UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031655
Receipt number R000035390
Scientific Title Examination of the effect of improving anemia / taste disorder by administration of zinc supplementation to chronic kidney disease exhibiting hypozincemia
Date of disclosure of the study information 2018/03/12
Last modified on 2021/09/10 20:24:15

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Basic information

Public title

Examination of the effect of improving anemia / taste disorder by administration of zinc supplementation to chronic kidney disease exhibiting hypozincemia

Acronym

Effect of zinc supplementation in patients with chronic kidney disease

Scientific Title

Examination of the effect of improving anemia / taste disorder by administration of zinc supplementation to chronic kidney disease exhibiting hypozincemia

Scientific Title:Acronym

Effect of zinc supplementation in patients with chronic kidney disease

Region

Japan


Condition

Condition

chronic kidney disease
Hypozincemia

Classification by specialty

Nephrology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To clarify the effect of zinc supplementation on anemia and taste disorder in patients with chronic kidney disease with hypozincemia

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase



Assessment

Primary outcomes

anemia

Changes in subjective symptoms of taste disorder

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

No treatment

Stratification

NO

Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

6 months
Zn Tablet 50mg/day
Everyday,
Drug will be increased or decreased depending
on blood zinc concentration

Interventions/Control_2

6 months
No medical intervention

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

90 years-old >=

Gender

Male and Female

Key inclusion criteria

Patients with chronic kidney disease visiting our hospital (CKD Stage1-2, n =100; Stag3, n =100; Stage4, n =100; Stage5, n =100; Stage 5D, n =100)

Key exclusion criteria

1. We can not obtain consent from patients and their families
2. When the patient's own cognitive decline is strong and it is judged that it is impossible to properly continue the examination
3. Patients who are judged inappropriate as the subject by the research director

Target sample size

500


Research contact person

Name of lead principal investigator

1st name Daisuke
Middle name
Last name Sato

Organization

Juntendo University

Division name

Division of Nephrolog

Zip code

1130033

Address

3-1-1 Hongo Bunkyo-ku Tokyo

TEL

03-3813-3111

Email

d-sato@juntendo.ac.jp


Public contact

Name of contact person

1st name Daisuke
Middle name
Last name Sato

Organization

Juntendo University

Division name

Division of Nephrology

Zip code

1130033

Address

3-1-1 Hongo Bunkyo-ku Tokyo

TEL

03-3813-3111

Homepage URL


Email

d-sato@juntendo.ac.jp


Sponsor or person

Institute

Juntendo University

Institute

Department

Personal name



Funding Source

Organization

self funding

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

Ethics committee of Juntendo Hospital

Address

2-1-1 Hongo Bunkyo-ku

Tel

03-3813-3111

Email

kenkyu5858@juntendo.ac.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



Other administrative information

Date of disclosure of the study information

2018 Year 03 Month 12 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


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

Suspended

Date of protocol fixation

2017 Year 11 Month 21 Day

Date of IRB

2017 Year 11 Month 24 Day

Anticipated trial start date

2017 Year 12 Month 01 Day

Last follow-up date

2020 Year 09 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 03 Month 09 Day

Last modified on

2021 Year 09 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035390


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name