UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of krill oil on knee joint pain
Title of the study (Brief title)	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	Yoshio Suzuki
Organization	Juntendo University
Division name	Graduate School of Health & Sports Science
Address	1-1, Hiraga-gakuendai, Inzai, Chiba
TEL	0476-98-1001
Email	yssuzuki@juntendo.ac.jp

Public contact
Name of contact person	Yoshio Suzuki
Organization	Juntendo University
Division name	Graduate School of Health & Sports Science
Address	1-1, Hiraga-gakuendai, Inzai, Chiba
TEL	0476-98-1001
Homepage URL
Email	yssuzuki@juntendo.ac.jp

Sponsor
Institute	Juntendo University, Graduate School of Health & Sports Science
Institute
Department

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)

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

Progress
Recruitment status	Main results already published
Date of protocol fixation	2014 Year 06 Month 12 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
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).
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016768