UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020918 |
|---|---|
| Receipt number | R000024132 |
| Scientific Title | The relationship between B vitamins and brain atrophy of habitual drinkers |
| Date of disclosure of the study information | 2016/03/15 |
| Last modified on | 2016/02/07 19:27:15 |
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Basic information
Public title
The relationship between B vitamins and brain atrophy of habitual drinkers
Acronym
B vitamins and the alcohol-induced brain atrophy
Scientific Title
The relationship between B vitamins and brain atrophy of habitual drinkers
Scientific Title:Acronym
B vitamins and the alcohol-induced brain atrophy
Region
| Japan |
Condition
Condition
alcohol-induced brain atrophy
Classification by specialty
| Medicine in general | Endocrinology and Metabolism | Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To examine whether B vitamins decreases the rate of accelerated brain atrophy for habitual drinkers
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
brain volume, 6 months after the beginning
Key secondary outcomes
Homocysteine
vitamin B6
vitamin B12
folic acid
body conditions and feeling after alcohol drinking
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Gene | Food | Behavior,custom |
Interventions/Control_1
administration of oral dose of vitamin B6(20mg/d), B12(0.5mg/d), and folic acd (0.8mg/d) for 6 months
Interventions/Control_2
administration of oral dose of plasebo for 6 months
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
healthy persons who drink almost everyday
Key exclusion criteria
medical history of stroke and brain tumors
surgical history of brain
medication of vitamins
smoking
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kaechang Park |
Organization
Kochi Health Check-ups Clinic
Division name
Brain Ckeck-ups Center
Zip code
Address
2-4-36 Chiyori-cho Kochi city Kochi prefecture
TEL
088-883-9711
park@kenshin.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kaechang Park |
Organization
Kochi Health Check-ups Clinic
Division name
Brain Ckeck-ups Center
Zip code
Address
2-4-36 Chiyori-cho Kochi city Kochi prefecture
TEL
088-883-9711
Homepage URL
park@kenchin.or.jp
Sponsor or person
Institute
Kochi Unversity of Technology
Institute
Department
Personal name
Funding Source
Organization
Industrial Technology Center, Kochi prefecture
Organization
Division
Category of Funding Organization
Local Government
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
高知検診クリニック脳ドックセンター
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 03 | Month | 15 | 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
No longer recruiting
Date of protocol fixation
| 2015 | Year | 03 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 03 | Month | 15 | 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
| 2016 | Year | 02 | Month | 07 | Day |
Last modified on
| 2016 | Year | 02 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024132
