UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000039114
Receipt number R000044606
Scientific Title The study of food intake and nutrition status of the inhabitants in Djibouti.
Date of disclosure of the study information 2020/02/18
Last modified on 2020/01/10 08:34:50

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Basic information

Public title

The study of food intake and nutrition status of the inhabitants in Djibouti.

Acronym

The study of food intake and nutrition status of the inhabitants in Djibouti.

Scientific Title

The study of food intake and nutrition status of the inhabitants in Djibouti.

Scientific Title:Acronym

The study of food intake and nutrition status of the inhabitants in Djibouti.

Region

Africa


Condition

Condition

malnutrition

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The aim of this study was to examine food intake and nutritional status of the inhabitants in Djibouti.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

We examine the body weight and skeletal muscle such as nutritional states of inhabitant.

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

12 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

The inhabitants fulfilling all of the following criteria were subjected to the survey.
1. Healthful persons
2. Inhabitants of either gender
3. Inhabitants who understood the purpose of experiment and signed a consent form

Key exclusion criteria

1. When the inhabitant does not agree to the experiment.
2. When the doctor determines that the survey is not medically or ethically adequate to the inhabitant.

Target sample size

300


Research contact person

Name of lead principal investigator

1st name Noriaki
Middle name
Last name Wakana

Organization

Tokyo university of agriculture

Division name

Faculty of applied biosciences, Department of nutritional science

Zip code

154-8502

Address

1-1-1, sakuragaoka, setagaya-ku, Tokyo

TEL

03-5477-2456

Email

n3wakana@nodai.ac.jp


Public contact

Name of contact person

1st name Noriaki
Middle name
Last name Wakana

Organization

Tokyo university of agriculture

Division name

Faculty of applied biosciences, Department of nutritional science

Zip code

154-8502

Address

1-1-1, sakuragaoka, setagaya-ku, Tokyo

TEL

03-5477-2456

Homepage URL


Email

n3wakana@nodai.ac.jp


Sponsor or person

Institute

Tokyo university of agriculture

Institute

Department

Personal name



Funding Source

Organization

Tokyo university of agriculture

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

the Ethics Committee at the Tokyo University of Agriculture

Address

Sakuragaoka 1-1-1, Setagaya, Tokyo

Tel

03-5477-2456

Email

n3wakana-tua@umin.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

2020 Year 02 Month 18 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

Preinitiation

Date of protocol fixation

2020 Year 01 Month 15 Day

Date of IRB


Anticipated trial start date

2020 Year 02 Month 18 Day

Last follow-up date

2022 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

this study was observational study that examine food intake and nutritional status of inhabitants in Djibouti.


Management information

Registered date

2020 Year 01 Month 10 Day

Last modified on

2020 Year 01 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044606


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name