UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030521 |
|---|---|
| Receipt number | R000034844 |
| Scientific Title | Evaluation of PT-INR after eating reduced vitamin K2 Natto in patients who has warfarin treatment |
| Date of disclosure of the study information | 2018/02/01 |
| Last modified on | 2019/06/24 10:08:41 |
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Basic information
Public title
Evaluation of PT-INR after eating reduced vitamin K2 Natto in patients who has warfarin treatment
Acronym
PT-INR and reduced vitamin K2 Natto
Scientific Title
Evaluation of PT-INR after eating reduced vitamin K2 Natto in patients who has warfarin treatment
Scientific Title:Acronym
PT-INR and reduced vitamin K2 Natto
Region
| Japan |
Condition
Condition
Warfarin treated patients
Classification by specialty
| Cardiology | Vascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the safety of newly developed low vitamin K2 Natto by looking at PT-INR values in warfarin treated patients.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
change of PT-INR will be evaluated before and after eating low vitamin K2 Natto for 7 days.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Warfarin treated patients who eat low vitamin K2 Natto for 7 days. When 10g is acceptable, same patients will take 20g Natto.
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
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patient who has bioprosthetic valve for valve replacement. PT-INR needs to be stable.
Key exclusion criteria
mechanical valve replacement. thrombosis history.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Yuji |
| Middle name | |
| Last name | Hiramatsu |
Organization
University of Tsukuba
Division name
Cardiovascular Surgery
Zip code
305-8575
Address
1-1-1 Tennodai, Tsukuba, Ibaraki
TEL
029-853-3210
yuji3@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Yuji |
| Middle name | |
| Last name | Hiramatsu |
Organization
University of Tsukuba
Division name
Cradiovascular Surgery
Zip code
305-8575
Address
1-1-1 Tennodai, Tsukuba, Ibaraki
TEL
029-853-3210
Homepage URL
yuji3@md.tsukuba.ac.jp
Sponsor or person
Institute
Department of Cardiovascular Surgery, University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Takano Foods Co. Ltd
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB, University of Tsukuba HOspital
Address
2-1-1 Amakubo, Tsukuba, Ibaraki
Tel
029-853-3210
t-credo.adm@un.tsukuba.ac.jp
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
筑波大学附属病院（茨城県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 02 | 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
20
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
No longer recruiting
Date of protocol fixation
| 2017 | Year | 12 | Month | 22 | Day |
Date of IRB
| 2018 | Year | 01 | Month | 22 | Day |
Anticipated trial start date
| 2018 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 12 | Month | 22 | Day |
Last modified on
| 2019 | Year | 06 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034844
| 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 |
