Vitamin D Level and Risk of Infections in Cirrhotic Patients

NCT03391245 | Unknown

• 1 other identifier: VDLARIACP
• Study Type: observational
• Target: 87
• Locations: 1 country
• Sites: 1

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).

Conditions

Vitamin D Deficiency; Infection; Liver Cirrhosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Correlation of Vitamin D level with Liver Disease severity

  6 month

• Correlation of vitamin D level with liver disease severity

  6 month

• Determination of independent predictor of infection in cirrhotics

  6 month

Study Arms (1)

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

Interventions

3- Serum 25-Hydroxy Vitamin D level will be measured by Competitive ELISA technique DIAGNOSTIC_TEST

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

Cirrhotic patients with or without infection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Patients with cholestatic liver disease, patients receiving antibiotics to treat their infection prior hospital admission and patients refusing to participate in the study.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University

Asyut, Egypt

RECRUITING

MeSH Terms

Conditions

Vitamin D Deficiency; Infections; Liver Cirrhosis

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Amal A Mahmoud, M.D

  Assiut Uiversity

  STUDY DIRECTOR

Central Study Contacts

Haidi K Ramadan, M.D

CONTACT

00201005091937; Heidi_ramadan@yahoo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 27, 2017
• First Posted: January 5, 2018
• Study Start: August 1, 2017
• Primary Completion: January 15, 2018
• Study Completion: February 15, 2018
• Last Updated: January 8, 2018

Record last verified: 2017-12

Locations

EG (1)