UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of the effect of N-acetyl-glucosamine administration on biomarkers for cartilage metabolism
Title of the study (Brief title)	Evaluation of the effect of N-acetyl-glucosamine administration on biomarkers for cartilage metabolism
Region	Japan

Condition
Condition	Japanese adult without clinical and radiographic evidence of knee osteoarthritis
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effect of N-acetyl-glucosamine on the cartilage metabolism and safety
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	change in C2C/PIICP (weeks 16 during the intervention) chnge in C2C/PIICP (weeks 8 and 12 during the intervention, weeks 8 after intervention)
Key secondary outcomes	change in C2C (weeks 8, 12 and 16 during the intervention, weeks 8 after intervention) change in PIICP (weeks 8, 12 and 16 during the intervention, weeks 8 after intervention)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	NO
Dynamic allocation	NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	N-acetyl-glucosamine (500 mg/day, weeks 16 during the intervention)
Interventions/Control_2	Placebo (500 mg/day, weeks 16 during the intervention)
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	40 years-old <=
Age-upper limit	74 years-old >=
Gender	Male and Female
Key inclusion criteria	Japanese adult (aged 40-74) without clinical and radiographic evidence of knee osteoarthritis
Key exclusion criteria	1.Subjects with gout or rheumatoid arthritis 2.Subjects with surgical treatment of joint performed or its necessity 3.Subjects with routine use of health foods which are good for bone or joint 4.Subjects with the presence of any clinically significant conditions judged by the medical investigator to preclude the subject's participation in the study
Target sample size	120

Research contact person
Name of lead principal investigator	Mihoko Kurokawa
Organization	Q' SAI CO.,LTD.
Division name	Research Department
Address	1-7-16 Kusagae, Chuo-ku, Fukuoka-shi, JAPAN
TEL	092-724-0855
Email	kurokawa@kyusai.co.jp

Public contact
Name of contact person	Takashi Nakagawa
Organization	TTC Co.,Ltd.
Division name	Clinical Research Planning Department
Address	1-20-2, Ebisunishi, Shibuya-ku, Tokyo
TEL	03-5459-5329
Homepage URL
Email	t.nakagawa@ttc-tokyo.co.jp

Sponsor
Institute	Q' SAI CO.,LTD
Institute
Department

Funding Source
Organization	Q' SAI 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

Other administrative information
Date of disclosure of the study information	2017 Year 09 Month 30 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 01 Month 14 Day
Anticipated trial start date	2016 Year 01 Month 16 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 01 Month 15 Day
Last modified on	2017 Year 03 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023769