UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037134 |
|---|---|
| Receipt number | R000042179 |
| Scientific Title | Intravenous immunoglobulin therapy combined with Vitamins E and C for Kawasaki Disease |
| Date of disclosure of the study information | 2019/06/24 |
| Last modified on | 2022/02/26 23:27:00 |
* 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
Intravenous immunoglobulin therapy combined with Vitamins E and C for Kawasaki Disease
Acronym
VITAMEC study
Scientific Title
Intravenous immunoglobulin therapy combined with Vitamins E and C for Kawasaki Disease
Scientific Title:Acronym
VITAMEC study
Region
| Japan |
Condition
Condition
Kawasaki disease
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether the combination of vitamin E and C with the standard treatment of Kawasaki disease, which have antioxidative activity, is the more effective treatment than the standard treatment
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The time from the start of treatment to fever reduction
Key secondary outcomes
Hospitalization period, CRP after treatment, Ratio of refractory cases, Ratio of relapsed cases, Complication rate of coronary artery lesion(during hospitalization, 1 month after onset), change of Z-score, change of LOX-1 ligand(before treatment, after fever reduction, 1 month after onset)
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 1 | years-old | <= |
Age-upper limit
| 6 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Untreated Kawasaki disease patients
2. Cases with fever higher than 37.5 degrees at entry
3. Cases in which agreement before entry are obtained the parents / legal representative after explanation of the clinical trial in details
Key exclusion criteria
1. Cases after the 9th disease day
2. Cases who is taking vitamins at the onset of Kawasaki disease
3. Cases who have coronaly artery lesion at entry
4. Recurrent or relapsed cases of Kawasaki disease
5. Cases whose cause of fever is other than Kawasaki disease
6. Cases who received immunoglobulin within 90 days before entry
7. Cases with serious underlying diseases
8. Cases taking immunosuppressive drugs such as steroids
9. Cases with other diseases that require oral administration of anticoagulants and antiplatelets
10. Cases with allergies to vitamins
11. Other cases judged by the investigator as inappropriate
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Toshiro |
| Middle name | |
| Last name | Hara |
Organization
Fukuoka Children's Hospital
Division name
Kawasaki disease center
Zip code
813-0017
Address
5-1-1, Kashiiteriha,Higashi-ku, Fukuoka-shi, Fukuoka
TEL
092-682-7000
hara.t@fcho.jp
Public contact
Name of contact person
| 1st name | Yumi |
| Middle name | |
| Last name | Mizuno |
Organization
Fukuoka Children's Hospital
Division name
Kawasaki disease center
Zip code
813-0017
Address
5-1-1, Kashiiteriha,Higashi-ku, Fukuoka-shi, Fukuoka
TEL
092-682-7000
Homepage URL
mizuno.y@fcho.jp
Sponsor or person
Institute
Fukuoka Children's Hospital
Kawasaki disease center
Institute
Department
Personal name
Funding Source
Organization
Fukuoka Children's Hospital
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fukuoka Children's Hospital
Address
5-1-1, Kashiiteriha,Higashi-ku, Fukuoka-shi, Fukuoka
Tel
092-682-7000
okada.sy@fcho.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
| 2019 | Year | 06 | Month | 24 | 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
Terminated
Date of protocol fixation
| 2019 | Year | 05 | Month | 21 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 06 | Day |
Anticipated trial start date
| 2019 | Year | 07 | Month | 03 | Day |
Last follow-up date
| 2021 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study type: Observational study
Study design: Single arm study
Target: Cases admitted to Fukuoka Children's Hospital with a diagnosis of Kawasaki disease
Period: From June 2019 to May 2021
Management information
Registered date
| 2019 | Year | 06 | Month | 22 | Day |
Last modified on
| 2022 | Year | 02 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042179
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
