UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000014935
Receipt number R000017378
Scientific Title Effect of salt reduction by aggressive nutritional education on clinic, home, and ambulatory BP levels
Date of disclosure of the study information 2014/08/24
Last modified on 2014/08/24 12:41:45

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Basic information

Public title

Effect of salt reduction by aggressive nutritional education on clinic, home, and ambulatory BP levels

Acronym

Effect of salt reduction on blood pressure

Scientific Title

Effect of salt reduction by aggressive nutritional education on clinic, home, and ambulatory BP levels

Scientific Title:Acronym

Effect of salt reduction on blood pressure

Region

Japan


Condition

Condition

Stable hypertensive outpatients who are performing antihypertensive and non-antihypertensive treatment.

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigete the effect of salt restrictive education by doctor and dietitian on blood pressure in the area of high amount of salt intake.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Diffrence in blood pressure-lowering effect

Key secondary outcomes

Pulse wave velocity (PWV)
Augmentation index (AI)


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification

NO

Dynamic allocation

NO

Institution consideration


Blocking


Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Behavior,custom

Interventions/Control_1

aggressive nutritional education

Interventions/Control_2

control

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

Stable hypertensive outpatients who are performing antihypertensive and non-antihypertensive treatment.

Key exclusion criteria

1. Hemodialysis
2. Dementia from whom we cannot obtain informed consent.

3 for whom the attending doctor considerd he or she is not appropriate for the study.

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kazuomi Kario

Organization

Jichi Medical University School of Medicine

Division name

Division of Cardiovascular Medicine, Departmentof Medicine

Zip code


Address

3311-1 Yakusiji,Shimotsuke, Tochigi 329-0498, Japan

TEL

0285-58-7344

Email

kkario@jichi.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Masahiro Nakano

Organization

Jichi Medical University School of Medicine

Division name

Division of Cardiovascular Medicine, Departmentof

Zip code


Address

3311-1 Yakusiji,Shimotsuke, Tochigi 329-0498, Japan

TEL

0285587344

Homepage URL


Email

nakachan727@heart.ocn.ne.jp


Sponsor or person

Institute

Jichi Medical University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Jichi Medical University School of Medicine

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor

Jichi Medical University School of Medicine

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

自治医科大学附属病院(栃木県)


Other administrative information

Date of disclosure of the study information

2014 Year 08 Month 24 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

2011 Year 06 Month 01 Day

Date of IRB


Anticipated trial start date

2011 Year 09 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2014 Year 08 Month 24 Day

Last modified on

2014 Year 08 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017378


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name