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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000031655
Receipt No. 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 2019/09/09

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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
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 Open public recruiting
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
2019 Year 09 Month 09 Day


Link to view the page
URL(English) https://upload.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


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