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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000036716
Receipt No. 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

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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
Email 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
Email ryoichi@mitene.or.jp

Sponsor
Institute Fujita Memorial Hospital
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041834

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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