Hepatitis c and Vitamin D and Iron Status

NCT03166280 | Unknown DMC FDA Drug

• 1 other identifier: IRB0000871820032017
• Study Type: observational
• Target: 87
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hepatitis C

Keywords

hepatitis C; vitamin D; iron; hepcidin

Outcome Measures

Primary Outcomes (4)

• change in levels of vitamin D

  Serum vitamin D (25OH vitamin D) before starting the treatment and after 6 months

  6 months

• Change in iron level

  Serum iron level before treatment and after 6 months

  6 months

• Change in total iron binding capacity

  Serum total iron binding capacity before starting the treatment and after 6 months

  6 month

• Change in serum hepcidin

  Serum hepcidin before starting the treatment and after 6 months

  6 months

Secondary Outcomes (1)

• correlate levels of vitamin D, iron, total iron binding capacity and hepcidin with sustain virologic response or any complications

  one day

Study Arms (2)

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; Drug: Daclatasvir 60 mg/day

Interventions

Sofosbuvir 400 mg DRUG

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

Also known as: sovaldi

hepatitis C-ttt

Daclatasvir 60 mg/day DRUG

treatment for hepatitis c by Daclatasvir 60 mg/day

Also known as: Daklinza

hepatitis C-ttt

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

hepatitis C ttt sofobuvir \& daclatasvir

You may qualify if:

• Naïve HCV Patients (\>18Y) coming to National Committee for control of viral hepatitis to receive their treatment

You may not qualify if:

• 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

Sponsors & Collaborators

• Eman Sayed Hassan Abd Allah: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum

MeSH Terms

Conditions

Hepatitis C

Interventions

Sofosbuvir; daclatasvir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Uridine Monophosphate; Uracil Nucleotides; Pyrimidine Nucleotides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides

Study Officials

• Eman SH Abd Allah, PHD

  Assiut University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hussein A Elamin, MD

CONTACT

01004084184; elamin67@yahoo.com

Safeinaz H Kamal, MD

CONTACT

01007711092

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: principle investigator, assistant professor of Medical Physiology

Study Record Dates

• First Submitted: May 14, 2017
• First Posted: May 25, 2017
• Study Start: June 1, 2017
• Primary Completion: November 1, 2017
• Study Completion: May 1, 2018
• Last Updated: May 25, 2017

Record last verified: 2017-05