UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001972 |
|---|---|
| Receipt number | 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 00:52:22 |
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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
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
syfujiwara@jichi.ac.jp
Sponsor or person
Institute
Mima City National Health Insurance Koyadaira Clinic
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002407
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
