Vitamin D and Vitamin B12 Supplementation With Pegylated Interferon-Alfa Plus Ribavirin for Treating Chronic Hepatitis C
Primary Purpose
RNA Virus Infections, Flaviviridae Infections, Hepatitis C
Status
Terminated
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Vitamin D
Vitamin B 12
Sponsored by
About this trial
This is an interventional treatment trial for RNA Virus Infections focused on measuring RNA Virus Infections, Flaviviridae Infections, Hepatitis C, Hepatitis C, Chronic, Vitamin D, Cholecalciferol, Vitamin B 12
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Outpatient Clinic of Viral Hepatitis (NUPAIG)
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
Vitamins
Arm Description
Pegylated Interferon-Alfa plus ribavirin for 48 weeks
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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);
Full Information
NCT ID
NCT02120274
First Posted
April 18, 2014
Last Updated
August 23, 2016
Sponsor
Federal University of São Paulo
1. Study Identification
Unique Protocol Identification Number
NCT02120274
Brief Title
Vitamin D and Vitamin B12 Supplementation With Pegylated Interferon-Alfa Plus Ribavirin for Treating Chronic Hepatitis C
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.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Terminated
Why 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.
Study Start Date
March 2014 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of São Paulo
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
RNA Virus Infections, Flaviviridae Infections, Hepatitis C, Hepatitis C, Chronic
Keywords
RNA Virus Infections, Flaviviridae Infections, Hepatitis C, Hepatitis C, Chronic, Vitamin D, Cholecalciferol, Vitamin B 12
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
85 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
Pegylated Interferon-Alfa plus ribavirin for 48 weeks
Arm Title
Vitamins
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Vitamin D
Intervention Description
Oral vitamin D 2,000 IU qd throughout, irrespective of baseline vitamin D level.
Intervention Type
Drug
Intervention Name(s)
Vitamin B 12
Intervention Description
Intramuscular vitamin B12 5000 UI will be given weekly in the first 12 weeks followed by a monthly injection until the end of therapy.
Primary Outcome Measure Information:
Title
SVR12
Description
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.
Time Frame
12 weeks after treatment completion
Secondary Outcome Measure Information:
Title
RVR, EVR, EOT
Description
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);
Time Frame
week 4, week 12 and at the end-of-treatment.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adauto Castelo, PhD
Organizational Affiliation
Federal University of São Paulo
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Jorge F Senise, PhD
Organizational Affiliation
Federal University of São Paulo
Official's Role
Study Chair
Facility Information:
Facility Name
Outpatient Clinic of Viral Hepatitis (NUPAIG)
City
São Paulo
ZIP/Postal Code
04025-001
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
Vitamin D and Vitamin B12 Supplementation With Pegylated Interferon-Alfa Plus Ribavirin for Treating Chronic Hepatitis C
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