UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004637 |
|---|---|
| Receipt number | R000005534 |
| Scientific Title | Comparison of serum uric acid levels in Rotavirus gastroenteritis and in non-Rotavirus gastroenteritis |
| Date of disclosure of the study information | 2010/12/01 |
| Last modified on | 2016/07/22 17:53:40 |
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Basic information
Public title
Comparison of serum uric acid levels in Rotavirus gastroenteritis and in
non-Rotavirus gastroenteritis
Acronym
RAGE study
Scientific Title
Comparison of serum uric acid levels in Rotavirus gastroenteritis and in
non-Rotavirus gastroenteritis
Scientific Title:Acronym
RAGE study
Region
| Japan |
Condition
Condition
Acute gastroenteritis
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine mechanisms of the serum uric acid level elevation in Rotavirus gastroenteritis
Basic objectives2
Others
Basic objectives -Others
Comparison of serum uric acid levels in Rotavirus gastroenteritis and in
non-Rotavirus gastroenteritis
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
serum uric acid level
weight change from pre-to post-rehydration
Key secondary outcomes
Ht,BUN,Cre,electrolyte
blood gas analysis
urine specific gravity
urine-sodium ketone body fraction
Fractional excretion of urate
Urinary beta-2 microglobulins
N-acetyl-B-glucosaminidase
Duration of symptoms before admission
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
| 1 | months-old | <= |
Age-upper limit
| 72 | months-old | > |
Gender
Male and Female
Key inclusion criteria
1.clinically diagnosed as acute
gastroenteritis
2.one month to six years old
3.hospitalization is necessary for treatment
Key exclusion criteria
1.a chronic disease
(cardiovascular disease,
renal disease, malignancy,
endocrine disease, metabolic disease,
immune deficiency disease,
chromosomal disorder,
neuromuscular disease)
2.medication that affects uric acid level (diuretic, uric acid synthesis inhibitor, uricosuric drug)
3.symptoms over eight days
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yukihiro Hasegawa |
Organization
Tokyo Metropolitan Children's medical center
Division name
general pediatrics
Zip code
Address
2-8-29 Musashidai Fuchu-shi Tokyo
TEL
042-300-5111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Tokyo Metropolitan Children's medical center
Division name
general pediatrics
Zip code
Address
2-8-29 Musashidai Fuchu-shi Tokyo
TEL
042-300-5111
Homepage URL
Sponsor or person
Institute
Tokyo Metropolitan Children's medical center
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
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
東京都立小児総合医療センター Tokyo Metropolitan Children's medical center
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 12 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2010 | Year | 11 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 12 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
| 2015 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2016 | Year | 06 | Month | 30 | Day |
Other
Other related information
prospective study
complete survey
the correlation of the serum uric acid levels with dehydration severity
Management information
Registered date
| 2010 | Year | 11 | Month | 30 | Day |
Last modified on
| 2016 | Year | 07 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005534
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
