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

Sponsor

Federal University of São Paulo (Other)

Overall Status

Terminated

CT.gov ID

NCT02120274

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

3.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
RNA Virus Infections Flaviviridae Infections Hepatitis C Hepatitis C, Chronic	Drug: Vitamin D Drug: Vitamin B 12	Phase 4

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

Study Type:

Interventional

Actual Enrollment :

85 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Mar 1, 2014

Actual Primary Completion Date :

May 1, 2016

Actual Study Completion Date :

May 1, 2016

Arms and Interventions

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

Arm

Intervention/Treatment

No Intervention: Control

Pegylated Interferon-Alfa plus ribavirin for 48 weeks

Experimental: Vitamins

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

Oral vitamin D 2,000 IU qd throughout, irrespective of baseline vitamin D level.

Drug: Vitamin B 12

Intramuscular vitamin B12 5000 UI will be given weekly in the first 12 weeks followed by a monthly injection until the end of therapy.

Outcome Measures

Primary Outcome Measures

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

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);

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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