UMIN-CTR Clinical Trial

Basic information
Public title	Usefulness of zinc preparation administration in zinc deficiency dialysis patients
Acronym	Usefulness of zinc preparation administration in zinc deficiency dialysis patients
Scientific Title	Usefulness of zinc preparation administration in zinc deficiency dialysis patients
Scientific Title:Acronym	Usefulness of zinc preparation administration in zinc deficiency dialysis patients
Region	Japan

Condition
Condition	Zinc deficiency Latent zinc deficiency
Classification by specialty	Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	At our hospital, zinc acetate hydrate preparation, which is a therapeutic drug for zinc deficiency, is not adopted in the hospital, but polar prezinc orally disintegrating tablets are adopted. As zinc, zinc acetate hydrate preparations can be administered up to 150 mg / day, while poraprezinc orally disintegrating tablets can only be administered up to 34 mg / day. Since active solute removal is performed under the OHDF treatment conditions of this hospital, the dose of ESA preparation is reduced and anemia is improved in OHDF patients and patients who administer poraprezinc orally disintegrating tablets, or administration of poraprezinc orally disintegrating tablets. Considering the effects of the amount and iron-containing preparations, we will compare and examine each albumin leakage amount under dialysis treatment conditions.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	Serum zinc concentration ESA dose Hb Albumin leakage
Key secondary outcomes	age Dialysis history Dialysis conditions Dialysate TSAT Ferritin Fedin administration period Ferromia oral dose Riona oral dose Pettle dose Total zinc dose TP Correction Ca P PTH K Mg Kt/V Beta 2 microglobulin HS-CRP Cr index Serum Alb nPCR ERI Lipid

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	Patients with deficiency or latent deficiency measured for serum zinc levels
Key exclusion criteria	Patients receiving zinc preparations before the start of evaluation Patients who discontinued administration after exceeding the doctor's judgment and serum zinc concentration standard value Patients receiving more than the package insert of Polarezinc Orally Disintegrating Tablets
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Ryosuke Middle name Last name Hatonari
Organization	Kawashima Hospital Group
Division name	Faculty of Clinical Engineering
Zip code	770-0011
Address	6-1 Kitasako 1bancho, Tokushima City, Tokushima Prefecture
TEL	088-634-0200
Email	r.hatonari@khg.or.jp

Public contact
Name of contact person	1st name Ryosuke Middle name Last name Hatonari
Organization	Kawashima Hospital Group
Division name	Faculty of Clinical Engineering
Zip code	770-0011
Address	1-39 Kitasako 1bancho, Tokushima City, Tokushima Prefecture
TEL	088-631-0110
Homepage URL
Email	r.hatonari@khg.or.jp

Sponsor
Institute	Kawashima Hospital Group
Institute
Department

Funding Source
Organization	None
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	Kawashima Hospital Group
Address	1-39 Kitasako 1bancho, Tokushima City, Tokushima Prefecture
Tel	088-631-0110
Email	r.hatonari@khg.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	川島透析クリニック(徳島県)

Other administrative information
Date of disclosure of the study information	2021 Year 06 Month 30 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	100
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	No longer recruiting
Date of protocol fixation	2020 Year 07 Month 14 Day
Date of IRB	2020 Year 07 Month 21 Day
Anticipated trial start date	2020 Year 10 Month 19 Day
Last follow-up date	2021 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Zinc deficiency was suspected in a patient undergoing OHDF at our hospital, and blood zinc concentration was measured from January 2017 to May 2020. Zinc deficiency and latent zinc deficiency were diagnosed as dysgeusia. Patients who received internally disintegrating tablets will be evaluated before zinc administration, 6 months after administration, and 1 year after administration.

Management information
Registered date	2020 Year 11 Month 20 Day
Last modified on	2020 Year 11 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048109