UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001972
Receipt No. R000002407
Scientific Title Dietary salt reduction in rural patients with albuminurea using family and community support
Date of disclosure of the study information 2009/05/15
Last modified on 2009/05/15

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Dietary salt reduction in rural patients with albuminurea using family and community support
Acronym Dietary salt reduction in rural patients with albuminurea using family and community support
Scientific Title Dietary salt reduction in rural patients with albuminurea using family and community support
Scientific Title:Acronym Dietary salt reduction in rural patients with albuminurea using family and community support
Region
Japan

Condition
Condition Chronic kidney disease
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 A pilot study to compare a salt reduction intervention for albuminuria patients in a rural area using support from family and neighborhood residents to a usual care condition
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes Change in Albumin-to-creatinin ratio of urine measured before and after 3 month intervention
Key secondary outcomes Change in blood pressure measured before and after 3 month intervention

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 The patients in the intervention group, their families and neighborhood residents were educated in salt reduction for 2-hours at a town meeting hall and the patients and their families for 30-minutes at home by experienced dieticians on November 1st in 2006. Local health care professionals assisted with the intervention activities and followed the subjects for three months (from November 1st in 2006 to January 31st, 2007) at Koyadaira Clinic.
Interventions/Control_2 The patients in the control group received usual care, i.e. monthly visit and physician advice to reduce salt for 3 months (from November 1st in 2006 to January 31st, 2007).
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 All consecutive outpatients with albuminurea (urine albumin-creatinine ratio (ACR) >= 30) at Koyadaira Clinic from May to October, 2006
Key exclusion criteria None
Target sample size 35

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shinji Fujiwara
Organization Mima City National Health Insurance Koyadaira Clinic
Division name Department of internal medicine and general surgery
Zip code
Address 295 Kawai, Koyadaira, Mima City, Tokushima
TEL 0883-68-2541
Email

Public contact
Name of contact person
1st name
Middle name
Last name Shinji Fujiwara
Organization Mima City National Health Insurance Koyadaira Clinic
Division name Department of internal medicine and general surgery
Zip code
Address 295 Kawai, Koyadaira, Mima City, Tokushima
TEL 0883-68-2541
Homepage URL
Email syfujiwara@jichi.ac.jp

Sponsor
Institute Mima City National Health Insurance Koyadaira Clinic
Institute
Department

Funding Source
Organization The Foundation for Development of the Community (Japan)
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor National Hospital Organization Kyoto Medical Center
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
2009 Year 05 Month 15 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Of 37 subjects (20 male, 16 female, mean age; 72.8(DS 9.2) years), 36 completed the 3-month follow up and were analyzed. The albumin-to creatinin ratio of urine decreased significantly in the intervention group (706(1,081) to 440(656); t=2.282, p=0.04), and the effect approached significance in comparison to the control group (213(322) to 163(162); F=3.5, p=0.07).
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
2006 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2006 Year 11 Month 01 Day
Last follow-up date
2007 Year 03 Month 01 Day
Date of closure to data entry
2007 Year 04 Month 01 Day
Date trial data considered complete
2007 Year 04 Month 01 Day
Date analysis concluded
2007 Year 10 Month 01 Day

Other
Other related information

Management information
Registered date
2009 Year 05 Month 15 Day
Last modified on
2009 Year 05 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002407

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.