UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037853 |
|---|---|
| Receipt number | R000043155 |
| Scientific Title | Investigation on the management of hypocalcemia induced by citric acid during plasmapheresis/plateletpheresis, through analysis of the serum kinetics of ionized calcium |
| Date of disclosure of the study information | 2019/09/02 |
| Last modified on | 2021/03/09 11:45:19 |
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Basic information
Public title
Investigation on the management of
hypocalcemia induced by citric acid
during plasmapheresis/plateletpheresis,
through analysis of the serum kinetics
of ionized calcium
Acronym
Investigation on the management of
hypocalcemia induced by citric acid
during plasmapheresis/plateletpheresis,
through analysis of the serum kinetics
of ionized calcium
Scientific Title
Investigation on the management of
hypocalcemia induced by citric acid
during plasmapheresis/plateletpheresis,
through analysis of the serum kinetics
of ionized calcium
Scientific Title:Acronym
Investigation on the management of
hypocalcemia induced by citric acid
during plasmapheresis/plateletpheresis,
through analysis of the serum kinetics
of ionized calcium
Region
| Japan |
Condition
Condition
No
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1.The effectiveness of calcium-ion containing beverage and the calcium-ion rich wafer in preventing hypocalcemia induced by citric acid will be investigated by measuring the serum levels of ionized calcium and observing for the presence or absence of symptoms
2.The changes in the serum ionized calcium levels will be evaluated according to the blood donors' features, in an attempt to implement more effective preventive measures
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Serum ionized calcium levels
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
6
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Duration:single dose
Test material:
A:500ml sports drink without calcium
B:200ml of calcium-ion containing beverage
C:3 pieces of calcium-ion rich wafer(1020mg)
Administration:Administer the test material 30 minutes before blood collection.
[1]
Administer the test material A.
[2]
A more than two weeks interval between donations is required.
[3]
Administer the test material B.
[4]
A more than two weeks interval between donations is required.
[5]
Administer the test material C.
Interventions/Control_2
Duration:same as above
Test material:same as above
Administration:same as above
[1]
Administer the test material A.
[2]
A more than two weeks interval between donations is required.
[3]
Administer the test material C.
[4]
A more than two weeks interval between donations is required.
[5]
Administer the test material B.
Interventions/Control_3
Duration:same as above
Test material:same as above
Administration:same as above
[1]
Administer the test material B.
[2]
A more than two weeks interval between donations is required.
[3]
Administer the test material A.
[4]
A more than two weeks interval between donations is required.
[5]
Administer the test material C.
Interventions/Control_4
Duration:same as above
Test material:same as above
Administration:same as above
[1]
Administer the test material B.
[2]
A more than two weeks interval between donations is required.
[3]
Administer the test material C.
[4]
A more than two weeks interval between donations is required.
[5]
Administer the test material A.
Interventions/Control_5
Duration:same as above
Test material:same as above
Administration:same as above
[1]
Administer the test material C.
[2]
A more than two weeks interval between donations is required.
[3]
Administer the test material B.
[4]
A more than two weeks interval between donations is required.
[5]
Administer the test material A.
Interventions/Control_6
Duration:same as above
Test material:same as above
Administration:same as above
[1]
Administer the test material C.
[2]
A more than two weeks interval between donations is required.
[3]
Administer the test material A.
[4]
A more than two weeks interval between donations is required.
[5]
Administer the test material B.
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 69 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Volunteer staff who meet the criteria for Plateletpheresis donation
Key exclusion criteria
Volunteer staff who do not meet the criteria for Plateletpheresis donation
Target sample size
32
Research contact person
Name of lead principal investigator
| 1st name | Ayumi |
| Middle name | |
| Last name | Araki |
Organization
Japan Red Cross Society
Division name
Blood Service Headquarters
Zip code
1050011
Address
2-1 Shiba koen 1-Chome Minato-ku Tokyo
TEL
03-3437-7598
a-araki@jrc.or.jp
Public contact
Name of contact person
| 1st name | Ayumi |
| Middle name | |
| Last name | Araki |
Organization
Japan Red Cross Society
Division name
Blood Service Headquarters
Zip code
1050011
Address
2-1 Shiba koen 1-Chome Minato-ku Tokyo
TEL
03-3437-7598
Homepage URL
a-araki@jrc.or.jp
Sponsor or person
Institute
Japan Red Cross Society
Institute
Department
Personal name
Funding Source
Organization
Self-funding
Japan Red Cross Society
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
Japan Red Cross Society
Address
2-1 Shiba koen 1-Chome Minato-ku Tokyo
Tel
03-3437-7598
saiketsu@jrc.or.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
| 2019 | Year | 09 | Month | 02 | 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
36
Results
Results date posted
| 2021 | Year | 03 | Month | 09 | Day |
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
Main results already published
Date of protocol fixation
| 2019 | Year | 04 | Month | 02 | Day |
Date of IRB
| 2019 | Year | 04 | Month | 02 | Day |
Anticipated trial start date
| 2019 | Year | 07 | Month | 02 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 03 | Month | 23 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 08 | Month | 30 | Day |
Last modified on
| 2021 | Year | 03 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043155
