UMIN-CTR Clinical Trial

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
Institute	Juntendo University
Institute
Department

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000035390