Vitamin D and Vitamin B12 Supplementation With Pegylated Interferon-Alfa Plus Ribavirin for Treating Chronic Hepatitis C
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|ClinicalTrials.gov Identifier: NCT02120274|
Recruitment Status : Terminated (New Brazilian Guidelines for Viral Hepatitis C and Coinfetions. It does not include the treatment of chronic HCV Metavir < F3 and abandon the use of interferon.)
First Posted : April 22, 2014
Last Update Posted : August 24, 2016
|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|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||85 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 :||March 2014|
|Actual Primary Completion Date :||May 2016|
|Actual Study Completion Date :||May 2016|
No Intervention: Control
Pegylated Interferon-Alfa plus ribavirin for 48 weeks
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.
- 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.
- RVR, EVR, EOT [ Time Frame: 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);
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02120274
|Outpatient Clinic of Viral Hepatitis (NUPAIG)|
|São Paulo, Brazil, 04025-001|
|Study Director:||Adauto Castelo, PhD||Federal University of São Paulo|
|Study Chair:||Jorge F Senise, PhD||Federal University of São Paulo|