UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036716 |
|---|---|
| Receipt number | R000041834 |
| Scientific Title | Relationship between lymphocyte count, serum zinc and copper during zinc acetate administration in hemodialysis patients with hypozinemia . |
| Date of disclosure of the study information | 2019/06/01 |
| Last modified on | 2019/05/12 00:15:56 |
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Basic information
Public title
Relationship between lymphocyte count, serum zinc and copper during zinc acetate administration in hemodialysis patients with hypozinemia
.
Acronym
Relationship between lymphocyte count, serum zinc and copper
Scientific Title
Relationship between lymphocyte count, serum zinc and copper during zinc acetate administration in hemodialysis patients with hypozinemia
.
Scientific Title:Acronym
Relationship between lymphocyte count, serum zinc and copper
Region
| Japan |
Condition
Condition
Lymphopenia in hemodialysis patients
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Clinical trial whether zinc acetate administration improves lymphopenia
Basic objectives2
Others
Basic objectives -Others
Examination of the change of lymphocyte count and serum zinc and copper level by zinc acetate administration.
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Increased number of lymphocytes after 12 months by zinc acetate administration
Key secondary outcomes
To evaluate the safety of zinc acetate administration from clinical adverse events and serum zinc and copper levels
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Administer 100mg of zinc acetate daily for 12 months to hemodialysis patients with hypozinemia and lymphopenia
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Hemodialysis patients with serum zinc level less than 65microg/dl before the study
Key exclusion criteria
Patients who did not get consent for the trial
Target sample size
23
Research contact person
Name of lead principal investigator
| 1st name | RYOICHI |
| Middle name | |
| Last name | MIYAZAKI |
Organization
Fujita Memorial Hospital
Division name
Internal Medicine
Zip code
910-0004
Address
4-15-7, Houei, Fukui City, Japan
TEL
0776-21-1277
ryoichi@mitene.or.jp
Public contact
Name of contact person
| 1st name | RYOICHI |
| Middle name | |
| Last name | MIYAZAKI |
Organization
Fujita Memorial Hospital
Division name
Internal Medicine
Zip code
910-0004
Address
4-15-7, Houei, Fukui City, Japan
TEL
0776-21-1277
Homepage URL
ryoichi@mitene.or.jp
Sponsor or person
Institute
Fujita Memorial Hospital
Institute
Department
Personal name
Funding Source
Organization
Fujita Memorial Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
Fujita Memorial Hospital
Address
4-15-7, Houei, Fukui City, Japan
Tel
0776-21-1277
ryoichi@mitene.or.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
藤田記念病院
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 06 | Month | 01 | 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
23
Results
Examination end
Results date posted
| 2019 | Year | 05 | Month | 12 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
Analysis delay
Date of the first journal publication of results
| 2020 | Year | 12 | Month | 01 | Day |
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 | 06 | Month | 15 | Day |
Date of IRB
| 2017 | Year | 08 | Month | 07 | Day |
Anticipated trial start date
| 2017 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 09 | Month | 15 | Day |
Date of closure to data entry
| 2018 | Year | 10 | Month | 01 | Day |
Date trial data considered complete
| 2018 | Year | 10 | Month | 30 | Day |
Date analysis concluded
| 2019 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 05 | Month | 12 | Day |
Last modified on
| 2019 | Year | 05 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041834
| Research Plan | |
|---|---|
| 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 |
