|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
JPRN |
|
Last refreshed on:
|
17 October 2023 |
|
Main ID: |
JPRN-jRCTs041180088 |
|
Date of registration:
|
12/03/2019 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Influence of fatty acid metabolism for clinical course of biliary atresia
|
|
Scientific title:
|
The difference of the profile of fatty acids and eicosanoids in clinical course and the effect to the prognosis by collection of biliary atresia |
|
Date of first enrolment:
|
01/12/2016 |
|
Target sample size:
|
30 |
|
Recruitment status: |
Complete |
|
URL:
|
https://jrct.niph.go.jp/latest-detail/jRCTs041180088 |
|
Study type:
|
Interventional |
|
Study design:
|
non-randomized controlled trial, open(masking not used), active control, parallel assignment, treatment purpose
|
|
Phase:
|
N/A
|
|
|
Contacts
|
|
Name:
|
Wataru
Sumida |
|
Address:
|
Aichi
466-8550
Aichi
Japan |
|
Telephone:
|
+81-52-744-2959 |
|
Email:
|
wsumida@med.nagoya-u.ac.jp |
|
Affiliation:
|
Nagoya University Hospital |
|
|
Name:
|
Wataru
Sumida |
|
Address:
|
Aichi
466-8550
Aichi
Japan |
|
Telephone:
|
+81-52-744-2959 |
|
Email:
|
wsumida@med.nagoya-u.ac.jp |
|
Affiliation:
|
Nagoya University Hospital |
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria: 1) New case with biliary atresia. 2) As control group A, cases of suspected biliary atresia with liver dysfunction or jaundice. 3) As control group B, healthy individuals with similar age.
Exclusion criteria: A history of blood transfusion within 1 month before enrollment
Age minimum:
Not applicable
Age maximum:
Not applicable
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
biliary atresia, neonatal hepatitis, Alagille syndrome, PFIC, etc.
|
|
Intervention(s)
|
|
oral administration of 30(+/- 10)mg/kg/day of eicosapentaenoic acid
|
|
Primary Outcome(s)
|
|
Liver fibrosis in BA patients with or without administration of EPA
|
|
Secondary Outcome(s)
|
|
The difference of concentration of long chain polyunsaturated fatty acids, or eicosanoids among BA group and non-BA groups
|
|
Source(s) of Monetary Support
|
|
Ethics review
|
Status: Approval
Approval date:
Contact:
ethics@med.nagoya-u.ac.jp
Nagoya University Certified Review Board
+81-52-744-2479
ethics@med.nagoya-u.ac.jp
|
|
Results
|
|
Results available:
|
Yes |
|
Date Posted:
|
02/03/2022 |
|
Date Completed:
|
17/01/2022 |
|
URL:
|
|
|
|