UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009784
Receipt number R000011092
Scientific Title Evaluating validity of dietary salt intake assessment: Dietary survey among Japanese Hemodialysis patients
Date of disclosure of the study information 2013/01/21
Last modified on 2016/01/18 11:22:39

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Basic information

Public title

Evaluating validity of dietary salt intake assessment: Dietary survey among Japanese Hemodialysis patients

Acronym

Dietary salt intake assessment in HD patients

Scientific Title

Evaluating validity of dietary salt intake assessment: Dietary survey among Japanese Hemodialysis patients

Scientific Title:Acronym

Dietary salt intake assessment in HD patients

Region

Japan


Condition

Condition

Chronic kidney disease on maintenance hemodialysis

Classification by specialty

Nephrology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Survey accurate dietary sodium intake and demonstrate predictive formula in japanese maintenance hemodialysis patients


Basic objectives2

Others

Basic objectives -Others

validation

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

dietary sodium intake

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

20 years-old <

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

maintenance hemodialysis stable patients
age>20 yr

Key exclusion criteria

exclude infection, GI trouble, malignancy, acute phase of CVA patients

Target sample size

200


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kiyomi Koike

Organization

Department of Medicine, Kurume University School of Medicine

Division name

Divisions of Nephrology

Zip code


Address

67 Asahi-machi, Kurume, Fukuoka 830-0011

TEL

0942-35-3311(5346)

Email

koike_kiyomi@kurume-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kiyomi Koike

Organization

Department of Medicine, Kurume University School of Medicine

Division name

Divisions of Nephrology

Zip code


Address

Asahi-machi,67, Kurume, Fukuoka, Japan

TEL

0942-35-3311

Homepage URL


Email

koike_kiyomi@kurume-u.ac.jp


Sponsor or person

Institute

Divisions of Nephrology, Department of Medicine, Kurume University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Japanese Association of Dialysis Physicians

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


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

2013 Year 01 Month 21 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

2013 Year 01 Month 21 Day

Date of IRB


Anticipated trial start date

2013 Year 01 Month 21 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Follow up the patients survival and nutrition status.


Management information

Registered date

2013 Year 01 Month 15 Day

Last modified on

2016 Year 01 Month 18 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011092


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name