Vitamin D Level and Risk of Infections in Cirrhotic Patients

Vitamin D Deficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03391245
• Other study ID #: VDLARIACP
• Status: Recruiting
• Phase: N/A
• First received: December 27, 2017
• Last updated: January 4, 2018
• Start date: August 1, 2017
• Est. completion date: February 15, 2018

Study information

• Verified date: December 2017
• Source: Assiut University
• Contact: Haidi K Ramadan, M.D
• Phone: 00201005091937
• Email: Heidi_ramadan[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 87
• Est. completion date: February 15, 2018
• Est. primary completion date: January 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Liver Cirrhosis
• Vitamin D Deficiency

Intervention

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

Locations

Country	Name	City	State
Egypt	Assiut University	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Correlation of Vitamin D level with Liver Disease severity	Correlation of Vitamin D level with Child Pugh Grade	6 month
Secondary	Correlation of vitamin D level with liver disease severity	Correlation of Vitamin D level with MELD score	6 month
Secondary	Determination of independent predictor of infection in cirrhotics	Use of logistic regression analysis for risk factors for infection in cirrhotic patients	6 month