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

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.

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02120274

Enrollment

Registered

2014-04-22

Start date

2014-03-31

Completion date

2016-05-31

Last updated

2016-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

RNA Virus Infections, Flaviviridae Infections, Hepatitis C, Hepatitis C, Chronic, Vitamin D, Cholecalciferol, Vitamin B 12

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.

Interventions

DRUGVitamin D

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

DRUGVitamin 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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

Design outcomes

Primary

Measure	Time frame	Description
SVR12	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

Measure	Time frame	Description
RVR, EVR, EOT	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);

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026