UMIN-CTR Clinical Trial

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
Email	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
Email	honishi@saitama-med.ac.jp

Sponsor
Institute	Saitama Medical University
Institute
Department

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
Email

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039231