UMIN-CTR Clinical Trial

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	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000021659