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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002348
Receipt No. R000002878
Scientific Title Effect of Citrus sphaerocarpa juice on serum urate and urinary pH: comparative study with potassium and sodium citrate (Uralyt-U)
Date of disclosure of the study information 2009/08/20
Last modified on 2012/12/20

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Basic information
Public title Effect of Citrus sphaerocarpa juice on serum urate and urinary pH: comparative study with potassium and sodium citrate (Uralyt-U)
Acronym Effect of Citrus sphaerocarpa juice on serum urate and urinary pH
Scientific Title Effect of Citrus sphaerocarpa juice on serum urate and urinary pH: comparative study with potassium and sodium citrate (Uralyt-U)
Scientific Title:Acronym Effect of Citrus sphaerocarpa juice on serum urate and urinary pH
Region
Japan

Condition
Condition healthy volunteers
Classification by specialty
Not applicable
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the effect of Citrus sphaerocarpa juice on serum urate and urinary pH by comparison with potassium and sodium citrate (Uralyt-U)
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes serum urate
Urinary pH
Key secondary outcomes 1)serum BUN, creatinine, citrate, minerals
2)urinary volume, BUN, creatinine, urate, citrate, mineals

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment No need to know

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine Food
Interventions/Control_1 1)Uralyt-U, 2)Citrus sphaerocarpa, 3)mineral water
Interventions/Control_2 1)Citrus sphaerocarpa, 2)mineral water, 3)Uralyt-U
Interventions/Control_3 1)mineral water, 2)Uralyt-U, 3)Citrus sphaerocarpa
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 and Female
Key inclusion criteria 1)written informed consent before the study
2)volunteers ascertained to be healthy by a medical history, a physical examination, electrocardiogram, whole blood cell counts, serum chemical analysis and urinalysis.
Key exclusion criteria 1)smokers
2)pregnant women
3)nursing women
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 Clinical Pharmacology and Therapeutics
Zip code
Address Idaigaoka1-1, Hasama-machi, Yufu, Oita 879-5593
TEL 097-586-5952
Email

Public contact
Name of contact person
1st name
Middle name
Last name Tsutomu Kotegawa
Organization Oita University Faculty of Medicine
Division name Clinical Pharmacology and Therapeutics
Zip code
Address Idaigaoka1-1, Hasama-machi, Yufu, Oita 879-5593
TEL 097-586-5952
Homepage URL
Email kotet@med.oita-u.ac.jp

Sponsor
Institute Dept. of Clinical Pharmacology and Therapeutics, Oita University Faculty of Medicine
Institute
Department

Funding Source
Organization Sangyousouzoukikou
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor None
Name of secondary funder(s) None

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2009 Year 08 Month 20 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
2009 Year 07 Month 18 Day
Date of IRB
Anticipated trial start date
2009 Year 08 Month 01 Day
Last follow-up date
2010 Year 04 Month 01 Day
Date of closure to data entry
2010 Year 04 Month 01 Day
Date trial data considered complete
2010 Year 05 Month 01 Day
Date analysis concluded
2010 Year 05 Month 01 Day

Other
Other related information

Management information
Registered date
2009 Year 08 Month 18 Day
Last modified on
2012 Year 12 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002878

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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