Vitamin D Level and Risk of Infections in Cirrhotic Patients
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|ClinicalTrials.gov Identifier: NCT03391245|
Recruitment Status : Unknown
Verified December 2017 by Dr. Nahed A. Makhlouf, Assiut University.
Recruitment status was: Recruiting
First Posted : January 5, 2018
Last Update Posted : January 8, 2018
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|
|Vitamin D Deficiency Infection Liver Cirrhosis||Diagnostic Test: 3- Serum 25-Hydroxy Vitamin D level will be measured by Competitive ELISA technique|
|Study Type :||Observational|
|Estimated Enrollment :||87 participants|
|Official Title:||Vitamin D Level and Risk of Infections in Cirrhotic Patients: Does it Have a Role?|
|Actual Study Start Date :||August 1, 2017|
|Estimated Primary Completion Date :||January 15, 2018|
|Estimated Study Completion Date :||February 15, 2018|
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
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03391245
|Contact: Haidi K Ramadan, M.D||00201005091937||Heidi_ramadan@yahoo.com|
|Contact: Hoda A Makhlouf, Professor 00201001529442 email@example.com|
|Study Director:||Amal A Mahmoud, M.D||Assiut Uiversity|