UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014413 |
|---|---|
| Receipt number | R000016768 |
| Scientific Title | Effects of krill oil on knee joint pain |
| Date of disclosure of the study information | 2014/07/15 |
| Last modified on | 2017/09/13 16:25:33 |
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Basic information
Public title
Effects of krill oil on knee joint pain
Acronym
Effects of krill oil on knee joint pain
Scientific Title
Effects of krill oil on knee joint pain
Scientific Title:Acronym
Effects of krill oil on knee joint pain
Region
| Japan |
Condition
Condition
Knee joint pain
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of a month of krill oil administration on knee joint pain.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Japanese Knee Osteoarthritis Measure (JCOM), The Japanese Orthopedic Association knee rating score (JOA score)
Key secondary outcomes
C-reactive protein, MMP-3, hyaluronic acid (HA), Range of motion (ROM) of the knee, etc.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Given krill oil supplement for 4 weeks.
Interventions/Control_2
Given placebo (control group) supplement for 4 weeks.
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
Outpatient who has knee joint pain.
Key exclusion criteria
1) a patient treated with biological agent(s)
2) a patient judged inadequate to enter the trial by orthopedist
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshio Suzuki |
Organization
Juntendo University
Division name
Graduate School of Health & Sports Science
Zip code
Address
1-1, Hiraga-gakuendai, Inzai, Chiba
TEL
0476-98-1001
yssuzuki@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshio Suzuki |
Organization
Juntendo University
Division name
Graduate School of Health & Sports Science
Zip code
Address
1-1, Hiraga-gakuendai, Inzai, Chiba
TEL
0476-98-1001
Homepage URL
yssuzuki@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University, Graduate School of Health & Sports Science
Institute
Department
Personal name
Funding Source
Organization
Sunsho Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
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
福島整形外科病院（栃木県）/ Fukushima Orthopedic Clinic (Tochigi)
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 07 | 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
Both the placebo and krill oil groups showed significant improvements in the questions in the JKOM and JOA questionnaires after administration. After the intervention, krill oil group showed more improvements than placebo group in two questions regarding the pain and stiffness in knees in JKOM. Controlling for age, sex, weight, and smoking and drinking habits, krill oil significantly mitigated knee pain in sleeping (P < 0.001), standing (P < 0.001) and the range of motion of both right and left knees (both P = 0.011) compared to placebo. Krill oil administration raised plasma EPA (P = 0.048) and EPA/AA ratio (P = 0.003).
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
Main results already published
Date of protocol fixation
| 2014 | Year | 06 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 04 | Month | 20 | Day |
Date of closure to data entry
| 2015 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2015 | Year | 07 | Month | 30 | Day |
Date analysis concluded
| 2015 | Year | 11 | Month | 30 | Day |
Other
Other related information
http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0162769
Management information
Registered date
| 2014 | Year | 06 | Month | 29 | Day |
Last modified on
| 2017 | Year | 09 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016768
| 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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