Hepatitis c and Vitamin D and Iron Status (hepatitisc)
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|ClinicalTrials.gov Identifier: NCT03166280|
Recruitment Status : Not yet recruiting
First Posted : May 25, 2017
Last Update Posted : May 25, 2017
|Condition or disease||Intervention/treatment|
|Hepatitis C||Drug: Sofosbuvir 400 mg Drug: Daclatasvir 60 mg/day|
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|
|Estimated Enrollment :||87 participants|
|Official Title:||Evaluation of Vitamin D and Iron Status in Chronic Hepatitis C Virus Patients Before and After Treatment|
|Estimated Study Start Date :||June 2017|
|Estimated Primary Completion Date :||November 2017|
|Estimated Study Completion Date :||May 2018|
Naïve HCV Patients (>18Y) coming to National Committee for control of viral hepatitis before receiving their treatment
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 Name: sovaldi
Drug: Daclatasvir 60 mg/day
treatment for hepatitis c by Daclatasvir 60 mg/day
Other Name: Daklinza
- change in levels of vitamin D [ Time Frame: 6 months ]Serum vitamin D (25OH vitamin D) before starting the treatment and after 6 months
- Change in iron level [ Time Frame: 6 months ]Serum iron level before treatment and after 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
- Change in serum hepcidin [ Time Frame: 6 months ]Serum hepcidin before starting the treatment and after 6 months
- 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
Biospecimen Retention: Samples Without DNA
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): NCT03166280
|Contact: Hussein A Elamin, MD||01004084184 ext +email@example.com|
|Contact: Safeinaz H Kamal, MD||01007711092 ext +2|
|Principal Investigator:||Eman SH Abd Allah, PHD||Assiut University|