UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032877 |
|---|---|
| Receipt number | R000037489 |
| Scientific Title | The effect of zinc supplementation in the sepsis patients |
| Date of disclosure of the study information | 2018/06/06 |
| Last modified on | 2025/04/23 18:22:37 |
* 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
The effect of zinc supplementation in the sepsis patients
Acronym
Zinc and sepsis
Scientific Title
The effect of zinc supplementation in the sepsis patients
Scientific Title:Acronym
Zinc and sepsis
Region
| Japan |
Condition
Condition
Sepsis
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose is that zinc supplementation in the sepsis patients contributes the mortality, coagulopathy or DIC.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
The improvement of DIC score in 7th day after admission
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
The administration of NOBELZIN 50mg 100mg/day for 7 days at least
Interventions/Control_2
The none of administration
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The sepsis patients using Sepsis-3 criteria
The patients living over 48 hours
The patients can get tube feeding or oral feeding within 48 hours after admission
The patients within 72 hours after admission
The serum zinc below 60 ug/dL within 48 hours after admission
Key exclusion criteria
cardiopulmonary arrest on arrival
dialyzed patient
liver cirrhosis patients
pregnant female
cardiogenic shock patients
cancer bearing patients
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Irie |
| Middle name | |
| Last name | Yuhei |
Organization
Fukuoka university hospital
Division name
The department of emergency and critical care
Zip code
8140180
Address
7-45-1 Nanakuma Johnan-ku Fukuoka city
TEL
092-801-1011
iriey@fukuoka-u.ac.jp
Public contact
Name of contact person
| 1st name | Irie |
| Middle name | |
| Last name | Yuhei |
Organization
Fukuoka university hospital
Division name
The department of emergency and critical care
Zip code
8140180
Address
7-45-1 Nanakuma Johnan-ku Fukuoka city
TEL
092-801-1011
Homepage URL
iriey@fukuoka-u.ac.jp
Sponsor or person
Institute
Fukuoka university
Institute
Department
Personal name
Funding Source
Organization
Fukuoka university
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fukuoka University Hospital
Address
7-45-1 Nanakuma Johnanku Fukuoka city
Tel
0928011011
iriey@fukuoka-u.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
| 2018 | Year | 06 | Month | 06 | Day |
Related information
URL releasing protocol
none
Publication of results
Unpublished
Result
URL related to results and publications
none
Number of participants that the trial has enrolled
0
Results
none
Results date posted
| 2025 | Year | 04 | Month | 23 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
none
Participant flow
none
Adverse events
none
Outcome measures
none
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2018 | Year | 06 | Month | 06 | Day |
Date of IRB
| 2018 | Year | 06 | Month | 06 | Day |
Anticipated trial start date
| 2018 | Year | 06 | Month | 06 | Day |
Last follow-up date
| 2021 | 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
| 2018 | Year | 06 | Month | 05 | Day |
Last modified on
| 2025 | Year | 04 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037489
