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Vitamin D as an add-on Therapy With Pegylated Interferon and Ribavirin for Chronic Hepatitis c

NCT01655966 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2014-01-29

No results posted yet for this study

Summary

Chronic hepatitis C is endemic in Egypt with a high prevalence of the resistant genotype 4. Conventional standard of care treatment has modest response with only 50% sustained virologic response. Recent reports have suggested an augmented response with the addition of vitamin D. This is a prospective randomized trial to assess the effectiveness of adding vitamin D to standard of care for chronic hepatitis C genotype 4.

Conditions

  • Chronic Hepatitis c

Interventions

DRUG

vitamin D +pegylated interferon + ribavirin

Vitamin D: 1mcg once daily 48 weeks Pegylated interferon 160ug once weekly 48 weeks Ribavirin(\> 75kg:1200 mg, \<75kg:1000mg daily)48 weeks

DRUG

pegylated interferon + ribavirin

pegylated interferon 160ug once weekly Ribavirin (\> 75kg:1200 mg, \<75kg:1000mg daily)48 weeks

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Principal Investigators

  • Tamer Elbaz, MD · Cairo University

  • Hany Shehab, MD · Cairo University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2014-02-28
Completion
2014-04-30

Countries

  • Egypt

Study Locations

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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 NCT01655966 on ClinicalTrials.gov