Hepatitis C Clinical Trial
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.
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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