Vitamin D Level and Risk of Infections in Cirrhotic Patients

Sponsor
Assiut University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03391245
Collaborator
(none)
87
1
6.5
13.4

Study Details

Study Description

Brief Summary

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).

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: 3- Serum 25-Hydroxy Vitamin D level will be measured by Competitive ELISA technique

Study Design

Study Type:
Observational
Anticipated Enrollment :
87 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Vitamin D Level and Risk of Infections in Cirrhotic Patients: Does it Have a Role?
Actual Study Start Date :
Aug 1, 2017
Anticipated Primary Completion Date :
Jan 15, 2018
Anticipated Study Completion Date :
Feb 15, 2018

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Vitamin D deficiency as a risk factor for infection in cirrhotic patients [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 Outcome Measures

  1. Correlation of Vitamin D level with Liver Disease severity [6 month]

    Correlation of Vitamin D level with Child Pugh Grade

  2. Correlation of vitamin D level with liver disease severity [6 month]

    Correlation of Vitamin D level with MELD score

  3. Determination of independent predictor of infection in cirrhotics [6 month]

    Use of logistic regression analysis for risk factors for infection in cirrhotic patients

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Assiut University Assiut Egypt

Sponsors and Collaborators

  • Assiut University

Investigators

  • Study Director: Amal A Mahmoud, M.D, Assiut Uiversity

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dr. Nahed A. Makhlouf, Assistant Professor, Assiut University
ClinicalTrials.gov Identifier:
NCT03391245
Other Study ID Numbers:
  • VDLARIACP
First Posted:
Jan 5, 2018
Last Update Posted:
Jan 8, 2018
Last Verified:
Dec 1, 2017
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 8, 2018