Vitamin D Level and Risk of Infections in Cirrhotic Patients

Overview

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).

Full Title of Study: “Vitamin D Level and Risk of Infections in Cirrhotic Patients: Does it Have a Role?”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: January 15, 2018

Interventions

  • Diagnostic Test: 3- Serum 25-Hydroxy Vitamin D level will be measured by Competitive ELISA technique
    • Serum 25-Hydroxy Vitamin D level will be measured by Competitive ELISA technique using CALBIOTECH (A life science company) kit, Catalog No.: VD220B

Arms, Groups and Cohorts

  • Cirrhotic patients with or without infection
    • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Vitamin D deficiency as a risk factor for infection in cirrhotic patients
    • Time Frame: 6 month
    • 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

Secondary Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Assiut University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Dr. Nahed A. Makhlouf, Assistant Professor – Assiut University
  • Overall Official(s)
    • Amal A Mahmoud, M.D, Study Director, Assiut Uiversity
  • Overall Contact(s)
    • Haidi K Ramadan, M.D, 00201005091937, Heidi_ramadan@yahoo.com

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