UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021876 |
|---|---|
| Receipt number | R000025223 |
| Scientific Title | The safety and efficacy of a fish oil based fat emulsion in the treatment of parenteral nutrition associated liver disease |
| Date of disclosure of the study information | 2016/04/18 |
| Last modified on | 2023/04/19 17:16:54 |
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Basic information
Public title
The safety and efficacy of a fish oil based fat emulsion in the treatment of parenteral nutrition associated liver disease
Acronym
The safety and efficacy of a fish oil based fat emulsion in the treatment of parenteral nutrition associated liver disease
Scientific Title
The safety and efficacy of a fish oil based fat emulsion in the treatment of parenteral nutrition associated liver disease
Scientific Title:Acronym
The safety and efficacy of a fish oil based fat emulsion in the treatment of parenteral nutrition associated liver disease
Region
| Japan |
Condition
Condition
parenteral nutrition associated liver disease
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and efficacy of a fish oil based fat emulsion in the treatment of parenteral nutrition associated liver disease.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Direct bilirubin
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
period:8weeks
frequency:6days/week
dose:0.5 to 1.5g/kg/day
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
| 2 | weeks-old | <= |
Age-upper limit
| 1 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Direct bilirubin>2.0mg/dl continues more than two weeks
Key exclusion criteria
Liver disease caused by other illness
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | Motoshi |
| Middle name | |
| Last name | Wada |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Pediatric Surgery
Zip code
9808574
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, Japan
TEL
022-717-7237
wada@ped-surg.med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Megumi |
| Middle name | |
| Last name | Nakamura |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Pediatric Surgery
Zip code
9808574
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, Japan
TEL
022-717-7237
Homepage URL
nakamuu.11-03@ped-surg.med.tohoku.ac.jp
Sponsor or person
Institute
Self procurance
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tohoku University Graduate School of Medicine
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, Japan
Tel
022-717-7237
wada@ped-surg.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
| 2016 | Year | 04 | Month | 18 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-open-bin/icdr/ctr_view.cgi?recptno=R000025223
Publication of results
Unpublished
Result
URL related to results and publications
https://center6.umin.ac.jp/cgi-open-bin/icdr/ctr_view.cgi?recptno=R000025223
Number of participants that the trial has enrolled
4
Results
During the research period, four cases with liver dysfunction accompanied by cholestasis were treated with Omegaven, resulting in improvement of liver dysfunction. All cases survived and were discharged.
Results date posted
| 2023 | Year | 04 | Month | 19 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
two cases of low birth weight infants with meconium-related intestinal obstruction who underwent ileocecal stoma construction
one case of intestinal obstruction due to jejunal atresia
one case of jejunal stoma construction due to small intestinal perforation
Participant flow
All four cases developed liver dysfunction with cholestasis. According to the protocol, they were treated with Omegaven for 67, 45, 24, and 68 days, respectively, and the liver dysfunction improved. All cases survived and were discharged, and are currently under outpatient follow-up.
Adverse events
One case developed enteritis judged to have no causal relationship with the drug.
Outcome measures
liver dysfunction with cholestasis
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 04 | Month | 18 | Day |
Date of IRB
| 2016 | Year | 03 | Month | 22 | Day |
Anticipated trial start date
| 2016 | Year | 04 | Month | 18 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 04 | Month | 11 | Day |
Last modified on
| 2023 | Year | 04 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025223
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
