UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047532 |
|---|---|
| Receipt number | R000054209 |
| Scientific Title | Iron absorption kinetics immediately after endurance exercise in long distance runners. |
| Date of disclosure of the study information | 2022/04/29 |
| Last modified on | 2022/10/26 13:29:32 |
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Basic information
Public title
Iron absorption kinetics immediately after endurance exercise in long distance runners.
Acronym
Iron absorption kinetics immediately after endurance exercise in long distance runners.
Scientific Title
Iron absorption kinetics immediately after endurance exercise in long distance runners.
Scientific Title:Acronym
Iron absorption kinetics immediately after endurance exercise in long distance runners.
Region
| Japan |
Condition
Condition
Healthy athletes at risk for anemia.
Classification by specialty
| Medicine in general | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study examines the effect of endurance exercise on iron absorption.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Serum iron 3 hours after taking iron tablets
Key secondary outcomes
Serum hepcidin
Serum IL-6 concentration
Hemoglobin
Hematocrit
Serum ferritin
TIBC
RBC
MCV, MCH, MCHC
Reticulocyte counts
WBC
PLT
Hemogram
UIBC
Serum zinc
Serum Total Protein
Serum albumin
ALT, AST
LD
CK
CRE
Oxygen uptake
Minute ventilation
Heart rate
Core temperature
Salivary IgA concentration
Helicobacter pylori antigen in stool
Subjective index (fatigue level)
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food | Behavior,custom |
Interventions/Control_1
1.Take 35 mg of iron supplements after high-intensity exercise.
2.washout period: 1 week
3.Take 35 mg of iron supplements at rest.
Interventions/Control_2
1.Take 35 mg of iron supplements at rest.
2.washout period: 1 week
3.Take 35 mg of iron supplements after high-intensity exercise.
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
Male
Key inclusion criteria
1.Healthy college track and field long distance runners.
2.Participants who fully understood study purpose and contents and gave written informed consent.
Key exclusion criteria
1.Participants who have a history of cardiovascular, respiratory, or brain disease.
2.Participants with a history of cigarette smoking.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Fujii |
| Middle name | |
| Last name | Naoto |
Organization
University of Tsukuba
Division name
Faculty of Health and Sport Sciences
Zip code
305-8574
Address
1-1-1, Tennodai, Tsukuba-shi, Ibaragi
TEL
029-853-8675
fujii.naoto.gb@u.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Fujii |
| Middle name | |
| Last name | Naoto |
Organization
University of Tsukuba
Division name
Faculty of Health and Sport Sciences
Zip code
305-8574
Address
1-1-1, Tennodai, Tsukuba-shi, Ibaragi
TEL
029-853-8675
Homepage URL
fujii.naoto.gb@u.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
Subsidy from the University of Tsukuba
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Human ethical committee of University of Tsukuba.
Address
1-1-1, Tennodai, Tsukuba-shi, Ibaragi
Tel
029-853-2571
tg-kenkyurinri@un.tsukuba.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
筑波大学（茨城県）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 04 | Month | 29 | 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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 04 | Month | 19 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 19 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 20 | Day |
Last follow-up date
| 2023 | 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 | 04 | Month | 20 | Day |
Last modified on
| 2022 | Year | 10 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054209
