UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005657 |
|---|---|
| Receipt number | R000006685 |
| Scientific Title | The Measurement and Influence of estimated Salt intake in 24-hour urine collection in chrOnic kidneY disease in Okayama Study |
| Date of disclosure of the study information | 2011/05/26 |
| Last modified on | 2012/01/30 19:31:02 |
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Basic information
Public title
The Measurement and Influence of estimated Salt intake in 24-hour urine collection in chrOnic kidneY disease in Okayama Study
Acronym
The MISOY-Okayama study
Scientific Title
The Measurement and Influence of estimated Salt intake in 24-hour urine collection in chrOnic kidneY disease in Okayama Study
Scientific Title:Acronym
The MISOY-Okayama study
Region
| Japan |
Condition
Condition
chronic kidney disease
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
There is a considerable body of literature linking higher salt intake with higher blood pressure, increased cardiovascular risk and renal dysfunction. It is recommended that the intake of dietary salt should be less than 6g per day in CKD practice guideline 2009 provided by Japanese Society of Nephrology. However, the effect of dietary salt intake on proteinuria, blood pressure and progression of chronic kidney disease (CKD) is still uncertain. Moreover, few studies based their assessments on 24-hour urinary sodium excretion, the most accurate approach to assess salt intake. The aim of this study is to determine the effect of salt intake estimated by 24-hour sodium excretion on blood pressure, proteinuria, and renal outcome.
Basic objectives2
Others
Basic objectives -Others
cross sectional study and observational study
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
doubling of serum creatinine or introducing of renal replacement therapy
Key secondary outcomes
blood pressure, rate of estimated glomerular filtration rate and rate of urinary protein excretion
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Outpatients of the Department of Nephrology of Okayama University Hospital who underwent 24-hour urine collection between April and June in 2007, not receiving renal replacement therapy
Key exclusion criteria
Patients who were lost to follow-up within 90 days from the initiation of observation
Patients who already received renal replacement therapy (hemodialysis, peritoneal dialysis and renal transplantation)
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Morinaga |
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name
Department of Medicine and Clinical Science
Zip code
Address
2-5-1 Shikata-cho, Kita-ku, Okayama City
TEL
086-235-7235
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Morinaga |
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name
Department of Medicine and Clinical Science
Zip code
Address
TEL
Homepage URL
morinaga@md.okayama-u.ac.jp
Sponsor or person
Institute
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Institute
Department
Personal name
Funding Source
Organization
None
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
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
| 2011 | Year | 05 | Month | 26 | 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
The median follow-up period was 36 months, during which time, sixteen of 159 patients reached the renal composite endpoint (10.1%). A significant correlation between the baseline systolic blood pressure and urinary sodium excretion was detected in both all individuals (r=0.2602; P=0.0009) and in female subjects (r=0.3308; P=0.0029). A similar correlation was found between log-transformed value of the baseline urinary protein excretion and urinary sodium excretion in the whole (r=0.1838; P=0.0239) and in the female (r=0.2766; P=0.0136) subjects. When the patients with CKD stage 4 and 5 were stratified according to the quartile levels of urinary sodium excretion of each gender, increase in urinary sodium excretion was a risk for the renal composite endpoint only in female subjects (P=0.0107, Log rank test). In the Cox regression analysis, the level of urinary sodium excretion was independently associated with the endpoint, but the risk was not independent of the urinary protein excretion.
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 | 05 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 06 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 06 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 11 | Month | 01 | Day |
Other
Other related information
The median follow-up period was 36 months, during which 16 reached the renal composite endpoint.
Management information
Registered date
| 2011 | Year | 05 | Month | 26 | Day |
Last modified on
| 2012 | Year | 01 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006685
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