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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
Sponsor:
Information provided by (Responsible Party):
Eman Sayed Hassan Abd Allah, Assiut University

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.

Condition or disease Intervention/treatment
Hepatitis C Drug: Sofosbuvir 400 mg Drug: Daclatasvir 60 mg/day

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.


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Study Type : Observational
Estimated Enrollment : 87 participants
Observational Model: Other
Time Perspective: Cross-Sectional
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

Resource links provided by the National Library of Medicine


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 Name: sovaldi

Drug: Daclatasvir 60 mg/day
treatment for hepatitis c by Daclatasvir 60 mg/day
Other Name: Daklinza




Primary Outcome Measures :
  1. change in levels of vitamin D [ Time Frame: 6 months ]
    Serum vitamin D (25OH vitamin D) before starting the treatment and after 6 months

  2. Change in iron level [ Time Frame: 6 months ]
    Serum iron level before treatment and after 6 months

  3. Change in total iron binding capacity [ Time Frame: 6 month ]
    Serum total iron binding capacity before starting the treatment and after 6 months

  4. Change in serum hepcidin [ Time Frame: 6 months ]
    Serum hepcidin before starting the treatment and after 6 months


Secondary Outcome Measures :
  1. 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
serum


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
hepatitis C ttt sofobuvir & daclatasvir
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

Information from the National Library of Medicine

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


Contacts
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Contact: Hussein A Elamin, MD 01004084184 ext +2 elamin67@yahoo.com
Contact: Safeinaz H Kamal, MD 01007711092 ext +2

Sponsors and Collaborators
Eman Sayed Hassan Abd Allah
Investigators
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Principal Investigator: Eman SH Abd Allah, PHD Assiut University

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Responsible Party: Eman Sayed Hassan Abd Allah, principle investigator, assistant professor of Medical Physiology, Assiut University
ClinicalTrials.gov Identifier: NCT03166280     History of Changes
Other Study ID Numbers: IRB0000871820032017
First Posted: May 25, 2017    Key Record Dates
Last Update Posted: May 25, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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

Keywords provided by Eman Sayed Hassan Abd Allah, Assiut University:
hepatitis C
vitamin D
iron
hepcidin

Additional relevant MeSH terms:
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Hepatitis
Hepatitis A
Hepatitis C
Hepatitis, Viral, Human
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Vitamins
Vitamin D
Ergocalciferols
Sofosbuvir
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents
Antiviral Agents
Anti-Infective Agents