RNA Virus InfectionsPhase 4NCT02120274
Vitamin D and Vitamin B12 Supplementation With Pegylated Interferon-Alfa Plus Ribavirin for Treating Chronic Hepatitis C
A Phase 4 study testing Vitamin D and Vitamin B 12 in people with RNA Virus Infections and Flaviviridae Infections, run by Federal University of São Paulo at 1 site in Brazil.
Trial summary
The purpose of this study is to evaluate the effectiveness of the supplementation of vitamins D and B12 in combination with Pegylated Interferon-Alfa and Ribavirin in the treatment of genotype 1 chronic hepatitis C, who do not qualify to receive protease inhibitor in Brazil. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- RNA Virus Infections, Flaviviridae Infections, Hepatitis C
- What is being tested?
- Vitamin D and Vitamin B 12
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2014to May 2016
- Phase
- Phase 4
- 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
Who may be able to join
- Genotype 1 HCV infection confirmed a positive test for anti-HCV antibody and detectable serum HCV RNA by PCR
- Pegylated Interferon-Alfa treatment naïve
- Liver biopsy with Metavir F2 or less
- Cognitive capacity to understand and sign the informed consent
Who cannot join
- HBV or HIV co-infection
- Hemoglobin level less than 10 g/dL or total neutrophil count less than 1,500/mm3 or platlet count below 75,000/mm3
- Creatinin ≥ 1.5 mg/dL
- Severe cardiopathy
- Pregnancy or impossibility to use birth control methods by the couple, or breast-feeding
- Conditions that, according to the investigator's judgement, preclude participation in the study, including clinical, cognitive or behavioural conditions
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Outpatient Clinic of Viral Hepatitis (NUPAIG)
São Paulo, São Paulo, 04025-001
About this study
Official title: Randomized Clinical Trial to Assess the Effectiveness of Vitamin D and Vitamin B12 Supplementation in Combination With Pegylated Interferon-Alfa Plus Ribavirin for Treating Chronic Hepatitis C.
The purpose of this study is to evaluate the effectiveness of the supplementation of vitamins D and B12 in combination with Pegylated Interferon-Alfa and Ribavirin in the treatment of genotype 1 chronic hepatitis C, who do not qualify to receive protease inhibitor in Brazil.
Read the detailed description
Randomized clinical trial comparing rates of RVR, eRVR, EOT and SVR during standard treatment with Pegylated Interferon-Alfa plus Ribavirin compared to the same treatment supplemented with B12 and vitamin D during the treatment period.
Patients assigned to the vitamin supplementation group will receive the standard treatment of Pegylated Interferon-Alfa plus Ribavirin for 48 weeks together oral Vitamin D and intramuscular Vitamin B12. The control group will receive the same regimen of peguilated alfainterferon plus ribavirin for 48 weeks without any vitamin supplementation.
- Being tested
- Vitamin D, Vitamin B 12
- Keywords
- RNA Virus Infections, Flaviviridae Infections, Hepatitis C, Hepatitis C, Chronic, Vitamin D, Cholecalciferol, Vitamin B 12
- Medical subject headings
- RNA Virus Infections, Flaviviridae Infections, Hepatitis C, Hepatitis C, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin DDrug
Oral vitamin D 2,000 IU qd throughout, irrespective of baseline vitamin D level.
Vitamin B 12Drug
Intramuscular vitamin B12 5000 UI will be given weekly in the first 12 weeks followed by a monthly injection until the end of therapy.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Pegylated Interferon-Alfa plus ribavirin for 48 weeks |
| Vitamins | Experimental | Pegylated Interferon-Alfa plus ribavirin for 48 weeks together oral vitamin D 2,000 IU qd throughout, irrespective of baseline vitamin D level. Intramuscular vitamin B12 5000 UI will be given weekly in the first 12 weeks followed by a monthly injection until the end of therapy. Receives: Drug: Vitamin D; Drug: Vitamin B 12 |
What is being measured
The primary outcome is the main question the study is designed to answer.
SVR12
Proportion of patients with SVR, defined as HCV RNA bellow the limit of detection 12 weeks after treatment completion with peguilated alfainterferon-2B plus ribavirin, with or without vitamin supplementation.
