UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000029309
Receipt number R000033488
Scientific Title A Cross-sectional study on childhood development and daily intake
Date of disclosure of the study information 2017/10/04
Last modified on 2018/03/29 09:23:15

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Basic information

Public title

A Cross-sectional study on childhood development and daily intake

Acronym

Childhood development and daily intake

Scientific Title

A Cross-sectional study on childhood development and daily intake

Scientific Title:Acronym

Childhood development and daily intake

Region

Japan


Condition

Condition

Not applicable

Classification by specialty

Not applicable Child

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the daily intakes of nutrition in childhood.

Basic objectives2

Others

Basic objectives -Others

A Cross-sectional study

Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Daily intakes of nutrition
Questionnaire of life style

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

2 years-old <=

Age-upper limit

5 years-old >

Gender

Male and Female

Key inclusion criteria

1) More than 2 years and less than 5 years old
2) Subjects who have no problems in daily life.

Key exclusion criteria

1) Subjects who are judged inappropriate for the study.

Target sample size

900


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Chiharu Tsutsumi

Organization

Sagami Women's University

Division name

Faculty of Nutritional Science Department of Nutrition and Health

Zip code


Address

2-1-1 Bunkyo, Minami-ku, Sagamihara -City, Kanagawa-pref.

TEL

042-742-2013

Email

c-tsutsumi@star.sagami-wu.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yohei Kitamura

Organization

Morinaga Milk Industry Co., LTD.

Division name

Wellness & Nutrition Science Institute, R&D Division

Zip code


Address

1-83,5-Chome, Higashihara, Zama-City, Kanagawa-pref.

TEL

046-252-3046

Homepage URL


Email

yo_kitamura@morinagamilk.co.jp


Sponsor or person

Institute

Sagami Women's University

Institute

Department

Personal name



Funding Source

Organization

Morinaga Milk Industry Co., LTD.

Organization

Division

Category of Funding Organization

Profit organization

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

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

2017 Year 10 Month 04 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

2017 Year 09 Month 13 Day

Date of IRB


Anticipated trial start date

2017 Year 10 Month 04 Day

Last follow-up date

2018 Year 03 Month 31 Day

Date of closure to data entry

2018 Year 03 Month 31 Day

Date trial data considered complete

2018 Year 03 Month 31 Day

Date analysis concluded



Other

Other related information

We investigate the daily intakes of nutrition and life-style in childhood.


Management information

Registered date

2017 Year 09 Month 27 Day

Last modified on

2018 Year 03 Month 29 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033488


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name