UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017150 |
|---|---|
| Receipt number | R000019894 |
| Scientific Title | The efficacy and safety of vitamin D supplementation for the treatment of NAFLD/NASH |
| Date of disclosure of the study information | 2015/04/17 |
| Last modified on | 2015/04/16 16:38:21 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
The efficacy and safety of vitamin D supplementation for the treatment of NAFLD/NASH
Acronym
The efficacy and safety of vitamin D supplementation for the treatment of NAFLD/NASH
Scientific Title
The efficacy and safety of vitamin D supplementation for the treatment of NAFLD/NASH
Scientific Title:Acronym
The efficacy and safety of vitamin D supplementation for the treatment of NAFLD/NASH
Region
| Japan |
Condition
Condition
NAFLD/NASH
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of vitamin D supplementation for NAFLD/NASH patients
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The liver function and the degree of liver fibrosis after vitamin D supplementation for 48weeks
Key secondary outcomes
1.The lipid and glycometabolism after vitamin D supplementation for 48weeks
2.The safety of vitamin D supplementation
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
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Taking alcohol less than 20g/day
2.NAFLD/NASH was diagnosed by liver biopsy
Key exclusion criteria
1.pregnant woman or lactating mother
2.poorly controlled heart failure
3.poorly controlled diabetes or hypertension
4.evere 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 C antibody, 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
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
atsukawa-nms@umin.ac.jp
Sponsor or person
Institute
Nippon Medical School Chiba Hokusoh Hospital
Institute
Department
Personal name
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
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
| 2015 | Year | 04 | Month | 17 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
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
Open public recruiting
Date of protocol fixation
| 2015 | Year | 04 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 04 | Month | 17 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 04 | Month | 16 | Day |
Last modified on
| 2015 | Year | 04 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019894
