UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015513 |
|---|---|
| Receipt number | R000018022 |
| Scientific Title | Efficacy and safety assessment of retinol palmitate (Vitamin A) for acute brain infarction, phaseI and multi-center, randomized controlled, phaseII trial. |
| Date of disclosure of the study information | 2014/10/23 |
| Last modified on | 2014/10/23 15:05:41 |
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Basic information
Public title
Efficacy and safety assessment of retinol palmitate (Vitamin A) for acute brain infarction, phaseI and multi-center, randomized controlled, phaseII trial.
Acronym
Efficacy and safety assessment of retinol palmitate (Vitamin A) for acute brain infarction, phaseI and multi-center, randomized controlled, phaseII trial.
Scientific Title
Efficacy and safety assessment of retinol palmitate (Vitamin A) for acute brain infarction, phaseI and multi-center, randomized controlled, phaseII trial.
Scientific Title:Acronym
Efficacy and safety assessment of retinol palmitate (Vitamin A) for acute brain infarction, phaseI and multi-center, randomized controlled, phaseII trial.
Region
| Japan |
Condition
Condition
Brain infarction
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Efficacy and safety assessment of retinol palmitate (Vitamin A) for acute brain infarction patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase I,II
Assessment
Primary outcomes
The ratio of equal or more than 3 points improvement of NIHSS on 30+/-4days after treatment compared with admission.
Key secondary outcomes
1)mRS on discharge
2)NIHSS on 7+/-1days after admission, NIHSS compared with admission.
3)NIHSS/mRS on 30+/-4days after admission, NIHSS/mRS compared with admission.
4)NIHSS/mRS on 90+/-7days after admission, NIHSS/mRS compared with admission.
5)Dimention of ischemic lesion on MRI FLAIR imaging on 90+/-7days after admission.
6)Episode of delirium on 1day, 2days, 3days, 4days and 7days after admission
7)Other adverse events
Base
Study type
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Group with taking retinol palmitate
Interventions/Control_2
Group without taking retinol palmitate
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Acute brain infarction patients who visit hospital within 24 hours after symptom oncet and whose NIHSS is between 3 and 15 points.
2)Patients with consent of this study in writing which obtained from patients or legal representative.
Key exclusion criteria
1)Patients with pregnancy.
2)Patinents who take Vitamin A derivative (Etretinate/ tretinoin/ tamibarotene).
3)Patients with serious organ damage.
4)Patients who are considered inappropriate to participate in the study by principal investigator.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Satoshi Kuwabara, Masahiro Mori |
Organization
Graduate School of Medicine, Chiba University
Division name
Department of Neurology
Zip code
Address
1-8-1, Inohana, Chouo-ward, Chiba-city, Chiba-prefecture, Japan
TEL
043-226-2126
morim@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Jun-ichiro Shimada |
Organization
Chiba Cardiovascular Center
Division name
Department of Neurology
Zip code
Address
575, Turumai, Ichihara-city, Chiba-prefecture, Japan
TEL
0436-88-3111
Homepage URL
j-shimada@chiba-u.jp
Sponsor or person
Institute
Department of Neurology , Graduate School of Medicine, Chiba University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Chiba University Hospital Clinical Research Center, Chiba Cardiovascular Center
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
千葉大学医学部付属病院神経内科、千葉県循環器病センター脳卒中診療部
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 10 | Month | 23 | 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
| 2013 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 01 | Month | 01 | 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
| 2014 | Year | 10 | Month | 23 | Day |
Last modified on
| 2014 | Year | 10 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018022
