UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026064 |
|---|---|
| Receipt number | R000029941 |
| Scientific Title | A study for evaluating the effect to the physical condition of the highly-concentrated vitamin B6, B12, and folate |
| Date of disclosure of the study information | 2017/02/13 |
| Last modified on | 2017/08/14 17:10:58 |
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Basic information
Public title
A study for evaluating the effect to the physical condition of the highly-concentrated vitamin B6, B12, and folate
Acronym
A study for evaluating the effect to the physical condition of the highly-concentrated vitamin B6, B12, and folate
Scientific Title
A study for evaluating the effect to the physical condition of the highly-concentrated vitamin B6, B12, and folate
Scientific Title:Acronym
A study for evaluating the effect to the physical condition of the highly-concentrated vitamin B6, B12, and folate
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This open test trial evaluates whether there is an effect of rich juice of vitamin B6, B12, C and folate in body condition for 30days
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Subject quality of their sleep before and after an intake of vitamin rich juice for 30days
Key secondary outcomes
Subject quality of their daily fatigue and drunkness before and after an intake of vitamin rich juice for 30days
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food |
Interventions/Control_1
Oral ingestion of the juice containing vitamin B6 10mg, B12 250maicrog, C 60mg and folate 400maicrog for 15days.Then oral ingestion of water for 15days.
Interventions/Control_2
Oral ingestion of water for 15days.Then oral ingestion of the juice containing vitamin B6 10mg, B12 250maicrog, C 60mg and folate 400maicrog for 15days.
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
| 30 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Health person who drink alcohl
Key exclusion criteria
No-medication
Person with no-food allergies
No-supplimentation of vitamin B6, B12, C and folate
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Watanabe |
Organization
University of Kochi
Division name
Faculty of Nutrition, Laboratory of Food Science
Zip code
Address
2751-1 Ike, kochi-city, kochi
TEL
088-847-8598
watana@cc.u-kochi.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshino Okamoto |
Organization
kochi Prefectural Industrial Technology Center
Division name
Food Development Section
Zip code
Address
3992-3 Nunoshida, kochi-city, kochi
TEL
088-846-1111
Homepage URL
yoshino_okamoto@ken2.pref.kochi.lg.jp
Sponsor or person
Institute
University of Kochi
Kochi Prefectural Industrial Technology Center
Suigei corporation
Institute
Department
Personal name
Funding Source
Organization
Kochi Industrial Promotion Center
Organization
Division
Category of Funding Organization
Non profit foundation
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
高知県立大学（高知県）、高知県工業技術センター（高知県）、酔鯨酒造株式会社（高知県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 02 | Month | 13 | 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
| 2017 | Year | 02 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 02 | Month | 13 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 02 | Month | 09 | Day |
Last modified on
| 2017 | Year | 08 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029941
| 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 |
