UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047010 |
|---|---|
| Receipt number | R000051974 |
| Scientific Title | An investigation of factors associated with iron deficiency in high school long-distance runners |
| Date of disclosure of the study information | 2022/02/26 |
| Last modified on | 2025/09/03 11:45:56 |
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Basic information
Public title
An investigation of factors associated with iron deficiency in high school long-distance runners
Acronym
An investigation of factors associated with iron deficiency in high school long-distance runners
Scientific Title
An investigation of factors associated with iron deficiency in high school long-distance runners
Scientific Title:Acronym
An investigation of factors associated with iron deficiency in high school long-distance runners
Region
| Japan |
Condition
Condition
Normal
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate factors associated with iron deficiency in high school long-distance runners.
Basic objectives2
Others
Basic objectives -Others
Examination of new factors affecting the primary outcome
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Serum hepcidin
Key secondary outcomes
Energy balance
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 15 | years-old | <= |
Age-upper limit
| 18 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) high school long-distance runners.
(2) must be in good physical condition.
(3) those who voluntarily participate in this study with written informed consent.
Key exclusion criteria
(1) Subjects with heart disease and/or respiratory disease and/or injury and/or hematologic disease
(2) Subjects receiving treatment (medicine prescription by physician).
(3) Subjects who are judged as unsuitable for this study by physician.
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Michiyo |
| Middle name | |
| Last name | Kimura |
Organization
Takasaki University of Health and Welfare
Division name
Faculty of Health and Welfare
Zip code
370-0033
Address
37-1 Nakaorui,Takasaki city,Gunma
TEL
0273521290
kimura@takasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Michiyo |
| Middle name | |
| Last name | Kimura |
Organization
Takasaki University of Health and Welfare
Division name
Faculty of Health and Welfare
Zip code
370-0033
Address
37-1 Nakaorui,Takasaki city,Gunma
TEL
0273521290
Homepage URL
kimura@takasaki-u.ac.jp
Sponsor or person
Institute
Takasaki University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Takasaki University of Health and Welfare
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Takasaki University of Health and Welfare
Address
37-1 Nakaorui,Takasaki city,Gunma
Tel
0273521290
mune@takasaki-u.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 | 26 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
21
Results
Hb concentration significantly increased from autumn to spring and significantly decreased from spring to summer.
EA significantly decreased from winter to summer in males, and from spring to summer in females.
Hepcidin concentration showed no clear seasonal variation.
The summer decline in Hb concentration may be associated with reduced EA.
Results date posted
| 2025 | Year | 09 | Month | 03 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
Analysis was delayed due to the transfer of the researcher in charge.
Date of the first journal publication of results
Baseline Characteristics
High school long-distance runners
Both male and female participants engaged in daily endurance training
Age: equivalent to Japanese high school students (15-18 years)
No notable underlying diseases
Participant flow
21 participants enrolled, evaluated in autumn, winter, spring, and summer. No dropouts.
Adverse events
No adverse events were observed
Outcome measures
Primary endpoints
Seasonal variation of blood Hb concentration
Secondary endpoints
EA (calculated from TEI, EEE, and fat-free mass)
Blood hepcidin concentration
Body composition
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 07 | Month | 31 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 24 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Longitudinal study
Physical activity questionnaire
Energy intake
Energy expenditure
Body composition
Serum hepcidin
Management information
Registered date
| 2022 | Year | 02 | Month | 26 | Day |
Last modified on
| 2025 | Year | 09 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051974
