Chronic Hepatitis CPhase 3VD-HCVNCT01997203
Long Term Vitamin D Therapy in HCV Treated Patients
A Phase 3 study testing Vitamin D in people with Chronic Hepatitis C, run by Dr. Nadia AbdelAaty AbdelKader at 2 sites in Egypt.
Trial summary
Treatment of hepatitis C virus (HCV) infection was carried out using pegylated interferon (PEG-IFN), ribavirin (RBV) and vitamin D (vit D) for 48 weeks in HCV genotypes 4a subjects. The purpose of this study is to determine the effect of vitamin D on liver affection in such patients. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Chronic Hepatitis C
- What is being tested?
- Vitamin D
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesEgypt
- Study dates
- Apr 2012to Apr 2013
- Phase
- Phase 3
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Chronic HCV infection (positive HCV Ab more than 6 months)
- Treated with pegylated interferon and ribavirin
Who cannot join
- Coinfection with Hepatitis B or Hepatitis D or Human Immunodeficiency Virus
- Previous non response to antiviral therapy.
- Other causes of chronic liver diseases as schistosomiasis, Wilson disease and alcoholic liver disease.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Tropical Medicine department, Bny swif university
Bny Swif, Bny Swif
Medical biochemistry department, Cairo university
Cairo, Cairo Governorate
About this study
Official title: Effect of Long-term Vitamin D Therapy on IL-6, Visfatin and Hyaluronic Acid in Hepatitis C Virus Patients' Assessment
Treatment of hepatitis C virus (HCV) infection was carried out using pegylated interferon (PEG-IFN), ribavirin (RBV) and vitamin D (vit D) for 48 weeks in HCV genotypes 4a subjects. The purpose of this study is to determine the effect of vitamin D on liver affection in such patients.
Read the detailed description
Fifty patients study group administered vit D were compared with 50 patients control group without vit D. The results showed a significant elevation in vit D levels during the time period, and significant reduction on HCV RNA from the 12th wk to reach zero level in 24th wk. Interleukin 6 (IL-6), visfatin and hyaluronic acid levels were reduced significantly to reach normal values. These concentrations reduction by the effect of vit D on HCV indicated the reduction in inflammation, infection and liver cirrhosis and nearly amelioration HCV.
- Conditions
- Chronic Hepatitis C
- Being tested
- Vitamin D
- Keywords
- hepatitis C infection, vitamin D
- Medical subject headings
- Hepatitis C, Chronic, Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin DDrug
Also called pegylated interferon, ribavirin
vitamin D was given to 50 patients (HCV under treatment)
| Study group | Role | What they receive |
|---|---|---|
| HCV patients under treatment | Experimental | Fifty patients study group administered vitamin D were compared with 50 patients control group without vitamin D.
Dose of vitamin D 15,000 IU/week Receives: Drug: Vitamin D |
| HCV without Vit D | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
composite measures of Vitamin D, IL-6, Visfatin and Hyaluronic acid in Hepatitis C Virus Patients under antiviral therapy
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2013 (estimated)
- Study startApr 2012
- Primary completionApr 2013
- Study completionApr 2013
Why it stopped: complete patients samples required
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Nadia AbdelAaty AbdelKader
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. Nadia AbdelAaty AbdelKader, Ain Shams University
- Investigators
- Dina Sabry, Principal investigator, Medical biochemistry, Cairo universityMohamed M Tawfic, Study chair, Tropical Medicine department, bny swif universityYehia M Korriem, Study chair, Tropical Medicine department, bny swif universityNadia A Abdelkader, Study chair, Tropical Medicine department, Ain Shams universityAmany Y Elkazaz, Study chair, Medical Biochemistry, faculty of Medicine Suez Canal UniversityMohamed Ghussin, Study chair, Biochemistry department, faculty of Pharmacology Ghazza University.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01997203
- Sponsor's protocol ID
- HCV-VD2013
- Acronym
- VD-HCV
- Status last verified
- Nov 2013
- First submitted
- 19 Nov 2013
- Last updated
- 28 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Long-term Vitamin D Therapy on IL-6, Visfatin and Hyaluronic Acid in Hepatitis C Virus Patients' Assessment
- ClinicalTrials.gov ID
- NCT01997203
- Acronym / sponsor ID
- VD-HCV / HCV-VD2013
- Conditions
- Chronic Hepatitis C
- Keywords
- hepatitis C infection, vitamin D
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: complete patients samples required
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Dr. Nadia AbdelAaty AbdelKaderUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 28 Nov 2013 (estimated)
- 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.
Treatment of hepatitis C virus (HCV) infection was carried out using pegylated interferon (PEG-IFN), ribavirin (RBV) and vitamin D (vit D) for 48 weeks in HCV genotypes 4a subjects. The purpose of this study is to determine the effect of vitamin D on liver affection in such patients.
Detailed description
Fifty patients study group administered vit D were compared with 50 patients control group without vit D. The results showed a significant elevation in vit D levels during the time period, and significant reduction on HCV RNA from the 12th wk to reach zero level in 24th wk. Interleukin 6 (IL-6), visfatin and hyaluronic acid levels were reduced significantly to reach normal values. These concentrations reduction by the effect of vit D on HCV indicated the reduction in inflammation, infection and liver cirrhosis and nearly amelioration HCV.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HCV patients under treatment | Experimental | Drug: Vitamin DFifty patients study group administered vitamin D were compared with 50 patients control group without vitamin D. Dose of vitamin D 15,000 IU/week |
| HCV without Vit D | No intervention | – |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Chronic HCV infection (positive HCV Ab more than 6 months)
- Treated with pegylated interferon and ribavirin
Key exclusion criteria (3 listed)
- Coinfection with Hepatitis B or Hepatitis D or Human Immunodeficiency Virus
- Previous non response to antiviral therapy.
- Other causes of chronic liver diseases as schistosomiasis, Wilson disease and alcoholic liver disease.
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 |
|---|---|---|
| Vitamin DAlso: pegylated interferon, ribavirinvitamin D was given to 50 patients (HCV under treatment) | Drug | HCV patients under treatment |
Primary outcome
composite measures of Vitamin D, IL-6, Visfatin and Hyaluronic acid in Hepatitis C Virus Patients under antiviral therapy
Time frame: 48 weeks
Results and safety
The study was stopped early (reason given: complete patients samples required). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2013.
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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.
Dina Sabry principal investigator
Medical biochemistry, Cairo university
Mohamed M Tawfic study chair
Tropical Medicine department, bny swif university
Yehia M Korriem study chair
Tropical Medicine department, bny swif university
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Vitamin D in people with Chronic Hepatitis C, run by Dr. Nadia AbdelAaty AbdelKader at 2 sites in Egypt.
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 2 inclusion and 3 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: stopped early, as of the sponsor's last update on 28 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: complete patients samples required). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
composite measures of Vitamin D, IL-6, Visfatin and Hyaluronic acid in Hepatitis C Virus Patients under antiviral therapy (time frame: 48 weeks). 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 28 Nov 2013.