UMIN-CTR Clinical Trial

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
Email	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
Email	a-araki@jrc.or.jp

Sponsor
Institute	Japan Red Cross Society
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043155