UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018718 |
|---|---|
| Receipt number | R000021659 |
| Scientific Title | Assessing Bioavailability of CoQ10 Supplementation in Intensive Care Patients |
| Date of disclosure of the study information | 2015/08/24 |
| Last modified on | 2022/03/12 03:13:24 |
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Basic information
Public title
Assessing Bioavailability of CoQ10 Supplementation in Intensive Care Patients
Acronym
CoQ10 Supplementation in ICU patients
Scientific Title
Assessing Bioavailability of CoQ10 Supplementation in Intensive Care Patients
Scientific Title:Acronym
CoQ10 Supplementation in ICU patients
Region
| Japan | North America |
Condition
Condition
Valvular heart disease
Classification by specialty
| Anesthesiology | Cardiovascular surgery | Intensive care medicine |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To study the effect of CoQ10 supplementation on mitochondrial function, metabolism and immune function in intensive care patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Plasma and intracellular coenzyme Q10 levels and inflammatory cytokine levels
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
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Supplementation of reduced CoQ10
Interventions/Control_2
Supplementation of placebo
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
Preoperative patients for cardiovascular surgery using cardiopulmonary bypass with postoperative admission to the ICU.
Key exclusion criteria
Pregnant women, patients unable to communicate and patients with soy beans allergy.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Osamu |
| Middle name | |
| Last name | Nishida |
Organization
Fujita Health University
Division name
Department of Anesthesiology and Critical Care Medicine
Zip code
470-1192
Address
1-98 Dengakugakubo,Kutsukake-cho,Toyoake,Aichi.Japan
TEL
0562-93-2000
nishida@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | Tomoyuki |
| Middle name | |
| Last name | Nakamura |
Organization
Fujita Health University
Division name
Department of Anesthesiology and Critical Care Medicine
Zip code
470-1192
Address
1-98 Dengakugakubo,Kutsukake-cho,Toyoake,Aichi.Japan
TEL
0562-93-2000
Homepage URL
tomo-n@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University Department of Anesthesiology and Critical Care
Institute
Department
Personal name
Funding Source
Organization
Fujita Health University Department of Anesthesiology and Critical Care
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
KANEKA Coporation
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fujita Health university
Address
1-98 Dengakugakubo,Kutsukake-cho,Toyoake,Aichi.Japan
Tel
0562-93-2865
f-irb@fujita-hu.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
| 2015 | Year | 08 | 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
39
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
The samples have not been measured.
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
No longer recruiting
Date of protocol fixation
| 2015 | Year | 06 | Month | 08 | Day |
Date of IRB
| 2015 | Year | 07 | Month | 19 | Day |
Anticipated trial start date
| 2015 | Year | 08 | Month | 24 | Day |
Last follow-up date
| 2024 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 08 | Month | 19 | Day |
Last modified on
| 2022 | Year | 03 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021659
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
