Hepatitis ChepatitiscNCT03166280
Hepatitis c and Vitamin D and Iron Status
An observational study of Hepatitis C, run by Eman Sayed Hassan Abd Allah.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hepatitis C
- What is being tested?
- Sofosbuvir 400 mg and Daclatasvir 60 mg/day
- How many people
- 87 participants
- Where
- No sites listed yet
- Study dates
- Jun 2017to May 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: hepatitis C ttt sofobuvir \& daclatasvir
Who may be able to join
- Naïve HCV Patients (>18Y) coming to National Committee for control of viral hepatitis to receive their treatment
Who cannot join
- 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.
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- 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
Trial locations and contacts
No sites are listed yet.
Safeinaz H Kamal, MD contact
About this study
Official title: Evaluation of Vitamin D and Iron Status in Chronic Hepatitis C Virus Patients Before and After Treatment
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.
Read the 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.
- Conditions
- Hepatitis C
- Being tested
- Sofosbuvir 400 mg, Daclatasvir 60 mg/day
- Keywords
- hepatitis C, vitamin D, iron, hepcidin
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sofosbuvir 400 mgDrug
Also called sovaldi
treatment for hepatitis c by sofosbuvir (Sovaldi) 400 mg/day
Daclatasvir 60 mg/dayDrug
Also called Daklinza
treatment for hepatitis c by Daclatasvir 60 mg/day
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Sofosbuvir 400 mg; Drug: Daclatasvir 60 mg/day |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in levels of vitamin D
Serum vitamin D (25OH vitamin D) before starting the treatment and after 6 months
Measured: 6 months
Change in iron level
Serum iron level before treatment and after 6 months
Measured: 6 months
Change in total iron binding capacity
Serum total iron binding capacity before starting the treatment and after 6 months
Measured: 6 month
Change in serum hepcidin
Serum hepcidin before starting the treatment and after 6 months
Measured: 6 months
Secondary outcomes (1)
correlate levels of vitamin D, iron, total iron binding capacity and hepcidin with sustain virologic response or any complications
pearson's correlation
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2017
- Study startJun 2017 (estimated)
- Primary completionNov 2017 (estimated)
- Study completionMay 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 87 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eman Sayed Hassan Abd Allah
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Eman Sayed Hassan Abd Allah, Assiut University
- Investigators
- Eman SH Abd Allah, PHD, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03166280
- Sponsor's protocol ID
- IRB0000871820032017
- Acronym
- hepatitisc
- Status last verified
- May 2017
- First submitted
- 14 May 2017
- Last updated
- 25 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Vitamin D and Iron Status in Chronic Hepatitis C Virus Patients Before and After Treatment
- ClinicalTrials.gov ID
- NCT03166280
- Acronym / sponsor ID
- hepatitisc / IRB0000871820032017
- Conditions
- Hepatitis C
- Keywords
- hepatitis C, vitamin D, iron, hepcidin
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 87 participants (estimated)
- Lead sponsor
- Eman Sayed Hassan Abd AllahUniversity, hospital or other
- Study start
- Jun 2017 (estimated)
- Primary completion
- Nov 2017 (estimated)
- Study completion
- May 2018 (estimated)
- First posted
- 25 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hepatitisC-pre-ttt | – | –Naïve HCV Patients (>18Y) coming to National Committee for control of viral hepatitis before receiving their treatment |
| hepatitis C-ttt | – | Drug: Sofosbuvir 400 mg, Drug: Daclatasvir 60 mg/dayNaïve 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- hepatitis C ttt sofobuvir \& daclatasvir
Key inclusion criteria (1 listed)
- Naïve HCV Patients (>18Y) coming to National Committee for control of viral hepatitis to receive their treatment
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sofosbuvir 400 mgAlso: sovalditreatment for hepatitis c by sofosbuvir (Sovaldi) 400 mg/day | Drug | hepatitis C-ttt |
| Daclatasvir 60 mg/dayAlso: Daklinzatreatment for hepatitis c by Daclatasvir 60 mg/day | Drug | hepatitis C-ttt |
Primary outcome
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
1 secondary outcome
correlate levels of vitamin D, iron, total iron binding capacity and hepcidin with sustain virologic response or any complications
Time frame: one day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Safeinaz H Kamal, MD contact
Eman SH Abd Allah, PHD principal investigator
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis C, run by Eman Sayed Hassan Abd Allah.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 May 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hussein A Elamin, MD (01004084184 ext. +2, elamin67@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in levels of vitamin D (time frame: 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2017.