UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041366 |
|---|---|
| Receipt number | R000047228 |
| Scientific Title | Association between blood metal and dry skin in hemodialysis patients |
| Date of disclosure of the study information | 2020/08/09 |
| Last modified on | 2020/08/09 16:57:48 |
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Basic information
Public title
Association between blood metal and dry skin in hemodialysis patients
Acronym
Association between blood metal and dry skin in hemodialysis patients
Scientific Title
Association between blood metal and dry skin in hemodialysis patients
Scientific Title:Acronym
Association between blood metal and dry skin in hemodialysis patients
Region
| Japan |
Condition
Condition
Hemodialysis
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We measured the blood metal concentration in hemodialysis patients, and examined the relationship with pruritus and skin condition.
Basic objectives2
Others
Basic objectives -Others
The purpose of this study is to examine the relationship between metal in the blood and pruritus and lead to the development of new treatment.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
TEWL
Shirotori's criteria
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Hemodialysis patients
Key exclusion criteria
Patients with wounds or obvious skin lesions on the forearm or the area to be observed, and patients taking zinc preparations or supplements.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Kazuya |
| Middle name | |
| Last name | Ooi |
Organization
Suzuka University of Medical Science
Division name
Laboratory of Clinical Pharmacology, Graduate School of Pharmaceutical Sciences
Zip code
513-8670
Address
3500-3 Minamitamagaki, Suzuka, Mie
TEL
+81-59-340-0571
zooi@suzuka-u.ac.jp
Public contact
Name of contact person
| 1st name | Masataka |
| Middle name | |
| Last name | Deguchi |
Organization
Suzuka University of Medical Science
Division name
Laboratory of Clinical Pharmacology, Graduate School of Pharmaceutical Sciences
Zip code
513-8670
Address
3500-3 Minamitamagaki, Suzuka, Mie
TEL
059-340-0550
Homepage URL
degdeg2003jp@gmail.com
Sponsor or person
Institute
Suzuka University of Medical Science
Institute
Department
Personal name
Funding Source
Organization
Suzuka University of Medical Science
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
Suzuka University of Medical Science Clinical Research Ethics Review Board
Address
3500-3 Minamitamagaki, Suzuka, Mie
Tel
059-340-0550
homepage@suzuka-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
| 2020 | Year | 08 | Month | 09 | 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
56
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
| 2017 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 06 | Month | 29 | Day |
Anticipated trial start date
| 2017 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Blood collection was performed at the start of hemodialysis in order to measure the concentrations of metal (Zn, Cu, Fe, Mn, Mg, Ca) in serum and whole blood.
TEWL was measured 3 times each within 15 minutes from the start of hemodialysis on the inner side of the forearm on the non-shunt limb side.
Management information
Registered date
| 2020 | Year | 08 | Month | 09 | Day |
Last modified on
| 2020 | Year | 08 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047228
| 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 |
