UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000042030 |
|---|---|
| Receipt number | R000047969 |
| Scientific Title | Vitamin B12 and folic acid intake and cognitive function in the elderly with dementia |
| Date of disclosure of the study information | 2025/11/30 |
| Last modified on | 2023/10/27 11:45:44 |
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Basic information
Public title
Vitamin B12 and folic acid intake and cognitive function in the elderly with dementia
Acronym
Vitamin B12 and folic acid intake and cognitive function in the elderly with dementia
Scientific Title
Vitamin B12 and folic acid intake and cognitive function in the elderly with dementia
Scientific Title:Acronym
Vitamin B12 and folic acid intake and cognitive function in the elderly with dementia
Region
| Japan |
Condition
Condition
dementia
Classification by specialty
| Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify whether elderly people with dementia have sufficient intake of vitamin B12 and folic acid, which are involved in cognitive function.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Serum vitamin B12 concentration
Key secondary outcomes
Serum folate concentration
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
Prevention
Type of intervention
| Food |
Interventions/Control_1
Add one egg daily
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Dementia group home resident
Key exclusion criteria
Non-compliance
Target sample size
18
Research contact person
Name of lead principal investigator
| 1st name | Naoto |
| Middle name | |
| Last name | Fukuyama |
Organization
Tokyo University of Agriculture
Division name
Nutrition
Zip code
156-8502
Address
1-1-1 Sakuragaoka Setagaya Tokyo
TEL
0354772455
nf207182@nodai.ac.jp
Public contact
Name of contact person
| 1st name | Toshiki |
| Middle name | |
| Last name | Tanaka |
Organization
Tokyo University of Agriculture
Division name
Research institute for agriculture and life science
Zip code
156-8502
Address
1-1-1 Sakuragaoka Setagaya Tokyo
TEL
0354772562
Homepage URL
t3tanaka@nodai.ac.jp
Sponsor or person
Institute
Tokyo University of Agriculture
Institute
Department
Personal name
Funding Source
Organization
Tokyo University of Agriculture
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo University of Agriculture
Address
1-1-1 Sakuragaoka Setagaya Tokyo
Tel
0354772455
nf207182@nodai.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
| 2025 | Year | 11 | Month | 30 | 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
| 2020 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 09 | Day |
Anticipated trial start date
| 2020 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 10 | Month | 06 | Day |
Last modified on
| 2023 | Year | 10 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000047969
