UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034402 |
|---|---|
| Receipt number | R000039231 |
| Scientific Title | A cross-sectional study on the prevalence of and factors related to vitamin B1 deficiency in a regional city: Ogano Study |
| Date of disclosure of the study information | 2018/10/09 |
| Last modified on | 2019/10/19 10:48:25 |
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Basic information
Public title
A cross-sectional study on the prevalence of and factors related to vitamin B1 deficiency in a regional city: Ogano Study
Acronym
Ogano Study 1
Scientific Title
A cross-sectional study on the prevalence of and factors related to vitamin B1 deficiency in a regional city: Ogano Study
Scientific Title:Acronym
Ogano 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
If vitamin B1 deficiency disease can be found at an early stage, the administration of vitamin B1 can resolve the condition without sequelae; however, if it is not found and the deficiency persists, it often leads to serious sequelae.
In recent years, reports on vitamin B 1 deficiency have involved not only hitherto recognized alcohol- and hyperemesis gravidarum-related cases, but the number of cases involving cancer patients have also increased. Further, cases of vitamin B1 deficiency in which the patients do not present with any clinical symptoms but the vitamin B1 level is below the normal lower limit have also been reported. Vitamin B1 deficiency can lead to vitamin B1 deficiency disease, so early detection is necessary. However, the prevalence of vitamin B1 deficiency in the general population and its background have not yet been clarified. If the prevalence of vitamin B 1 deficiency in the general population and its background factors can be clarified in this study, the possibility of preventing the onset of vitamin B1 deficiency will be increased and severe brain damage prevented, making this study particularly significant.
Basic objectives2
Others
Basic objectives -Others
Surveyed items from questionnaire responses: date of birth, gender, height, weight
History (cancer: under treatment/recovered), stroke, heart disease, diabetes, hypertension, hyperlipidemia, kidney disease, liver disease, respiratory disease)
Predilections (alcohol intake: type and quantity, tobacco use: Brinkman index)
Presence/absence of appetite loss (if present, to what degree)
Presence/absence of insomnia
Oral vitamin status
Presence/absence of pregnancy
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1-Residents who participated in the "Kenko Fureai Festival (Health friends Festival)"
2-Aged 20 years or older at the time consent was obtained
3-Provided written consent to participate in this study
4-Those able to complete the self-administered questionnaire
Key exclusion criteria
1-Those who judged to be inappropriate by the researchers
2-Those taking Vitamin B1 preparations (including supplements)
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideki Onishi |
Organization
Saitama Medical University International Medical Center
Division name
Department of Psycho-Oncology
Zip code
Address
1397-1, Yamane, Hidaka-city, Saitama
TEL
0429844111
honishi@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideki Onishi |
Organization
Saitama Medical University International Medical Center
Division name
Department of Psycho-Oncology
Zip code
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
Saitama Medical University
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
Address
Tel
Secondary IDs
Secondary IDs
YES
Study ID_1
Oganomachi Central Medicine IRB18
Org. issuing International ID_1
Oganomachi Central Medicine IRB
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
国保町立小鹿野中央病院（埼玉県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 10 | Month | 09 | 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
| 2018 | Year | 09 | Month | 20 | Day |
Date of IRB
| 2018 | Year | 09 | Month | 25 | Day |
Anticipated trial start date
| 2018 | Year | 10 | Month | 28 | Day |
Last follow-up date
| 2018 | Year | 12 | 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" and responses of the questionnaire at "Kenkou Fureai Festival (Health friends Festiva)"
Management information
Registered date
| 2018 | Year | 10 | Month | 07 | Day |
Last modified on
| 2019 | Year | 10 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039231
