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Intravenous immunoglobulin therapy combined with Vitamins E and C for Kawasaki Disease

Intravenous immunoglobulin therapy combined with Vitamins E and C for Kawasaki Disease - VITAMEC study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000037134
Enrollment
20
Registered
2019-06-24
Start date
2019-07-03
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kawasaki disease

Interventions

None listed

Sponsors

Fukuoka Children's Hospital Kawasaki disease center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
The time from the start of treatment to fever reduction

Secondary

MeasureTime frame
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)

Countries

Japan

Contacts

Public ContactYumi Mizuno

Fukuoka Children's Hospital Kawasaki disease center

mizuno.y@fcho.jp092-682-7000

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026