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

NCT02120274 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 85

Last updated 2016-08-24

No results posted yet for this study

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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • Federal University of São Paulo

    lead OTHER

Principal Investigators

  • Adauto Castelo, PhD · Federal University of São Paulo

  • Jorge F Senise, PhD · Federal University of São Paulo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2016-05-31
Completion
2016-05-31

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02120274 on ClinicalTrials.gov