UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012673
Receipt number R000014816
Scientific Title Assesment of association between Vitamin D receptor activator and circadian rhythm of blood presure; A observational cohort study
Date of disclosure of the study information 2014/01/01
Last modified on 2013/12/24 22:09:15

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Basic information

Public title

Assesment of association between Vitamin D receptor activator and circadian rhythm of blood presure; A observational cohort study

Acronym

Assesment of association between Vitamin D receptor activator and circadian rhythm of blood presure

Scientific Title

Assesment of association between Vitamin D receptor activator and circadian rhythm of blood presure; A observational cohort study

Scientific Title:Acronym

Assesment of association between Vitamin D receptor activator and circadian rhythm of blood presure

Region

Japan


Condition

Condition

Chronic kidney disease

Classification by specialty

Cardiology Endocrinology and Metabolism Nephrology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We assess the effect of vitamin D receptor activator on circulation system by evaluating the association between use of Vitamin D receptor activator and circadian rhythm of blood pressure.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The circadian rhythm of blood pressure on the point of educational hospitalization and three months after educational hospitalization.

Key secondary outcomes

Validity in blood pressure in night time and daytime, mean blood pressure, left ventricular mass index, and congestive heart failure on first dialysis.


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

100 years-old >=

Gender

Male and Female

Key inclusion criteria

All patients who admit to kidney disease center of Japanese Red Cross Nagoya Daini hospital for educational hospitalization.

Key exclusion criteria

Younger than 20 years old
older than 100 years old

Target sample size

250


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kunio Morozumi

Organization

Japanese Red Cross Nagoya Daini Hospital

Division name

Department of nephrology

Zip code


Address

2-9 Myoken-cho, showa-ku, Nagoya japan

TEL

052-832-1121

Email

morozumi@nagoya2.jrc.or.jp


Public contact

Name of contact person

1st name
Middle name
Last name Shinichi Sueta

Organization

Japanese Red Cross Nagoya Daini Hospital

Division name

Department of nephrology

Zip code


Address

2-9 Myoken-cho, showa-ku, Nagoya japan

TEL

052-832-1121

Homepage URL


Email

sueta.shinichi@gmail.com


Sponsor or person

Institute

Kidney Disease Center, Japanese Red Cross Nagoya Daini Hospital

Institute

Department

Personal name



Funding Source

Organization

No funding source

Organization

Division

Category of Funding Organization

Self funding

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

2014 Year 01 Month 01 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

2013 Year 12 Month 31 Day

Date of IRB


Anticipated trial start date

2014 Year 01 Month 06 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Subjects are all patients admitting to Kidney Disease Center of Japanese Red Cross Nagoya Daini Hospital. We assess the association between Vitamin D receptor activator and circadian rhythm of blood pressure.


Management information

Registered date

2013 Year 12 Month 24 Day

Last modified on

2013 Year 12 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014816


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name