Vitamin D and Vitamin B12 Supplementation With Pegylated Interferon-Alfa Plus Ribavirin for Treating Chronic Hepatitis C

Study Overview
=================
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.

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.

Conditions
-----------------
Hepatitis C, Hepatitis C, Chronic, RNA Virus Infections, Flaviviridae Infections

Intervention / Treatment
-----------------
* Drug: Vitamin D
* Drug: Vitamin B 12


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Pegylated Interferon-Alfa plus ribavirin for 48 weeks | |
| Experimental: Vitamins<br>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. | Drug: Vitamin D<br>* Oral vitamin D 2,000 IU qd throughout, irrespective of baseline vitamin D level.<br>Drug: Vitamin B 12<br>* Intramuscular vitamin B12 5000 UI will be given weekly in the first 12 weeks followed by a monthly injection until the end of therapy.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 12 weeks after treatment completion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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); | week 4, week 12 and at the end-of-treatment. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
RNA Virus Infections, Flaviviridae Infections, Hepatitis C, Hepatitis C, Chronic, Vitamin D, Cholecalciferol, Vitamin B 12