Hepatitis c and Vitamin D and Iron Status (hepatitisc)

May 23, 2017 updated by: Eman Sayed Hassan Abd Allah

Evaluation of Vitamin D and Iron Status in Chronic Hepatitis C Virus Patients Before and After Treatment

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

87

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Safeinaz H Kamal, MD
  • Phone Number: +2 01007711092

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

hepatitis C ttt sofobuvir & daclatasvir

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
hepatitisC-pre-ttt
Naïve HCV Patients (>18Y) coming to National Committee for control of viral hepatitis before receiving their treatment
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.
Drug: Sofosbuvir 400 mg
treatment for hepatitis c by sofosbuvir (Sovaldi) 400 mg/day
Other Names:
  • sovaldi
Drug: Daclatasvir 60 mg/day
treatment for hepatitis c by Daclatasvir 60 mg/day
Other Names:
  • Daklinza

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in levels of vitamin D
Time Frame: 6 months
Serum vitamin D (25OH vitamin D) before starting the treatment and after 6 months
6 months
Change in iron level
Time Frame: 6 months
Serum iron level before treatment and after 6 months
6 months
Change in total iron binding capacity
Time Frame: 6 month
Serum total iron binding capacity before starting the treatment and after 6 months
6 month
Change in serum hepcidin
Time Frame: 6 months
Serum hepcidin before starting the treatment and after 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
correlate levels of vitamin D, iron, total iron binding capacity and hepcidin with sustain virologic response or any complications
Time Frame: one day
pearson's correlation
one day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eman Sayed Hassan Abd Allah

Investigators

  • Principal Investigator: Eman SH Abd Allah, PHD, Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2017

Primary Completion (Anticipated)

November 1, 2017

Study Completion (Anticipated)

May 1, 2018

Study Registration Dates

First Submitted

May 14, 2017

First Submitted That Met QC Criteria

May 23, 2017

First Posted (Actual)

May 25, 2017

Study Record Updates

Last Update Posted (Actual)

May 25, 2017

Last Update Submitted That Met QC Criteria

May 23, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB0000871820032017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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