UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000054157 |
|---|---|
| Receipt number | R000061845 |
| Scientific Title | Investigation of the Effect of Urine Preservative Addition as an Alternative Method to Hydrochloric Acid Addition in Urinary Biochemical Index Concentration Measurement |
| Date of disclosure of the study information | 2024/04/16 |
| Last modified on | 2024/04/15 16:44:54 |
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Basic information
Public title
Consideration of urine test by adding urine preservative as a substitute for hydrochloric acid
Acronym
Measurement of urine biochemical indicators using a new urine preservative
Scientific Title
Investigation of the Effect of Urine Preservative Addition as an Alternative Method to Hydrochloric Acid Addition in Urinary Biochemical Index Concentration Measurement
Scientific Title:Acronym
Measurement of urine biochemical indicators using a new urine preservative
Region
| Japan |
Condition
Condition
Ca metabolic disorders such as primary hyperparathyroidism
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of a new urine preservative on the measurement of urine biochemical indicators, and to determine whether it can be used clinically as a substitute for hydrochloric acid, which requires careful management and handling.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation between urinary biochemical indicators when using hydrochloric acid and urinary biochemical indicators when using a new urine preservative
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Have an endocrine metabolic disease that requires measurement of urinary biochemical indicators using collected urine.
2) Age at the time of consent is 20 years or older.
3) Written consent has been obtained from the individual to participate in the study.
Key exclusion criteria
Renal failure with eGFR less than 30 ml/min/1.73m2
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Masakazu |
| Middle name | |
| Last name | Notsu |
Organization
Shimane University School of Medicine,
Division name
Internal Medicine 1
Zip code
693-8501
Address
Shimane, Izumo city, Enya-cho, 89-1
TEL
0853-20-2183
mnotsu25@med.shimane-u.ac.jp
Public contact
Name of contact person
| 1st name | Masakazu |
| Middle name | |
| Last name | Notsu |
Organization
Shimane University School of Medicine
Division name
Internal Medicine 1
Zip code
693-8501
Address
Shimane, Izumo city, Enya-cho, 89-1
TEL
0853-20-2183
Homepage URL
mnotsu25@med.shimane-u.ac.jp
Sponsor or person
Institute
Shimane University
Institute
Department
Personal name
Funding Source
Organization
Shimane University
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
Shimane University School of Medicine Medical Research Ethics Committee
Address
Shimane, Izumo city, Enya-cho, 89-1
Tel
+91-853-20-2183
kenkyu@med.shimane-u.ac.jp
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
| 2024 | Year | 04 | Month | 16 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 04 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 04 | Month | 17 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observation items
1) Urinary Ca excretion amount
2) Urinary P excretion amount
3) Urinary Cr excretion/urinary Na excretion (measured using normal urine without additives)
4) Urine volume
Management information
Registered date
| 2024 | Year | 04 | Month | 15 | Day |
Last modified on
| 2024 | Year | 04 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061845
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
