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Add Vitamin D With Standard of Care for Chronic Hepatitis C Patients (Addwin)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01439776
Recruitment Status : Unknown
Verified September 2011 by Dae Won Jun, Hanyang University.
Recruitment status was:  Not yet recruiting
First Posted : September 23, 2011
Last Update Posted : September 23, 2011
Information provided by (Responsible Party):

Study Description
Brief Summary:
Standard therapy for chronic hepatitis C virus (HCV) is (Peg/RBV) combination therapy obtaining sustained virologic response (SVR) in 77% of naïve patients with genotype 1-3 Studies rarely address the issues of improving host factors. The current study examines whether adding vitamin D with Peg/RBV, a potent immunomodulator, could improve viral response(SVR)compared to Peg/RBV.

Condition or disease Intervention/treatment Phase
Chronic Hepatitis C Dietary Supplement: Vit D Phase 4

Detailed Description:
The working hypothesis is that Adding vitamin D to conventional Peg/RBV therapy for naïve, genotype 1-3 patients with chronic HCV infection significantly improves RVR, EVR additionally.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 222 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Multi-center, Phase IV Open-label Study Evaluating the Antiviral Efficacy of Addition of Vitamin D in Patients With Treatment Naïve Chronic Hepatitis C Receiving Peginterferon Alfa-2a Plus Ribavirin
Study Start Date : September 2011
Estimated Primary Completion Date : February 2013
Estimated Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
No Intervention: Peginterferon alfa 2a+Ribavirin
standard of care for HCV : peginterferon alfa 2a and ribavirin
Experimental: Vit D+Peginterferon alfa 2a+Ribavirin
VitD+Peginterferon alfa 2a+Ribavirin
Dietary Supplement: Vit D

Outcome Measures

Primary Outcome Measures :
  1. Number of participants with Sustained virologic response (SVR) [ Time Frame: 24w after completing Peg/RBV ]
    Compare the number of participants with HCV RNA is not detected in the blood at 24 weeks post-treatment between vitamin D and control group.

Secondary Outcome Measures :
  1. Number of participants with End of treatment response (ETR) [ Time Frame: 48 weeks at Genotype 1, 24 weeks at Genotye 2 and 3 ]

    Compare the number of participants with HCV RNA is not detected in the blood at the end of treatment between two groups.

    HCV RNA pCR perform at 48 weeks in genotye 1, at 24 weeks in Genotye 2 and 3

  2. Number of participants with Rapid virological response (RVR) [ Time Frame: Week 4 ]
    Compare the number of participants with HCV RNA is notdetectable in the blood at week 4 of treatment between vitamin and control group

  3. Number of participants with Early virological response (EVR) [ Time Frame: Week 12 ]
    Compare the number of participants with HCV RNA cannot be detected in the blood at week 12 of treatment between viatmin and control group

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Chronic genotype 1-3 HCV infection
  • Treatment Naive

Exclusion Criteria:

  • Child B and C
  • HCC patients
  • Pregnancy
Contacts and Locations

Information from the National Library of Medicine

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): NCT01439776

Contact: Daewon Jun, professor 82222909501 noshin@hanyang.ac.kr
Contact: Jungmin Cho, CRC 82222909501 01sin03@naver.com

Korea, Republic of
Soonchunhyang university Hospital Cheonan Not yet recruiting
Cheonan, Chungcheongnam-do, Korea, Republic of, 330721
Contact: Saehwan Lee, Professor       stevesh@schmc.ac.kr   
Principal Investigator: Saehwan Lee, Professor         
Soonchunhyang university hospital Bucheon Not yet recruiting
Bucheon, Gyeonggi-do, Korea, Republic of, 420767
Contact: Sanggyune Kim, professor       mcnulty@schbc.ac.kr   
Principal Investigator: Sanggyune Kim, professor         
HANYANG University Guri Hospital Not yet recruiting
Guri, Gyeonggido, Korea, Republic of, 471701
Contact: Joohyun Sohn, Professor       sonjh@hanyang.ac.kr   
Principal Investigator: Joohyun Sohn, Professor         
Bundang Jesaeng Hospital Not yet recruiting
Seongnam, Gyeonggido, Korea, Republic of, 463774
Contact: Bohyun Kim, M.D.       bohkim@medimail.co.kr   
Principal Investigator: Bohyun Kim, Kwajang         
Chuncheon Sacred Heart Hospital Not yet recruiting
Chuncheon, Kangwondo, Korea, Republic of, 200704
Contact: Kitae Suk, Professor       ktsuk@hallym.ac.kr   
Principal Investigator: Kitae Suk, Professor         
Wonju Christian Hospital Not yet recruiting
Wonju, Kangwondo, Korea, Republic of, 220-701
Contact: Munyeong Kim, Professor         
Principal Investigator: Munyeong Kim, Professor         
Kyong Hee University Medical Center Not yet recruiting
Seoul, Korea, Republic of, 130702
Contact: JaeJoon Shim, Professor       joyshim@khu.ac.kr   
Principal Investigator: JaeJoon Shim, Professor         
Hanyang University Seoul Hospital Not yet recruiting
Seoul, Korea, Republic of, 133792
Contact: Daewon Jun, Professor       noshin@hanyang.ac.kr   
Principal Investigator: Daewon Jun, Professor         
Kangdong Sacred Heart Hospital Not yet recruiting
Seoul, Korea, Republic of, 134701
Contact: Hyungsu Kim, Professor       hskim@hallym.or.kr   
Principal Investigator: Hyungsoo Kim, Professor         
Gangnam Severance Hospital Not yet recruiting
Seoul, Korea, Republic of, 135720
Contact: Jakyung Kim, Professor       ceciliak@yuhs.ac   
Principal Investigator: Jakyung Kim, Professor         
Sooncunhayng University Hospital Seoul Not yet recruiting
Seoul, Korea, Republic of, 140887
Contact: Soungwon Jeong, professor       jeongsw@hosp.sch.ac.kr   
Principal Investigator: Soungwon Jeong, Professor         
BORAMAE Medical Center Not yet recruiting
Seoul, Korea, Republic of, 156707
Contact: Won Kim, professor       drwon1@snu.ac.kr   
Principal Investigator: Won Kim, Professor         
Chungang University Hospital Not yet recruiting
Seoul, Korea, Republic of, 156861
Contact: Hyunwoong Lee, Professor       lhwdoc@hanmail.net   
Principal Investigator: Hyunwoong Lee, Professor         
Sponsors and Collaborators
Hanyang University
Roche Pharma AG
More Information

Responsible Party: Dae Won Jun, professor, Hanyang University
ClinicalTrials.gov Identifier: NCT01439776     History of Changes
Other Study ID Numbers: ML25569
First Posted: September 23, 2011    Key Record Dates
Last Update Posted: September 23, 2011
Last Verified: September 2011

Keywords provided by Dae Won Jun, Hanyang University:
chronic hepatitis C
Vit D
Peginterferon alfa 2a

Additional relevant MeSH terms:
Hepatitis A
Hepatitis C
Hepatitis, Chronic
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Vitamin D
Peginterferon alfa-2a
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Immunologic Factors