Hepatitis c and Vitamin D and Iron Status

NCT ID: NCT03166280

Last Updated: 2017-05-25

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 87 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-06-30
• Study Completion Date: 2018-05-31

Brief Summary

HCV is associated with vitamin D deficiency. Iron overload is frequently occurred in chronic hepatitis C patients; more than one third of HCV positive patients have elevated serum iron, ferritin, and transferrin which were linked to bad prognosis. Hepcidin is a regulatory peptide that is mainly synthesized by the liver cells and plays an important role in iron homeostasis. There is an interaction between iron metabolism and vitamin D metabolism. Iron is essential for vitamin D activation and vitamin D deficiency is associated with elevated hepcidin level, which partly accounts for anemia associated with vitamin D deficiency. Up to our knowledge, little is known about the association between vitamin D status and iron metabolism in HCV patients.

Detailed Description

Hepatitis C virus (HCV) is one of the global public health problems. World Health Organization (WHO) reported that more than 80 million people all over the world are infected with HCV. Approximately 700000 persons die every year from hepatitis C-related complications. Egypt is one of the highest prevalence rates of HCV, worldwide.

Vitamin D possesses anti-inflammatory, anti-oxidant, anti-fibrotic and immunomodulatory effects. HCV is associated with vitamin D deficiency. Liver plays an important role in vitamin D hydroxylation and iron metabolism. It stores iron, synthesizes iron transporting protein (transferrin), iron storage protein (ferritin) and an iron regulatory peptide (hepcidin). Iron overload is frequently occurred in chronic hepatitis C patients. More than one third of HCV positive patients have elevated serum iron, ferritin, and transferrin which were linked to bad prognosis. Excess iron is catalyzed by the rapid Fenton reaction producing hydroxyl radicals from hydrogen peroxide and superoxide (10), which induces lipid peroxidation and cellular damage. Hepcidin is a regulatory peptide that is mainly synthesized by the liver cells and plays an important role in iron homeostasis via inhibiting iron absorption and preventing iron efflux from macrophages and thus prevents normal recycling of the iron needed for erythropoiesis. In addition, hepcidin inhibits HCV replication via activation of STAT3. A reduced serum hepcidin has been reported in chronic HCV patients which was correlated to the severity of liver histopathological changes and related to iron overload in these patients.

There is an interaction between iron metabolism and vitamin D metabolism. Iron is essential for vitamin D activation and vitamin D deficiency is associated with elevated hepcidin level, which partly accounts for anemia associated with vitamin D deficiency. Up to our knowledge, little is known about the association between vitamin D status and iron metabolism in HCV patients.

Conditions

Hepatitis C

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

hepatitisC-pre-ttt

Naïve HCV Patients (\>18Y) coming to National Committee for control of viral hepatitis before receiving their treatment

No interventions assigned to this group

hepatitis C-ttt

Naïve HCV Patients (\>18Y) coming to National Committee for control of viral hepatitis- 12 weeks after stoppage their treatment of sofosbuvir 400 mg/day plus Daclatasvir 60 mg/day for 12 weeks.

Sofosbuvir 400 mg

Intervention Type: DRUG

treatment for hepatitis c by sofosbuvir (Sovaldi) 400 mg/day

Daclatasvir 60 mg/day

Intervention Type: DRUG

treatment for hepatitis c by Daclatasvir 60 mg/day

Interventions

Sofosbuvir 400 mg

treatment for hepatitis c by sofosbuvir (Sovaldi) 400 mg/day

Intervention Type: DRUG

Daclatasvir 60 mg/day

treatment for hepatitis c by Daclatasvir 60 mg/day

Intervention Type: DRUG

Other Intervention Names

sovaldi; Daklinza

Eligibility Criteria

Inclusion Criteria

• Naïve HCV Patients (>18Y) coming to National Committee for control of viral hepatitis to receive their treatment

Exclusion Criteria

• Age less than 18 years old or more than 70 years old.
• previously received treatment for HCV
• Manifestations or history of manifestations of liver cell failure and cirrhosis including ascites and hepatic encephalopathy.
• Patients co-infected by the hepatitis B (HBV), human immunodeficiency viruses (HIV).
• Hepatocellular carcinoma and other extra hepatic carcinoma.
• Renal disease.
• Patients receiving vitamin D, calcium therapy or iron supplementation for the last 3 months will be excluded.
• Total serum bilirubin ≥ 3 mg/dl.
• Serum albumin < 2.8 g/dl
• international normalization ratio (INR)> 1.7
• Platelet count <50000/mm3
• Serum creatinine >2.5mg/l

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eman Sayed Hassan Abd Allah

OTHER

Sponsor Role: lead

Responsible Party

Eman Sayed Hassan Abd Allah

principle investigator, assistant professor of Medical Physiology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Eman SH Abd Allah, PHD

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Central Contacts

Hussein A Elamin, MD

Role: CONTACT

elamin67@yahoo.com

01004084184 ext. +2

Safeinaz H Kamal, MD

Role: CONTACT

01007711092 ext. +2

Other Identifiers

IRB0000871820032017

Identifier Type: -

Identifier Source: org_study_id