UMIN-CTR Clinical Trial

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
Last 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
1st 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