UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050570 |
|---|---|
| Receipt number | R000057581 |
| Scientific Title | The effect of omega-3 fatty acids intake on hepcidin and anemia |
| Date of disclosure of the study information | 2023/03/14 |
| Last modified on | 2024/03/14 16:11:20 |
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Basic information
Public title
The effect of omega-3 fatty acids intake on hepcidin and anemia
Acronym
Omega-3 HA study
Scientific Title
The effect of omega-3 fatty acids intake on hepcidin and anemia
Scientific Title:Acronym
Omega-3 HA study
Region
| Japan |
Condition
Condition
Anemia
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the effect of omega-3 fatty acids intake on hepcidin and anemia in female atheletes
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Hepcidin
ferritin
Key secondary outcomes
Body composition
Dietary assessment
Hematological parameters
Menstruation and menstruation-related problems
Gut microbiome
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment | Behavior,custom |
Interventions/Control_1
Omega-3 fatty acids supplementation
Interventions/Control_2
Usual diet
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
| 18 | years-old | <= |
Age-upper limit
| 30 | years-old | > |
Gender
Female
Key inclusion criteria
1) Aged 18-29.
2) Female
3) College student
4) Athlete or non-athlete population (control)
Key exclusion criteria
1) Anti-coagulant therapy
2) Easy bruising and bleeding
3) Omega-3 polyunsaturated fatty acid supplementatio
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Mami |
| Middle name | |
| Last name | Fujibayashi |
Organization
Setsunan University
Division name
Faculty of Agriculture
Zip code
573-0101
Address
Nagaotoge-cho 45-1, Hirakata-City, Osaka
TEL
072-896-6349
mami.fujibayashi@setsunan.ac.jp
Public contact
Name of contact person
| 1st name | Mami |
| Middle name | |
| Last name | Fujibayashi |
Organization
Setsunan University
Division name
Faculty of Agriculture
Zip code
573-0101
Address
Nagaotoge-cho 45-1, Hirakata-City, Osaka
TEL
072-896-6349
Homepage URL
Mami.fujibayashi@setsunan.ac.jp
Sponsor or person
Institute
Setsunan University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
National Hospital Organization Kyoto Medical Center
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Setsunan University Ethical Review Committee for Medical and Health Research Involving Human Subjects
Address
Nagaotoge-cho 45-1, Hirakata-City, Osaka
Tel
072-896-6349
mami.fujibayashi@setsunan.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
| 2023 | Year | 03 | Month | 14 | 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
112
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
Main results already published
Date of protocol fixation
| 2023 | Year | 02 | Month | 24 | Day |
Date of IRB
| 2023 | Year | 02 | Month | 24 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 20 | 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
| 2023 | Year | 03 | Month | 13 | Day |
Last modified on
| 2024 | Year | 03 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057581
