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.
Overview
- Phase
- Phase 4
- Intervention
- Vitamin D
- Conditions
- RNA Virus Infections
- Sponsor
- Federal University of São Paulo
- Enrollment
- 85
- Locations
- 1
- Primary Endpoint
- SVR12
- Status
- Terminated
- Last Updated
- 9 years ago
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.
Investigators
Henrique Pott Junior
Dr. Henrique Pott-Junior
Federal University of São Paulo
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
Arms & Interventions
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.
Intervention: Vitamin D
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.
Intervention: Vitamin B 12
Outcomes
Primary Outcomes
SVR12
Time Frame: 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 Outcomes
- RVR, EVR, EOT(week 4, week 12 and at the end-of-treatment.)