UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047925 |
|---|---|
| Receipt number | R000054532 |
| Scientific Title | Investigation for the recovery of iron store in the body and the efficacy of iron supplementation ater blood donation |
| Date of disclosure of the study information | 2022/06/03 |
| Last modified on | 2022/06/02 11:34:37 |
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Basic information
Public title
Investigation for the recovery of iron store in the body and the efficacy of iron supplementation ater blood donation
Acronym
Investigation for the recovery of iron store in the body and the efficacy of iron supplementation ater blood donation
Scientific Title
Investigation for the recovery of iron store in the body and the efficacy of iron supplementation ater blood donation
Scientific Title:Acronym
Investigation for the recovery of iron store in the body and the efficacy of iron supplementation ater blood donation
Region
| Japan |
Condition
Condition
No
Classification by specialty
| Blood transfusion |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the recovery of iron store in the body and the efficacy of iron supplementation
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The changes of serum ferritin until 48 weeks after blood donation, and that with administration of iron supplementation
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
Treatment
Type of intervention
| Other |
Interventions/Control_1
iron supplementation (ferric citrate hydrate, 12 mg/day, 12 weeks)
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
| 69 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
healthy volunteer
Key exclusion criteria
serum ferritin level exceed 300 ng/mL, gastrointestinal diseases (ulcer, enterocolitis), paroxysmal nocturnal hematuria
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Katsuya |
| Middle name | |
| Last name | Ikuta |
Organization
Japan Red Cross Society
Division name
Blood Service Headquaters
Zip code
1050011
Address
2-1 Shiba koen 1-Chome Minato-ku, Tokyo
TEL
03-3437-7598
k-ikuta@hokkaido.bc.jrc.or.jp
Public contact
Name of contact person
| 1st name | Katsuya |
| Middle name | |
| Last name | Ikuta |
Organization
Japan Red Cross Society
Division name
Blood Service Headquaters
Zip code
1050011
Address
2-1 Shiba koen 1-Chome Minato-ku, Tokyo
TEL
03-3437-7598
Homepage URL
k-ikuta@hokkaido.bc.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
| 2022 | Year | 06 | Month | 03 | 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
Preinitiation
Date of protocol fixation
| 2022 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 12 | Month | 17 | Day |
Anticipated trial start date
| 2022 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2025 | 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 | 06 | Month | 02 | Day |
Last modified on
| 2022 | Year | 06 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054532
