UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042511 |
|---|---|
| Receipt number | R000048109 |
| Scientific Title | Usefulness of zinc preparation administration in zinc deficiency dialysis patients |
| Date of disclosure of the study information | 2021/06/30 |
| Last modified on | 2020/11/20 12:22:30 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
r.hatonari@khg.or.jp
Sponsor or person
Institute
Kawashima Hospital Group
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048109
