UMIN-CTR Clinical Trial

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
Institute	Department of nephrology, University of Tsukuba
Institute
Department

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000006463