UMIN-CTR Clinical Trial

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
Email	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
Email	mizuno.y@fcho.jp

Sponsor
Institute	Fukuoka Children's Hospital Kawasaki disease center
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000042179