UMIN-CTR Clinical Trial

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

Zinc deficiency
Latent zinc deficiency

Classification by specialty

Nephrology

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Kawashima Hospital Group

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

川島透析クリニック(徳島県)

Date of disclosure of the study information

2021

Year

06

Month

30

Day

URL releasing protocol

Publication of results

Partially published

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

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 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.

Registered date

2020

Year

11

Month

20

Day

Last modified on

2020

Year

11

Month

20

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048109