Clinical trial NCT03166280: Hepatitis c and Vitamin D and Iron Status
Official title: Evaluation of Vitamin D and Iron Status in Chronic Hepatitis C Virus Patients Before and After Treatment
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hepatitis C
Keywords: hepatitis C
vitamin D
iron
hepcidin
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-05-25
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: hepatitis C ttt sofobuvir \& daclatasvir

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.

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

Primary outcomes:
measure: change in levels of vitamin D
timeFrame: 6 months
measure: Change in iron level
timeFrame: 6 months
measure: Change in total iron binding capacity
timeFrame: 6 month
measure: Change in serum hepcidin
timeFrame: 6 months
Secondary outcomes:
measure: correlate levels of vitamin D, iron, total iron binding capacity and hepcidin with sustain virologic response or any complications
timeFrame: one day
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Eman SH Abd Allah, PHD
role: PRINCIPAL_INVESTIGATOR
References: