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

Phase 4

Terminated

• Conditions: RNA Virus Infections; Flaviviridae Infections; Hepatitis C; Hepatitis C, Chronic
• Interventions: Drug: Vitamin D; Drug: Vitamin B 12

• Registration Number: NCT02120274
• Lead Sponsor: Federal University of São Paulo

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.

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-04-18
• Study First Submitted QC: 2014-04-21
• Study First Posted: 2014-04-22
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-23
• Last Update Posted: 2016-08-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 85

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vitamins	Vitamin D	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.
Vitamins	Vitamin B 12	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.

Primary Outcome Measures

Name	Time	Method
SVR12	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.

Secondary Outcome Measures

Name	Time	Method
RVR, EVR, EOT	week 4, week 12 and at the end-of-treatment.	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);

Trial Locations

Locations (1)

Outpatient Clinic of Viral Hepatitis (NUPAIG); 🇧🇷 São Paulo, Brazil