Measured: 12 weeks after treatment completion
Secondary outcomes (1)
RVR, EVR, EOT
Proportion of patients presenting HCV RNA bellow the limit of detection at week 4 (RVR), week 12 (EVR - early virological response) and at the end-of-treatment (EOT);
Measured: week 4, week 12 and at the end-of-treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2014 (estimated)
- Study startMar 2014
- Primary completionMay 2016
- Study completionMay 2016
Why it stopped: New Brazilian Guidelines for Viral Hepatitis C and Coinfetions. It does not include the treatment of chronic HCV Metavir \< F3 and abandon the use of interferon.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RNA Virus InfectionsStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Henrique Pott Junior, Federal University of São Paulo
- Investigators
- Adauto Castelo, PhD, Study director, Federal University of São PauloJorge F Senise, PhD, Study chair, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02120274
- Sponsor's protocol ID
- DB12SHCV
- Other IDs
- U1111-1155-6986
- Status last verified
- Aug 2016
- First submitted
- 18 Apr 2014
- Last updated
- 24 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial to Assess the Effectiveness of Vitamin D and Vitamin B12 Supplementation in Combination With Pegylated Interferon-Alfa Plus Ribavirin for Treating Chronic Hepatitis C.
- ClinicalTrials.gov ID
- NCT02120274
- Acronym / sponsor ID
- DB12SHCV
- Keywords
- RNA Virus Infections, Flaviviridae Infections, Hepatitis C, Hepatitis C, Chronic, Vitamin D, Cholecalciferol, Vitamin B 12
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: New Brazilian Guidelines for Viral Hepatitis C and Coinfetions. It does not include the treatment of chronic HCV Metavir \< F3 and abandon the use of interferon.
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 22 Apr 2014 (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.
The purpose of this study is to evaluate the effectiveness of the supplementation of vitamins D and B12 in combination with Pegylated Interferon-Alfa and Ribavirin in the treatment of genotype 1 chronic hepatitis C, who do not qualify to receive protease inhibitor in Brazil.
Detailed description
Randomized clinical trial comparing rates of RVR, eRVR, EOT and SVR during standard treatment with Pegylated Interferon-Alfa plus Ribavirin compared to the same treatment supplemented with B12 and vitamin D during the treatment period.
Patients assigned to the vitamin supplementation group will receive the standard treatment of Pegylated Interferon-Alfa plus Ribavirin for 48 weeks together oral Vitamin D and intramuscular Vitamin B12. The control group will receive the same regimen of peguilated alfainterferon plus ribavirin for 48 weeks without any vitamin supplementation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Pegylated Interferon-Alfa plus ribavirin for 48 weeks |
| Vitamins | Experimental | Drug: Vitamin D, Drug: Vitamin B 12Pegylated Interferon-Alfa plus ribavirin for 48 weeks together oral vitamin D 2,000 IU qd throughout, irrespective of baseline vitamin D level. Intramuscular vitamin B12 5000 UI will be given weekly in the first 12 weeks followed by a monthly injection until the end of therapy. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Genotype 1 HCV infection confirmed a positive test for anti-HCV antibody and detectable serum HCV RNA by PCR
- Pegylated Interferon-Alfa treatment naïve
- Liver biopsy with Metavir F2 or less
- Cognitive capacity to understand and sign the informed consent
Key exclusion criteria (6 listed)
- HBV or HIV co-infection
- Hemoglobin level less than 10 g/dL or total neutrophil count less than 1,500/mm3 or platlet count below 75,000/mm3
- Creatinin ≥ 1.5 mg/dL
- Severe cardiopathy
- Pregnancy or impossibility to use birth control methods by the couple, or breast-feeding
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 DOral vitamin D 2,000 IU qd throughout, irrespective of baseline vitamin D level. | Drug | Vitamins |
| Vitamin B 12Intramuscular vitamin B12 5000 UI will be given weekly in the first 12 weeks followed by a monthly injection until the end of therapy. | Drug | Vitamins |
Primary outcome
SVR12
Time frame: 12 weeks after treatment completion
Proportion of patients with SVR, defined as HCV RNA bellow the limit of detection 12 weeks after treatment completion with peguilated alfainterferon-2B plus ribavirin, with or without vitamin supplementation.
1 secondary outcome
RVR, EVR, EOT
Time frame: week 4, week 12 and at the end-of-treatment.
Results and safety
The study was stopped early (reason given: New Brazilian Guidelines for Viral Hepatitis C and Coinfetions. It does not include the treatment of chronic HCV Metavir \< F3 and abandon the use of interferon.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2016.
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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.
Adauto Castelo, PhD study director
Federal University of São Paulo
Jorge F Senise, PhD study chair
Federal University of São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vitamin D and Vitamin B 12 in people with RNA Virus Infections and Flaviviridae Infections, run by Federal University of São Paulo at 1 site in Brazil.
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 4 inclusion and 6 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 24 Aug 2016. 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 Brazil. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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: New Brazilian Guidelines for Viral Hepatitis C and Coinfetions. It does not include the treatment of chronic HCV Metavir \< F3 and abandon the use of interferon.). 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?
SVR12 (time frame: 12 weeks after treatment completion). 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 24 Aug 2016; AzTrials last refreshed its copy on 8 Nov 2026.