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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000039034
Receipt No. R000044513
Scientific Title The impact of zinc levels on nutritional status in hemodialysis patients
Date of disclosure of the study information 2020/04/01
Last modified on 2020/06/30

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Basic information
Public title The impact of zinc levels on nutritional status
Acronym Zinc levels and nutrition
Scientific Title The impact of zinc levels on nutritional status in hemodialysis patients
Scientific Title:Acronym Zinc levels and nutritional status in hemodialysis patients
Region
Japan

Condition
Condition Zinc deficiency
Classification by specialty
Medicine in general
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the association between zinc levels and nutritional status
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Muscle mass, fat mass and bone mineral content at the beginning of study and after 12 months
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Taking zinc 25-100mg/day orally
Interventions/Control_2 Not taking zinc
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
85 years-old >=
Gender Male and Female
Key inclusion criteria Hemodialysis patients with zinc deficiency
Key exclusion criteria Hemodialysis patients without zinc deficiency
Target sample size 80

Research contact person
Name of lead principal investigator
1st name Hirotaka
Middle name
Last name Fukasawa
Organization Iwata City Hospital
Division name Renal Division
Zip code 438-0083
Address 512-3 Ohkubo, Iwata, Shizuoka
TEL 0538-38-5000
Email hfukasawaucsd@gmail.com

Public contact
Name of contact person
1st name Hirotaka
Middle name
Last name Fukasawa
Organization Iwata City Hospital
Division name Renal Division
Zip code 438-0083
Address 512-3 Ohkubo, Iwata, Shizuoka
TEL 0538-38-5000
Homepage URL
Email hfukasawaucsd@gmail.com

Sponsor
Institute Renal Division, Iwata City Hospital
Institute
Department

Funding Source
Organization Iwata City Hospital
Organization
Division
Category of Funding Organization Local Government
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Iwata City Hospital
Address 512-3 Ohkubo, Iwata, Shizuoka
Tel 0538-38-5000
Email hfukasawaucsd@gmail.com

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
2020 Year 04 Month 01 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 80
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
2018 Year 01 Month 01 Day
Date of IRB
2018 Year 11 Month 13 Day
Anticipated trial start date
2019 Year 01 Month 01 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
2021 Year 09 Month 30 Day
Date trial data considered complete
2022 Year 03 Month 31 Day
Date analysis concluded
2022 Year 09 Month 30 Day

Other
Other related information

Management information
Registered date
2019 Year 12 Month 30 Day
Last modified on
2020 Year 06 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044513

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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