UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046906 |
|---|---|
| Receipt number | R000053515 |
| Scientific Title | Association between Vitamin D status and COVID-19 antibody titer in patients with hemodialysis |
| Date of disclosure of the study information | 2022/02/14 |
| Last modified on | 2024/02/28 17:31:41 |
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Basic information
Public title
Association between Vitamin D status and COVID-19 antibody titer in patients with hemodialysis
Acronym
Vitamin D and COVID-19 antibody titer in HD patients
Scientific Title
Association between Vitamin D status and COVID-19 antibody titer in patients with hemodialysis
Scientific Title:Acronym
Association between Vitamin D status and COVID-19 antibody titer in patients with hemodialysis
Region
| Japan |
Condition
Condition
COVID-19 infection
Classification by specialty
| Nephrology | Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the association between Vitamin D status and COVID-19 antibody titer by vaccination.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
COVID-19 antibody titer
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Vaccine |
Interventions/Control_1
COVID-19 vaccine (BNT162b2)
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The participants are older than 20 years of age, and regularly received thrice-weekly hemodialysis. In addition, the participants are those who obtained written, informed consent.
Key exclusion criteria
This study exclude patients who do not have enough judgment ability, can not write questionnaire, and are current illness worsens.
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Nakashima |
| Middle name | |
| Last name | Akio |
Organization
Jikei University School of Medicine
Division name
Division of Nephrology and Hypertension, Department of Internal Medicine
Zip code
105-8461
Address
3-25-8 Nishi-Shimbashi, Minato-ku, Tokyo
TEL
03-3411-1111
a-nakashima@jikei.ac.jp
Public contact
Name of contact person
| 1st name | Nakashima |
| Middle name | |
| Last name | Akio |
Organization
Jikei University School of Medicine
Division name
Division of Nephrology and Hypertension, Department of Internal Medicine
Zip code
105-8461
Address
3-25-8 Nishi-Shimbashi, Minato-ku, Tokyo
TEL
03-3411-1111
Homepage URL
a-nakashima@jikei.ac.jp
Sponsor or person
Institute
Jikei University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Jikei University School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Jikei University School of Medicine
Address
Jikei University School of Medicine
Tel
03-3433-1111
rinri@jikei.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
| 2022 | Year | 02 | Month | 14 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
418
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
Completed
Date of protocol fixation
| 2021 | Year | 12 | Month | 24 | Day |
Date of IRB
| 2021 | Year | 12 | Month | 24 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 31 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 02 | Month | 14 | Day |
Last modified on
| 2024 | Year | 02 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053515
