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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000018718
Receipt No. 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 2020/09/01

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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
Email 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
Email tomo-n@fujita-hu.ac.jp

Sponsor
Institute Fujita Health University Department of Anesthesiology and Critical Care
Institute
Department

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
Email 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
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
2020 Year 09 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021659

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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