UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015142 |
|---|---|
| Receipt number | R000017320 |
| Scientific Title | Reference Interval for Clearance and Excretion of Uric Acid in Japan |
| Date of disclosure of the study information | 2014/10/01 |
| Last modified on | 2017/03/14 14:33:58 |
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Basic information
Public title
Reference Interval for Clearance and Excretion of Uric Acid in Japan
Acronym
RICE-U
Scientific Title
Reference Interval for Clearance and Excretion of Uric Acid in Japan
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Hiroshi Tsutani |
Organization
National Hospital Organiation Awara Hospital
Division name
Directer
Zip code
Address
238-1 Kitagata, Awara, Fukui 910-4271, Japan
TEL
0776-79-1211
tsutani.hiroshi@awara-nho.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Junko Aoike |
Organization
National Hospital Organiation Awara Hospital
Division name
Division of Clinical Research
Zip code
Address
238-1 Kitagata, Awara, Fukui 910-4271, Japan
TEL
0776-79-1211
Homepage URL
401CRC@hosp.go.jp
Sponsor or person
Institute
National Hospital Organiation Awara Hospital
Institute
Department
Personal name
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)
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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 10 | 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
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
Completed
Date of protocol fixation
| 2014 | Year | 08 | Month | 01 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017320
