Unique ID issued by UMIN | UMIN000018454 |
---|---|
Receipt number | R000021374 |
Scientific Title | Changes of resistance-associated variants in HCV NS5A region post vitamin D supplementation for patients with chronic hepatitis C |
Date of disclosure of the study information | 2015/07/29 |
Last modified on | 2020/04/29 07:29:24 |
Changes of resistance-associated variants in HCV NS5A region post vitamin D supplementation for patients with chronic hepatitis C
Efficacy of vitamin D supplementation for resistance-associated variants in NS5A region
Changes of resistance-associated variants in HCV NS5A region post vitamin D supplementation for patients with chronic hepatitis C
Efficacy of vitamin D supplementation for resistance-associated variants in NS5A region
Japan |
Chronic hepatitis C
Hepato-biliary-pancreatic medicine | Adult |
Others
YES
To reveal the effect of vitamin D supplementation to the prevalence of resistance-associated variants in NS5A region.
Safety,Efficacy
Exploratory
Pragmatic
Not applicable
The concentration of serum 25(OH)D3 after 16 weeks supplementation of vitamin D, and the prevalence of resistance-associated variants in NS5A region
The changes in laboratory tests associated with liver function and fibrosis after 16 weeks supplementation of vitamin D.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Food |
Patients were treated with vitamin D supplementation (2000IU/day, once daily, after breakfast)for 16 weeks.
18 | years-old | <= |
80 | years-old | > |
Male and Female
Chronic hepatitis C patients with resistance-associated variants in HCV NS5A region.
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
30
1st name | |
Middle name | |
Last name | Masanori Atsukawa |
Nippon Medical School Chiba Hokusoh Hospital
Division of Gastroenterology
1715,Kamakari,Inzai,Chiba, 270-1694, Japan
0476-99-1111
atsukawa-nms@umin.ac.jp
1st name | |
Middle name | |
Last name | Masanori Atsukawa |
Nippon Medical School Chiba Hokusoh Hospital
Division of Gastroenterology
1715,Kamakari,Inzai,Chiba, 270-1694, Japan
0476-99-1111
atsukawa-nms@umin.ac.jp
Nippon Medical School Chiba Hokusoh Hospital
None
Self funding
None
NO
日本医科大学千葉北総病院(千葉県)/ Nippon Medical School Chiba Hokusoh Hospital(Chiba)
2015 | Year | 07 | Month | 29 | Day |
Published
Completed
2015 | Year | 07 | Month | 22 | Day |
2015 | Year | 07 | Month | 22 | Day |
2015 | Year | 07 | Month | 29 | Day |
2020 | Year | 03 | Month | 30 | Day |
2020 | Year | 03 | Month | 30 | Day |
2015 | Year | 07 | Month | 28 | Day |
2020 | Year | 04 | Month | 29 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021374
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |