Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Vitamin D Level and Risk of Infections in Cirrhotic Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
Dr. Nahed A. Makhlouf, Assiut University

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
Vitamin D Deficiency Infection Liver Cirrhosis Diagnostic Test: 3- Serum 25-Hydroxy Vitamin D level will be measured by Competitive ELISA technique

Layout table for study information
Study Type : Observational
Estimated 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 : August 1, 2017
Estimated Primary Completion Date : January 15, 2018
Estimated Study Completion Date : February 15, 2018

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Correlation of Vitamin D level with Liver Disease severity [ Time Frame: 6 month ]
    Correlation of Vitamin D level with Child Pugh Grade

  2. Correlation of vitamin D level with liver disease severity [ Time Frame: 6 month ]
    Correlation of Vitamin D level with MELD score

  3. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Haidi K Ramadan, M.D 00201005091937 Heidi_ramadan@yahoo.com

Locations
Layout table for location information
Egypt
Assiut University Recruiting
Assiut, Egypt
Contact: Hoda A Makhlouf, Professor    00201001529442    hamakhlouf@yahoo.com   
Sponsors and Collaborators
Assiut University
Investigators
Layout table for investigator information
Study Director: Amal A Mahmoud, M.D Assiut Uiversity
Layout table for additonal information
Responsible Party: Dr. Nahed A. Makhlouf, Assistant Professor, Assiut University
ClinicalTrials.gov Identifier: NCT03391245    
Other Study ID Numbers: VDLARIACP
First Posted: January 5, 2018    Key Record Dates
Last Update Posted: January 8, 2018
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Infection
Communicable Diseases
Liver Cirrhosis
Vitamin D Deficiency
Liver Diseases
Digestive System Diseases
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamin D
Hydroxycholecalciferols
Calcifediol
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents