UMIN-CTR Clinical Trial

Basic information
Public title	Estimation of efficacy of Reduced form of Coenzyme Q10 (Ubiquinol) on QOL improvement in the elderly
Acronym	Estimation of efficacy of Reduced form of Coenzyme Q10 (Ubiquinol) on QOL improvement in the elderly
Scientific Title	Estimation of efficacy of Reduced form of Coenzyme Q10 (Ubiquinol) on QOL improvement in the elderly
Scientific Title:Acronym	Estimation of efficacy of Reduced form of Coenzyme Q10 (Ubiquinol) on QOL improvement in the elderly
Region	Japan

Condition
Condition	none
Classification by specialty	Surgery in general Blood transfusion Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Evaluate the efficacy of Reduced form of Coenzyme Q10 to several biological parameters relates to QOL in the elderly
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	SF-36 digit symbol test These items will be determined at 0, 6 and 12 months.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Reduced form of Coenzyme Q10 (100mg/day), 12 months,
Interventions/Control_2
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	60 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	The subject are healthy person over 60 years old.
Key exclusion criteria	1.Under medication. 2.Entry another clinical study which ongoing or performed within 3 month. 3.Doctor did not allow to entry to this study.
Target sample size	30

Research contact person
Name of lead principal investigator	1st name toshiki Middle name Last name mano
Organization	Tama University institute for healthcare
Division name	Tama University institute for healthcare
Zip code	108-0071
Address	Ramiaru Shiroganedai 503, 3-15-11, Shiroganedai, Minato-ku, Tokyo, Japan
TEL	03-5422-9995
Email	mano@tama.ac.jp

Public contact
Name of contact person	1st name Yo Middle name Last name Miyakoshi
Organization	KANEKA CORPORATION
Division name	QOL Division
Zip code	107-6028
Address	1-12-32, Akasaka, Minato-ku, Tokyo, Japan
TEL	050-3133-9895
Homepage URL
Email	Yo.miyakoshi@kaneka.co.jp

Sponsor
Institute	Tama University
Institute
Department

Funding Source
Organization	KANEKA CORPORATION
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	suda clinic
Address	2-8-14,takadanobaba,sinnjyuku-ku,tokyo,Japan
Tel	03-3207-8161
Email	yo.miyakoshi@kaneka.co.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	2016 Year 08 Month 31 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
Results
Results date posted
Results Delayed
Results Delay Reason
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	Completed
Date of protocol fixation	2015 Year 11 Month 09 Day
Date of IRB	2015 Year 11 Month 30 Day
Anticipated trial start date	2015 Year 11 Month 09 Day
Last follow-up date	2019 Year 09 Month 02 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 08 Month 30 Day
Last modified on	2019 Year 09 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000027473