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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003694
Receipt No. R000004474
Scientific Title Effect of Vitamine D3 for the patients whith chronic hepatitis C who recieved PEG-interferon alpha plus ribavirin: possible applicaition for database establishment.
Date of disclosure of the study information 2010/06/10
Last modified on 2017/09/11

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Basic information
Public title Effect of Vitamine D3 for the patients whith chronic hepatitis C who recieved PEG-interferon alpha plus ribavirin: possible applicaition for database establishment.
Acronym EVIDENCE study
Scientific Title Effect of Vitamine D3 for the patients whith chronic hepatitis C who recieved PEG-interferon alpha plus ribavirin: possible applicaition for database establishment.
Scientific Title:Acronym EVIDENCE study
Region
Japan

Condition
Condition chronic hepatitis C
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 Effects of Vitamine D3 during PEG-interferon alpha plus ribavirin treatment.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Sustained viral response (SVR)
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Vitamine D3, PEG-interferon alpha and ribavirin
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with chronic hepatits C complicating with osteoporosis.
Key exclusion criteria Any contraindication for (PEG) interferon, ribavirin, and Vitamine D3 suppliments.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshiyuki Ueno
Organization Tohoku Univerisity Graduate School of Medicine
Division name Div. Gastroenterology
Zip code
Address 1-1 Seiryo, Aobaku, Sendai, Japan
TEL 022-717-7171
Email yoshiyuueno-gi@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshiyuki Ueno
Organization Tohoku Univerisity Graduate School of Medicine
Division name Div. Gastroenterology
Zip code
Address 1-1 Seiryo, Aobaku, Sendai
TEL 022-717-7171
Homepage URL
Email yoshiyuueno-gi@umin.ac.jp

Sponsor
Institute Division of Gastroenterology, Tohoku Univerisity Graduate School of Medicine
Institute
Department

Funding Source
Organization Industry based non-specific funding
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2010 Year 06 Month 10 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.ncbi.nlm.nih.gov/pubmed/23717463
Number of participants that the trial has enrolled
Results 1(OH) vitamin D3 could improve the sensitivity of Peg-IFN/RBV therapy on HCV-infected hepatocytes by reducing the IP-10 production from PBMCs and ISGs expression in the liver.
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2010 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2010 Year 06 Month 01 Day
Last follow-up date
2013 Year 07 Month 01 Day
Date of closure to data entry
2014 Year 12 Month 31 Day
Date trial data considered complete
2015 Year 03 Month 31 Day
Date analysis concluded
2015 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2010 Year 06 Month 02 Day
Last modified on
2017 Year 09 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004474

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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