UMIN-CTR Clinical Trial

Basic information
Public title	Changes of resistance-associated variants in HCV NS5A region post vitamin D supplementation for patients with chronic hepatitis C
Acronym	Efficacy of vitamin D supplementation for resistance-associated variants in NS5A region
Scientific Title	Changes of resistance-associated variants in HCV NS5A region post vitamin D supplementation for patients with chronic hepatitis C
Scientific Title:Acronym	Efficacy of vitamin D supplementation for resistance-associated variants in NS5A region
Region	Japan

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

Objectives
Narrative objectives1	To reveal the effect of vitamin D supplementation to the prevalence of resistance-associated variants in NS5A region.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	The concentration of serum 25(OH)D3 after 16 weeks supplementation of vitamin D, and the prevalence of resistance-associated variants in NS5A region
Key secondary outcomes	The changes in laboratory tests associated with liver function and fibrosis after 16 weeks supplementation of vitamin D.

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	Food
Interventions/Control_1	Patients were treated with vitamin D supplementation (2000IU/day, once daily, after breakfast)for 16 weeks.
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	18 years-old <=
Age-upper limit	80 years-old >
Gender	Male and Female
Key inclusion criteria	Chronic hepatitis C patients with resistance-associated variants in HCV NS5A region.
Key exclusion criteria	1. pregnant woman or lactating mother 2. poorly controlled heart failure 3. poorly controlled diabetes or hypertension 4. severe renal disorder 5. decompensated liver cirrhosis 6. other liver diseases, including autoimmune hepatitis, primary biliary cirrhosis and alcoholic hepatitis, liver failure 7. positive result for hepatitis B surface antigen and antibody to human immunodeficiency virus type-1 8. hypercarcemia 9. hyperparathyroidism 10. medication with other vitamin preparations 11. Judged by investigator not to be appropriate for inclusion in this study
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Middle name Last name Masanori Atsukawa
Organization	Nippon Medical School Chiba Hokusoh Hospital
Division name	Division of Gastroenterology
Zip code
Address	1715,Kamakari,Inzai,Chiba, 270-1694, Japan
TEL	0476-99-1111
Email	atsukawa-nms@umin.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Masanori Atsukawa
Organization	Nippon Medical School Chiba Hokusoh Hospital
Division name	Division of Gastroenterology
Zip code
Address	1715,Kamakari,Inzai,Chiba, 270-1694, Japan
TEL	0476-99-1111
Homepage URL
Email	atsukawa-nms@umin.ac.jp

Sponsor
Institute	Nippon Medical School Chiba Hokusoh Hospital
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	None

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	日本医科大学千葉北総病院(千葉県)/ Nippon Medical School Chiba Hokusoh Hospital(Chiba)

Other administrative information
Date of disclosure of the study information	2015 Year 07 Month 29 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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	2015 Year 07 Month 22 Day
Date of IRB	2015 Year 07 Month 22 Day
Anticipated trial start date	2015 Year 07 Month 29 Day
Last follow-up date	2020 Year 03 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2020 Year 03 Month 30 Day

Other
Other related information

Management information
Registered date	2015 Year 07 Month 28 Day
Last modified on	2020 Year 04 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021374