UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017853 |
|---|---|
| Receipt number | R000020682 |
| Scientific Title | Efficacy of n-3 polyunsaturated fatty acids in hemodialysis patients with dyslipidemia |
| Date of disclosure of the study information | 2015/06/10 |
| Last modified on | 2015/06/10 01:58:12 |
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Basic information
Public title
Efficacy of n-3 polyunsaturated fatty acids in hemodialysis patients with dyslipidemia
Acronym
Efficacy of n-3 polyunsaturated fatty acids in hemodialysis patients with dyslipidemia
Scientific Title
Efficacy of n-3 polyunsaturated fatty acids in hemodialysis patients with dyslipidemia
Scientific Title:Acronym
Efficacy of n-3 polyunsaturated fatty acids in hemodialysis patients with dyslipidemia
Region
| Japan |
Condition
Condition
chronic kidney disease, dyslipidemia
Classification by specialty
| Medicine in general | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of usefulness and safety of n-3 polyunsaturated fatty acids
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
evaluation of changes in atherosclerosis indexes, blood pressure variability
Key secondary outcomes
changes in coagulation, inflammation-related index and dialysis-related index
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
4g of omega-3 fatty acid ethyl granular capsule for 3 months
Interventions/Control_2
no administration of omega-3 fatty acid ethyl granular capsule for 3 months, then 2g administration of omega-3 fatty acid ethyl granular capsule for 3 months (if patient wish to do)
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
1. Age of 20 years old or older
2. Patients without administration of n-3 polyunsaturated fatty acids (including supplements) at least for 6 months
3. Patients who have voluntarily provided written informed consent after fully understanding the information given about participation in the study.
Key exclusion criteria
1. History of allergy to n-3 polyunsaturated fatty acids
2. Pregnant women or women suspected of being pregnant
3. Patients who have active bleeding
4. Judged by investigator not to be appropriate for inclusion in this study
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yusuke Kobayashi |
Organization
Yokosuka city hospital
Division name
Division of nephrology
Zip code
Address
1-3-2, Nagasaka, Yokosuka
TEL
046-856-3136
yusuke.kob@live.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yusuke Kobayashi |
Organization
Yokosuka city hospital
Division name
Division of nephrology
Zip code
Address
1-3-2, Nagasaka, Yokosuka
TEL
046-856-3136
Homepage URL
yusuke.kob@live.jp
Sponsor or person
Institute
Yokosuka city hostotai
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
| 2015 | Year | 06 | Month | 10 | 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
Open public recruiting
Date of protocol fixation
| 2015 | Year | 06 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 06 | Month | 10 | 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
| 2015 | Year | 06 | Month | 10 | Day |
Last modified on
| 2015 | Year | 06 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020682
