UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012501 |
|---|---|
| Receipt number | R000014631 |
| Scientific Title | The health effect of reduced coenzyme Q10, mainly to natural immune activity; a pilot study |
| Date of disclosure of the study information | 2013/12/06 |
| Last modified on | 2013/12/05 15:18:27 |
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Basic information
Public title
The health effect of reduced coenzyme Q10, mainly to natural immune activity; a pilot study
Acronym
The effect of reduced coenzyme Q10 to natural immune activity
Scientific Title
The health effect of reduced coenzyme Q10, mainly to natural immune activity; a pilot study
Scientific Title:Acronym
The effect of reduced coenzyme Q10 to natural immune activity
Region
| Japan |
Condition
Condition
Nothing
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purposes of this study are to evaluate the health effect of reduced coenzyme Q10 by daily intake mainly to natural immunity, and to establish a smooth and safe manegement organization for clinical trials.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Frequency of cold-like symptoms
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
active group;
Participants take capsules containig 100mg of reduced coenzyme Q10 once a day after meal for sixteen weeks.
Interventions/Control_2
placebo group;
Participants take capsules not containig reduced coenzyme Q10 once a day after meal for sixteen weeks.
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Those who live in Kamijima town, Ehime prefecture.
(2) Those whose age at the time of informed consent is 40 years old to about 80 years old.
(3) Those who can understand the purpose and the contents of this study, and can agree with participation to this study by letter.
Key exclusion criteria
(1) The presence of allergic response to test foods.
(2) Those who have taken medical supplies or supplements which investigator judged that this study would be affected.
(3) Those who are during the medical treatment of critical diseases, such as cancer.
(4) Pregnancy or beast-feeding.
(5) In addition, those who were judged inadequate by investigator.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takeshi Tanigawa |
Organization
Graduate School of Medicine, Ehime University
Division name
Department of Public Health
Zip code
Address
Shizukawa, Toon-city, Ehime
TEL
089-960-5283
tt9178tt9178@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tetsu Kinoshita |
Organization
Community SHIN Science Co., Ltd.
Division name
Social Epidemiology Institute
Zip code
Address
160-4 Kishimachi, Matsuyama-city, Ehime
TEL
089-904-7811
Homepage URL
tetsu.prospective@gmail.com
Sponsor or person
Institute
Department of Public Health, Graduate School of Medicine, Ehime University
Institute
Department
Personal name
Funding Source
Organization
Kaneka Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2013 | Year | 12 | Month | 06 | 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
| 2012 | Year | 10 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 12 | Month | 03 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 12 | Month | 05 | Day |
Last modified on
| 2013 | Year | 12 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014631
| 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 |
