UMIN-CTR Clinical Trial

Public title

A study of physical and mental health maintenance and disease prevention at a regional city: Ogano Study 2

Acronym

Ogano Study 2

Scientific Title

A study of physical and mental health maintenance and disease prevention at a regional city: Ogano Study 2

Scientific Title:Acronym

Ogano Study 2

Region

Japan

Condition

Vitamin deficiency, Zinc deficiency

Classification by specialty

Medicine in general	Endocrinology and Metabolism	Geriatrics
Psychiatry

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

In Ogano Study1 in 2018, no one was deficient in vitamin B1. However, it was revealed that about half of the people experienced "insomnia". Therefore, Ogano Study 2 was developed with the aim of further developing Ogano Study 1 and mainly studying the relationship between the causes of "insomnia" from the physical and mental aspects.
There have been many studies on the causes of insomnia, but it can be roughly divided into physical and mental factors.
Therefore, in Ogano Study 2, in addition to vitamin B1, vitamin B12, folic acid, vitamin D, zinc, as well as VB12 and the possibility of anemia related to folic acid deficiency, the current state is clarified.
Next, as a research approach to the mental aspect, we will focus on depression, which has been reported to be associated with insomnia. Depression has been pointed out to continue to "depressive state", "adaptation disorder", and "Major Depressive Disorder", and insomnia is a typical symptom of depression, so attention should be paid in a preventive sense. In addition, bereavement has been reported as the largest risk factor for the onset of depression in the elderly, and confirmation of bereavement experience is important as a background of daily life.
Furthermore, we focus on "Fail" as a state related to both physical and mental aspects. Flail is defined as a state of increased vulnerability to health problems due to various functional changes and decreased reserve ability with age (Japan Geriatrics Society), and the average age of Ogano Study 1 participants was 65 years or older Even with that in mind, an assessment of flail is necessary.
Ogano Study 2 is planned based on the results obtained in Ogano Study1, and by addressing the potential risks by examining the current status of the physical and mental state of the study subjects, damage due to serious deficiency The purpose is to prevent health while preventing health.

Basic objectives2

Others

Basic objectives -Others

Investigation items by blood sampling: VB1, VB12, folic acid, VD, zinc, blood count (red blood cell count, white blood cell count, hemoglobin, hematocrit, platelet count, MCV, MCHC)

Questionnaire survey items: date of birth, gender, height, weight
Past history: (Cancer (under treatment / healing), stroke, heart disease, diabetes, hypertension, hyperlipidemia, kidney disease, liver disease, respiratory disease, gastrectomy)
Preferences: Alcohol intake (type / amount), smoking status (Brinkman index)
Appetite decline: If so, the extent
Insomnia
Recent bereavement experience (presence / absence, subject, date)
Screening for depression: Patient Health Questionnaire-2 (PHQ-2)
Status of internal use of vitamins, PPI, diabetes drugs, etc.
Pregnancy, menopause
Evaluation of flail for participants over 65 years old (Freid et al.); Weight loss, ease of fatigue, decreased physical activity, walking, decreased grip

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Vitamin B1 at study registration

Key secondary outcomes

Investigation items by blood sampling: VB12, folic acid, VD, zinc, blood count (red blood cell count, white blood cell count, hemoglobin, hematocrit, platelet count, MCV, MCHC)
Questionnaire survey items: date of birth, gender, height, weight
Past history: (Cancer (under treatment / healing), stroke, heart disease, diabetes, hypertension, hyperlipidemia, kidney disease, liver disease, respiratory disease, with or without gastrectomy)
Preferences: Alcohol intake (type / amount), smoking status (Brinkman index)
Appetite decline: If so, the extent
Insomnia
Recent bereavement experience (presence / absence, subject, date)
Screening for depression: Patient Health Questionnaire-2 (PHQ-2)
Status of internal use of vitamins, PPI, diabetes drugs, etc.
Pregnancy, menopause
Evaluation of flail for participants over 65 years old (Freid et al.); Weight loss, ease of fatigue, decreased physical activity, walking, decreased grip

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1) General residents who participated in the Health Fureai Festival
2) Person who is over 20 years old when obtaining consent
3) Those who have obtained consent for this research in writing
4) Those who can respond to the questionnaire

Key exclusion criteria

Those who are deemed inappropriate by the researcher

Target sample size

500

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

350-1298

Address

1397-1, Yamane, Hidaka-City, Saitama, Japan

TEL

+81429844640

Email

honishi@saitama-med.ac.jp

Name of contact person

1st name	Hideki
Middle name
Last name	Onishi

Organization

Saitama Medical University International Medical Center

Division name

Psycho Oncology

Zip code

350-1298

Address

1397-1, Yamane, Hidaka-City, Saitama, Japan

TEL

+81429844640

Homepage URL

Email

honishi@saitama-med.ac.jp

Institute

Saitama Medical University

Institute

Department

Personal name

Organization

Saitama Medical University

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Saitama Medical University International Medical Center

Address

1397-1, Yamane, Hidaka-City, Saitama, Japan

Tel

042-984-4523

Email

chikens@saitama-med.ac.jp

Secondary IDs

YES

Study ID_1

19-110

Org. issuing International ID_1

Saitama Medical University International Medical Center

Study ID_2

Ogano 13

Org. issuing International ID_2

Ogano Town Central Hospital

IND to MHLW

Institutions

Date of disclosure of the study information

2019

Year

10

Month

27

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

No longer recruiting

Date of protocol fixation

2019

Year

10

Month

01

Day

Date of IRB

2019

Year

10

Month

02

Day

Anticipated trial start date

2019

Year

10

Month

27

Day

Last follow-up date

2019

Year

12

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

The following describes the measurement items in Ogano Study 2, the scientific basis for the evaluation items, and the factors that examine the relevance.
Vitamin B1 (VB1) is an essential coenzyme for sugar metabolism, but it cannot be synthesized in vivo, so it depends on ingestion from outside the body. However, the amount of VB1 accumulated in the body is not sufficient for about 18 days, and deficiency is likely to occur if food intake continues to decline.
Vitamin B12 (VB12) is essential for normal red blood cell formation, nerve function, and DNA synthesis. Folic acid is also important as a coenzyme for substances involved in DNA synthesis together with VB12. When folic acid is deficient, giant erythroblasts appear. In addition to anemia, VB12 deficiency can cause potentially serious and irreversible damage to the brain and nerves. It is becoming clear that vitamin D is involved not only in bone metabolism but also in various biological phenomena. Zinc deficiency causes taste disorders, loss of appetite, stomatitis, and intractable pressure ulcers.
The effect of insomnia on health is significant. Insomnia is a risk factor for depression, and the risk is 2--9. Depression has been pointed out as a continuum from depression to adaptation disorder and depression, and it has been reported that the experience of bereavement may trigger the onset of depression in elderly people. Insomnia is a typical symptom of depression, so be careful.
This is a cross-sectional epidemiological study that targets VB1 and VB12 deficiency, folic acid, VD, zinc deficiency, anemia, insomnia and depression rates in the general population that have not been previously revealed, and the elderly. This is a study to clarify the current situation by evaluating the flail.

Registered date

2019

Year

10

Month

19

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=R000043692