UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031167 |
|---|---|
| Receipt number | R000035540 |
| Scientific Title | Measurement of blood concentration of vitamins in disabled elderly people and study of effects of intake of food containing BCAA (pilot study) |
| Date of disclosure of the study information | 2018/03/31 |
| Last modified on | 2018/08/08 13:26:07 |
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Basic information
Public title
Measurement of blood concentration of vitamins in disabled elderly people and study of effects of intake of food containing BCAA (pilot study)
Acronym
Measurement of blood concentration of vitamins in disabled elderly people and study of effects of intake of food containing BCAA (pilot study)
Scientific Title
Measurement of blood concentration of vitamins in disabled elderly people and study of effects of intake of food containing BCAA (pilot study)
Scientific Title:Acronym
Measurement of blood concentration of vitamins in disabled elderly people and study of effects of intake of food containing BCAA (pilot study)
Region
| Japan |
Condition
Condition
Elderly people who live in senior citizens health facilities
Classification by specialty
| Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the increase in blood concentration of vitamins by ingesting food containing BCAA.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Blood concentrations of VB1, VB2, VB6
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
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Ingestion of the test food once daily for 4 weeks
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Persons who are judged to be rank A, B, C in the determination of bedridden degree
2)Persons who plan to live in a senior citizen health facility within 1 month
3)Persons who can eat daily and can ingest the test food continually
4)Persons who can provide informed consent
Key exclusion criteria
1)Persons with severe diabetes
2)Persons with severe hepatic dysfunction
3)Persons with severe renal dysfunction
4)Persons who take supplements before or during the observation period
5)Persons with congenital amino acid metabolism abnormality
6)Persons who are allergic to milk ingredients
7)Persons who are judged ineligible by the principal investigator
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Tsuchiya |
Organization
Sendai City Medical Center Sendai Open Hospital
Division name
director
Zip code
Address
5-22-1, Trugaya, Miyagino-ku, Sendai 98-0824, Japan
TEL
022-252-1111
tsuchiya@openhp.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takashi Tsuchiya |
Organization
Sendai City Medical Center Sendai Open Hospital
Division name
director
Zip code
Address
5-22-1, Trugaya, Miyagino-ku, Sendai 98-0824, Japan
TEL
022-252-1111
Homepage URL
tsuchiya@openhp.or.jp
Sponsor or person
Institute
Moniwadai houreihome
Institute
Department
Personal name
Funding Source
Organization
Otsuka Pharmaceutical Factory
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
| 2018 | Year | 03 | 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
| 2017 | Year | 12 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
| 2018 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
| 2018 | Year | 05 | Month | 01 | Day |
Date analysis concluded
| 2018 | Year | 07 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 02 | Month | 06 | Day |
Last modified on
| 2018 | Year | 08 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035540
