UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012986 |
|---|---|
| Receipt number | R000015168 |
| Scientific Title | The effect of potassium citrate on serum uric acid: a study of potassium dose and response relationship |
| Date of disclosure of the study information | 2014/01/28 |
| Last modified on | 2014/08/26 11:04:07 |
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Basic information
Public title
The effect of potassium citrate on serum uric acid: a study of potassium dose and response relationship
Acronym
The effect of potassium citrate on serum uric acid: a study of potassium dose and response relationship
Scientific Title
The effect of potassium citrate on serum uric acid: a study of potassium dose and response relationship
Scientific Title:Acronym
The effect of potassium citrate on serum uric acid: a study of potassium dose and response relationship
Region
| Japan |
Condition
Condition
Hyperuricemia
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine whether dose of potassium affects serum urate reducing effect of citric acid
Basic objectives2
Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
serum urate
Key secondary outcomes
urine pH
urate clearance
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Monopotassium Citrate 4.53g per day
Interventions/Control_2
Tripotassium Citrate monohydrate 6.53g per day
Interventions/Control_3
no citrate administration
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
| 40 | years-old | >= |
Gender
Male
Key inclusion criteria
1) A healthy subject who is able to understand the explanation of study and follow instructions given by investigators
2) A subjects who gives written informed consent before a screening test
Key exclusion criteria
1) A subject with clinical evidence or history of hepatic, renal, gastrointestinal, hematologic or other diseases that affect the result of this study and safety of subjects
2)A subject with history of allergies of citrate
3)A subject who takes drugs
4)A subject who is out of range of clinical acceptability in medical history and physical examination, and laboratory tests
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tsutomu Kotegawa |
Organization
Oita University Faculty of Medicine
Division name
Department of Clinical Pharmacology and Therapeutics
Zip code
Address
1-1 Idaigaoka Hasama-machi, Yufu 879-5593, Japan
TEL
097-586-5952
kotet@oita-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tsutomu Kotegawa |
Organization
Oita University Faculty of Medicine
Division name
Department of Clinical Pharmacology and Therapeutics
Zip code
Address
1-1 Idaigaoka Hasama-machi, Yufu 879-5593, Japan
TEL
097-586-5952
Homepage URL
kotet@oita-u.ac.jp
Sponsor or person
Institute
Dept. of Clinical Pharmacology and Therapeutics, Oita University Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
Oita University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
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
大分大学医学部附属病院総合臨床研究センター (General Clinical Research Center, Oita University Hospital)
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 01 | Month | 28 | 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
| 2013 | Year | 12 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 01 | Month | 28 | Day |
Last follow-up date
| 2014 | Year | 03 | Month | 25 | Day |
Date of closure to data entry
| 2014 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2014 | Year | 04 | Month | 30 | Day |
Date analysis concluded
| 2014 | Year | 05 | Month | 09 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 01 | Month | 28 | Day |
Last modified on
| 2014 | Year | 08 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015168
