UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040675 |
|---|---|
| Receipt number | R000046425 |
| Scientific Title | The prevalence of vitamin B1 deficiency among elderly nursing home residents: A cross-sectional study |
| Date of disclosure of the study information | 2020/06/23 |
| Last modified on | 2021/06/08 11:35:36 |
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Basic information
Public title
The prevalence of vitamin B1 deficiency among elderly nursing home residents: A cross-sectional study
Acronym
Ogano Nursing Home Study 1
Scientific Title
The prevalence of vitamin B1 deficiency among elderly nursing home residents: A cross-sectional study
Scientific Title:Acronym
Ogano Nursing Home Study 1
Region
| Japan |
Condition
Condition
Vitamin B1 deficiency
Classification by specialty
| Medicine in general | Psychiatry | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Vitamin B1 (VB1) is an essential coenzyme for glucose metabolism, but it cannot be synthesized in vivo and therefore depends on ingestion from outside the body. However, the store of VB1 in the body is depleted within about 18 days, and deficiency is likely to occur if a decrease in food intake continues due to decreased appetite. The disease resulting from VB1 deficiency is Wernicke encephalopathy. Treatment involves the intravenous administration of VB1, and recovery is possible without any complications if detected early. However, delayed treatment can result in serious sequelae involving the nervous system (Korsakoff's syndrome) with a mortality rate of close to 20%.
In recent years, VB1 deficiency has been reported not only in patients with alcohol dependence and those with morning sickness, which have been considered to be common in the past, but also in cancer patients. Furthermore, it was reported that 14% of the patients admitted to the emergency department from nursing homes for the elderly had VB1 deficiency. In general, many elderly facility users have dementia, and most Alzheimer-type dementia patients have VB1 deficiency, and it was also revealed that VB1 deficiency is associated with worsening of the peripheral symptoms of dementia (BPSD) (Uchida et al., in press). If this study is able to clarify the rate of VB1 deficiency among institutional residents and its underlying factors, it will have a very significant impact on preventing serious side effects involving the nervous system.
Basic objectives2
Others
Basic objectives -Others
Items examined by blood sampling:
VB1
Items examined based on care and medical records:
Facility name, date of birth, gender, height, weight,
level of care provided, degree of independence (latest nursing care insurance certification result, or researcher evaluation)
Medical history [cancer (under treatment/ recovered), stroke, heart disease, diabetes, hypertension, hyperlipidemia, kidney disease, liver disease, respiratory disease, insomnia]
Blood sampling data (white blood cells, red blood cells, hemoglobin, hematocrit, platelets, blood glucose level, HbA1c, TG, HDL, LDL, GOT, GPT, gamma GTP, total protein, albumin, total bilirubin, LDH, amylase, urea nitrogen, creatinine, uric acid)
Examination of blood sampling results during health checkups
Food intake and appetite
Prescription drug survey (sleeping pills, vitamins, PPIs, antidiabetic medications)
Charlson Risk Index
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Vitamin B1
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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-Elderly persons aged 65 and over housed in Nursing Home
2-Persons subject to medical examinations conducted by the Nursing Home
3-Those who have provided written consent to be included in this research project
Key exclusion criteria
Those who judged to be inappropriate by the researchers
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | professor |
| Middle name | |
| Last name | Onishi |
Organization
Saitama Medical University International Medical Center
Division name
Department of Psycho-Oncology
Zip code
350-1298
Address
1397-1 Yamane, Hidaka-City, Saitama
TEL
0429844111
honishi@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | Hideki |
| Middle name | |
| Last name | Onishi |
Organization
Saitama International Medical Center Saitama Medical University
Division name
Department of Psycho-Oncology
Zip code
350-1298
Address
1397-1 Yamane, Hidaka-City, Saitama
TEL
0429844111
Homepage URL
honishi@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University
Institute
Department
Personal name
Funding Source
Organization
KAKENHI
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Oganomachi Central Medicine
Address
300, Ogano Oganomachi, Chichibu, Saitama
Tel
0494-75-2332
91007nu@jichi.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
| 2020 | Year | 06 | Month | 23 | 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 | 05 | Month | 31 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 02 | Day |
Anticipated trial start date
| 2020 | Year | 06 | Month | 23 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Cross-sectional study
Survey from blood samples "Vitamin B1"
Management information
Registered date
| 2020 | Year | 06 | Month | 06 | Day |
Last modified on
| 2021 | Year | 06 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046425
| Research Plan | |
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| Registered date | File name |
| Research case data | |
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