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

Federal University of São Paulo

Status and phase: Terminated; Phase 4

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

Treatments: Drug: Vitamin D; Drug: Vitamin B 12

Study type: Interventional

Funder types: Other

Identifiers

NCT02120274

U1111-1155-6986 (Other Identifier)

DB12SHCV

Details and patient eligibility

About

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.

Full 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.

Enrollment: 85 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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85 participants in 2 patient groups

Control

No Intervention group

Description:

Pegylated Interferon-Alfa plus ribavirin for 48 weeks

Vitamins

Experimental group

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.

Treatment:

Drug: Vitamin B 12

Drug: Vitamin D