UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Reference Interval for Clearance and Excretion of Uric Acid in Japan
Title of the study (Brief title)	RICE-U
Region	Japan

Condition
Condition	Hyperuricemia
Classification by specialty	Medicine in general Endocrinology and Metabolism Nephrology Clinical immunology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify reference interval of urinary uric acid clearance test in Japanese adults
Basic objectives2	Others
Basic objectives -Others	Reference interval
Trial characteristics_1	Others
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	60 min uric acid excretion, uric acid clearance
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	65 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Indoor workers 2) Age between 20 y.o. and 65 y.o 3) Consent in writing by the person
Key exclusion criteria	1) People who smoked 20 cigarettes or more per day 2) Who are receiving medication on a regular basis 3) People of women within one year after delivery or during pregnancy 4) People carrier hepatitis B virus, C hepatitis virus, human immunodeficiency virus 5) People who are planning or its received hospital treatment, surgery for acute disease within two weeks before the 60-minute method uric acid clearance inspection date 6) People who are scheduled to extreme exercise, muscle exertion of about can not talk during an activity for three days in front of the 60-minute method uric acid clearance inspection date 7)People who are scheduled overwork that prevents sleep time in three days in front of the 60-minute method uric acid clearance examination date, excessive stress, food and drink excessive 8) People you are planning that, or was taking drugs affecting the serum uric acid level in two weeks in front of the 60-minute method uric acid clearance inspection date
Target sample size	990

Research contact person
Name of lead principal investigator	Hiroshi Tsutani
Organization	National Hospital Organiation Awara Hospital
Division name	Directer
Address	238-1 Kitagata, Awara, Fukui 910-4271, Japan
TEL	0776-79-1211
Email	tsutani.hiroshi@awara-nho.jp

Public contact
Name of contact person	Junko Aoike
Organization	National Hospital Organiation Awara Hospital
Division name	Division of Clinical Research
Address	238-1 Kitagata, Awara, Fukui 910-4271, Japan
TEL	0776-79-1211
Homepage URL
Email	401CRC@hosp.go.jp

Sponsor
Institute	National Hospital Organiation Awara Hospital
Institute
Department

Funding Source
Organization	National Hospital Organiation (NHO) multi-center clinical studies for evidence-based medicine
Organization
Division
Category of Funding Organization	Other
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	2014 Year 10 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 08 Month 01 Day
Anticipated trial start date	2014 Year 10 Month 01 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	Prospective observational study

Management information
Registered date	2014 Year 09 Month 12 Day
Last modified on	2017 Year 03 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017320