Chronic Hepatitis CNCT00804752
Vitamin D Treatment in Patients With Chronic Hepatitis C
A study testing Adding vitamin D and Vitamin D in people with Chronic Hepatitis C, run by Hillel Yaffe Medical Center at 1 site in Israel.
Trial summary
We hypothesize that patients with Ch.HCV have a low level of vitamin D, and that by raising their vitamin D levels by adding it to their standard treament of Pegylated Interferon and Ribavirin, there will be an increase in their sustained virological response. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Hepatitis C
- What is being tested?
- Adding vitamin D and Vitamin D
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteIsrael
- Study dates
- Start not givento not given
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic Hepatitis C Genotype 1
Who cannot join
- Vitamin D intoxication Renal Failure Liver Failure Malignancy
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Hillel Yaffe Medical Center
Hadera, 38100
Saif Abu-Mouch, MD, saif@hy.health.gov.il
Saif Abu-Mouch, MD
About this study
We hypothesize that patients with Ch.HCV have a low level of vitamin D, and that by raising their vitamin D levels by adding it to their standard treament of Pegylated Interferon and Ribavirin, there will be an increase in their sustained virological response.
- Conditions
- Chronic Hepatitis C
- Being tested
- Adding vitamin D, Vitamin D
- Keywords
- Patients with Chronic Hepatitis C
- Medical subject headings
- Hepatitis C, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adding vitamin DDrug
Adding 1000IU/Vitamin D daily
Vitamin DDrug
Addition of 1000IU/day Vitamin D
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D | Experimental | An addition of Vitamin D to the standard treatment Receives: Drug: Adding vitamin D; Drug: Vitamin D |
What is being measured
The primary outcome is the main question the study is designed to answer.
To increase the sustained virological response
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2008 (estimated)
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 N/A
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00804752
- Sponsor's protocol ID
- 0040-08-HYMC
- Status last verified
- Dec 2008
- First submitted
- 7 Dec 2008
- Last updated
- 9 Dec 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D Treatment in Patients With Chronic Hepatitis C
- ClinicalTrials.gov ID
- NCT00804752
- Acronym / sponsor ID
- 0040-08-HYMC
- Conditions
- Chronic Hepatitis C
- Keywords
- Patients with Chronic Hepatitis C
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- First posted
- 9 Dec 2008 (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.
We hypothesize that patients with Ch.HCV have a low level of vitamin D, and that by raising their vitamin D levels by adding it to their standard treament of Pegylated Interferon and Ribavirin, there will be an increase in their sustained virological response.
Study design
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vitamin D | Experimental | Drug: Adding vitamin D, Drug: Vitamin DAn addition of Vitamin D to the standard treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Chronic Hepatitis C Genotype 1
Key exclusion criteria (1 listed)
- Vitamin D intoxication Renal Failure Liver Failure Malignancy
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 |
|---|---|---|
| Adding vitamin DAdding 1000IU/Vitamin D daily | Drug | Vitamin D |
| Vitamin DAddition of 1000IU/day Vitamin D | Drug | Vitamin D |
Primary outcome
To increase the sustained virological response
Time frame: One year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2008.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adding vitamin D and Vitamin D in people with Chronic Hepatitis C, run by Hillel Yaffe Medical Center at 1 site in Israel.
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 1 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 9 Dec 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. 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.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To increase the sustained virological response (time frame: One year). 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 9 Dec 2008.