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Hepatitis c and Vitamin D and Iron Status

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03166280
Acronym
hepatitisc
Enrollment
87
Registered
2017-05-25
Start date
2017-06-30
Completion date
2018-05-31
Last updated
2017-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis C

Keywords

hepatitis C, vitamin D, iron, hepcidin

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.

Interventions

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

DRUGDaclatasvir 60 mg/day

treatment for hepatitis c by Daclatasvir 60 mg/day

Sponsors

Eman Sayed Hassan Abd Allah
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
change in levels of vitamin D6 monthsSerum vitamin D (25OH vitamin D) before starting the treatment and after 6 months
Change in iron level6 monthsSerum iron level before treatment and after 6 months
Change in total iron binding capacity6 monthSerum total iron binding capacity before starting the treatment and after 6 months
Change in serum hepcidin6 monthsSerum hepcidin before starting the treatment and after 6 months

Secondary

MeasureTime frameDescription
correlate levels of vitamin D, iron, total iron binding capacity and hepcidin with sustain virologic response or any complicationsone daypearson's correlation

Contacts

Primary ContactHussein A Elamin, MD
elamin67@yahoo.com01004084184
Backup ContactSafeinaz H Kamal, MD
01007711092

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026