Vitamin D Level and Risk of Infections in Cirrhotic Patients

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

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).

Study Overview

• Status: Unknown
• Conditions: Liver Cirrhosis; Vitamin D Deficiency; Infection
• Intervention / Treatment: Diagnostic test: 3- Serum 25-Hydroxy Vitamin D level will be measured by Competitive ELISA technique

• Study Type: Observational
• Enrollment (Anticipated): 87

Contacts and Locations

• Study Contact: Name: Haidi K Ramadan, M.D; Phone Number: 00201005091937; Email: Heidi_ramadan@yahoo.com

Study Locations

• Egypt
  • Assiut, Egypt
    • Recruiting
    • Assiut University
    • Contact: Hoda A Makhlouf, Professor; Phone Number: 00201001529442; Email: hamakhlouf@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Study Director: Amal A Mahmoud, M.D, Assiut uiversity

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2017
• Primary Completion (Anticipated): January 15, 2018
• Study Completion (Anticipated): February 15, 2018

Study Registration Dates

• First Submitted: December 27, 2017
• First Submitted That Met QC Criteria: December 30, 2017
• First Posted (Actual): January 5, 2018

Study Record Updates

• Last Update Posted (Actual): January 8, 2018
• Last Update Submitted That Met QC Criteria: January 4, 2018
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease Attributes; Liver Diseases; Nutrition Disorders; Avitaminosis; Deficiency Diseases; Malnutrition; Fibrosis; Infections; Communicable Diseases; Vitamin D Deficiency; Liver Cirrhosis; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Vitamin D; Calcifediol; Hydroxycholecalciferols
• Other Study ID Numbers: VDLARIACP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No