UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000005447
Receipt number R000006463
Scientific Title Evaluation of dietary intake in hemodialysis patients
Date of disclosure of the study information 2011/04/15
Last modified on 2019/10/20 12:55:28

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Basic information

Public title

Evaluation of dietary intake in hemodialysis patients

Acronym

Evaluation of dietary intake in hemodialysis patients

Scientific Title

Evaluation of dietary intake in hemodialysis patients

Scientific Title:Acronym

Evaluation of dietary intake in hemodialysis patients

Region

Japan


Condition

Condition

hemodialysis patients

Classification by specialty

Nephrology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To establish accuracy evaluation of dietary intake in hemodialysis patients

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

dietary energy intake

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification

NO

Dynamic allocation

NO

Institution consideration


Blocking

NO

Concealment

No need to know


Intervention

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Behavior,custom Maneuver

Interventions/Control_1

detailed record of dietary intake

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

40 years-old <=

Age-upper limit

80 years-old >=

Gender

Male and Female

Key inclusion criteria

Outpatient in dialysis clinics

Key exclusion criteria

patient who had received dialysis within two years

Target sample size

40


Research contact person

Name of lead principal investigator

1st name Kunihiro
Middle name
Last name Yamagata

Organization

University of Tsukuba

Division name

Department of nephrology

Zip code

305-8575

Address

1-1-1,Ten-nodai, Tsukuba, Ibaraki

TEL

029-853-3202

Email

k-yamaga@md.tsukuba.ac.jp


Public contact

Name of contact person

1st name Chie
Middle name
Last name Saito

Organization

University of Tsukuba

Division name

Department of nephrology

Zip code

305-8575

Address

1-1-1,Ten-nodai, Tsukuba, Ibaraki

TEL

029-853-3202

Homepage URL


Email

chie.saito@md.tsukuba.ac.jp


Sponsor or person

Institute

Department of nephrology, University of Tsukuba

Institute

Department

Personal name



Funding Source

Organization

Nonprofit Organization

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

University of Tsukuba

Address

2-1-1,Amakubo, Tsukuba, Ibaraki, Japan

Tel

029-853-3022

Email

sien.ningenss@un.tsukuba.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

筑波大学腎臓内科


Other administrative information

Date of disclosure of the study information

2011 Year 04 Month 15 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

50

Results


Results date posted


Results Delayed

Delay expected

Results Delay Reason

Data analysing

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

No longer recruiting

Date of protocol fixation

2010 Year 10 Month 21 Day

Date of IRB

2010 Year 10 Month 21 Day

Anticipated trial start date

2011 Year 04 Month 20 Day

Last follow-up date

2011 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2011 Year 04 Month 15 Day

Last modified on

2019 Year 10 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006463


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name