UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000054293
Receipt number R000062014
Scientific Title A Study on the practice and evaluation of health education for young women to promote Vitamin D intake
Date of disclosure of the study information 2024/07/01
Last modified on 2025/05/02 09:28:28

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Basic information

Public title

A Study on the practice and evaluation of health education for young women to promote Vitamin D intake

Acronym

A Study on the practice and evaluation of health education for young women to promote Vitamin D intake

Scientific Title

A Study on the practice and evaluation of health education for young women to promote Vitamin D intake

Scientific Title:Acronym

A Study on the practice and evaluation of health education for young women to promote Vitamin D intake

Region

Japan


Condition

Condition

The deficiency of Vitamin D

Classification by specialty

Nursing

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to investigate changes in vitamin D intake and blood 25OH vitamin D levels before and after health education to promote vitamin D intake in young women.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

25 OH vitamin D
Before health education and 3 months after it.

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification

NO

Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Food Behavior,custom

Interventions/Control_1

The health education to promote vitamin D intake to young women.

Interventions/Control_2

No Intervention.

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

18 years-old <=

Age-upper limit

25 years-old >=

Gender

Female

Key inclusion criteria

Female university student who belong to Kobe University School of Medicine Faculty of Health Sciences.
Female graduate student who belong to Kobe University Graduate School of Health Sciences.

Key exclusion criteria

Have a history pregnancy.
Need to control the diet due to the disease.
Have been diagnosed with rickets by a doctor.

Target sample size

130


Research contact person

Name of lead principal investigator

1st name Natsuko
Middle name
Last name Motooka

Organization

Kobe University

Division name

Graduate School of Health Science

Zip code

654-0142

Address

7-10-2, Tomogaoka, Suma-ku, Kobe

TEL

0787964583

Email

motooka.n@harbor.kobe-u.ac.jp


Public contact

Name of contact person

1st name Natsuko
Middle name
Last name Motooka

Organization

Kobe University

Division name

Graduate School of Health Science

Zip code

654-0142

Address

7-10-2, Tomogaoka, Suma-ku, Kobe

TEL

0787964583

Homepage URL


Email

motooka.n@harbor.kobe-u.ac.jp


Sponsor or person

Institute

Kobe University

Institute

Department

Personal name



Funding Source

Organization

Institute for Food and Health Science, Yazuya Co. Ltd.

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Kobe University

Address

7-10-2, Tomogaoka, Suma-ku, Kobe

Tel

078-796-4502

Email

syomu2@ams.kobe-u.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

2024 Year 07 Month 01 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

Enrolling by invitation

Date of protocol fixation

2024 Year 07 Month 01 Day

Date of IRB

2024 Year 08 Month 28 Day

Anticipated trial start date

2024 Year 08 Month 28 Day

Last follow-up date

2025 Year 11 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2024 Year 05 Month 01 Day

Last modified on

2025 Year 05 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062014