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

NCT ID: NCT02120274

Last Updated: 2016-08-24

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 85 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2016-05-31

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.

Conditions

RNA Virus Infections; Flaviviridae Infections; Hepatitis C; Hepatitis C, Chronic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control

Pegylated Interferon-Alfa plus ribavirin for 48 weeks

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Vitamin D

Intervention Type: DRUG

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

Vitamin B 12

Intervention Type: DRUG

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

Interventions

Vitamin D

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

Intervention Type: 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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Federal University of São Paulo

OTHER

Sponsor Role: lead

Responsible Party

Henrique Pott Junior

Dr. Henrique Pott-Junior

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Adauto Castelo, PhD

Role: STUDY_DIRECTOR

Federal University of São Paulo

Jorge F Senise, PhD

Role: STUDY_CHAIR

Federal University of São Paulo

Locations

Outpatient Clinic of Viral Hepatitis (NUPAIG)

São Paulo, São Paulo, Brazil

Countries

Brazil

Other Identifiers

U1111-1155-6986

Identifier Type: OTHER

Identifier Source: secondary_id

DB12SHCV

Identifier Type: -

Identifier Source: org_study_id