child Pugh Grade | 6 month | 
| Correlation of vitamin D level with liver disease severity | Correlation of Vitamin D level with MELD score | 6 month | 
| Determination of independent predictor of infection in cirrhotics | Use of logistic regression analysis for risk factors for infection in cirrhotic patients | 6 month |