UMIN-CTR Clinical Trial

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 Yoshiyuki Middle name Last name Yoshiyuki Ueno
Organization	Tohoku Univerisity Graduate School of Medicine
Division name	Div. Gastroenterology
Zip code	9808574
Address	1-1 Seiryo, Aobaku, Sendai
TEL	0227177171
Email	yueno@med.tohoku.ac.jp

Public contact
Name of contact person	1st name Yoshiyuki Middle name Last name Ueno
Organization	Tohoku Univerisity Graduate School of Medicine
Division name	Div. Gastroenterology
Zip code	9808574
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	IRB Tohoku University Graduate School of Medicine
Address	2-1 Seiryo, Aobaku, Sendai
Tel	0227177171
Email	hisyo3@med.tohoku.ac.jp

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	http://www.ncbi.nlm.nih.gov/pubmed/23717463
Publication of results	Unpublished

Result
URL related to results and publications	http://www.ncbi.nlm.nih.gov/pubmed/23717463
Number of participants that the trial has enrolled	10
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	2021 Year 03 Month 12 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	Chronic Hepatitis C
Participant flow	10 Patients were enrolled.
Adverse events	none except for already reported.
Outcome measures	sustained virological response (SVR24)
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	2010 Year 07 Month 01 Day
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	2021 Year 03 Month 12 Day

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