UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057928 |
|---|---|
| Receipt number | R000066057 |
| Scientific Title | A cross-sectional study of thiamine deficiency in patients receiving home care |
| Date of disclosure of the study information | 2025/05/21 |
| Last modified on | 2025/05/21 13:06:07 |
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Basic information
Public title
A cross-sectional study of thiamine deficiency in patients receiving home care
Acronym
A cross-sectional study of thiamine deficiency in patients receiving home care
Scientific Title
A cross-sectional study of thiamine deficiency in patients receiving home care
Scientific Title:Acronym
A cross-sectional study of thiamine deficiency in patients receiving home care
Region
| Japan |
Condition
Condition
Home medical care
Classification by specialty
| Medicine in general | Psychiatry |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify prevalence of VB1 deficiency in patients receiving home medical care.
Basic objectives2
Others
Basic objectives -Others
To examine factors associated with the onset of VB1 deficiency in patients receiving home medical care.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
VB1 concentration
Key secondary outcomes
Items to be evaluated by blood test:
Albumin, LDL cholesterol, HDL cholesterol, CRP, LDH/IFCC, HbA1c, fasting blood glucose, creatinine
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
| Other |
Interventions/Control_1
Patients receiving home medical care from the clinic will be enrolled in the study. During routine blood sampling, which is conducted as part of standard medical care, an additional 2cc of blood will be drawn for the purpose of this study to measure the blood concentration of VB1.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Currently receiving home medical care from ANZ Clinic
2. Aged 20 years or older at time of consent
3. Provided written informed consent for participation in the study
Key exclusion criteria
1. Inability to provide blood sample
2. Considered inappropriate for the study by the investigators
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Hideki |
| Middle name | |
| Last name | Onishi |
Organization
Saitama Medical University International Medical Center
Division name
Psycho-Oncology
Zip code
3501298
Address
1397-1 Yamane, Hidaka, Saitama, Japan
TEL
0429844111
honishi@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | Nobuyuki |
| Middle name | |
| Last name | Onizawa |
Organization
Anz Clinic
Division name
Home care
Zip code
3501305
Address
2F Tajima building, 1-17-25, Irumagawa, Sayama-city, Saitama. Japan
TEL
04-2937-7053
Homepage URL
onizawa@anz-homecare.com
Sponsor or person
Institute
Saitama Medical University International Medical Center
Institute
Department
Personal name
Funding Source
Organization
Saitama Medical University International Medical Center
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Saitama Medical University International Medical Center Institutional Review Board
Address
1397-1 Yamane, Hidaka, Saitama, Japan
Tel
042-984-4523
imc_irb@saitama-med.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 | 05 | Month | 21 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 01 | Month | 07 | Day |
Date of IRB
| 2025 | Year | 03 | Month | 05 | Day |
Anticipated trial start date
| 2025 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 05 | Month | 21 | Day |
Last modified on
| 2025 | Year | 05 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066057
