UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048585 |
|---|---|
| Receipt number | R000055348 |
| Scientific Title | Effect of combined intake of iron supplement and protein on anemia-related indices |
| Date of disclosure of the study information | 2022/08/04 |
| Last modified on | 2024/03/18 10:18:41 |
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Basic information
Public title
Effect of combined intake of iron supplement and protein on anemia-related indices
Acronym
Effect of combined intake of iron supplement and protein on anemia-related indices
Scientific Title
Effect of combined intake of iron supplement and protein on anemia-related indices
Scientific Title:Acronym
Effect of combined intake of iron supplement and protein on anemia-related indices
Region
| Japan |
Condition
Condition
Anemia
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the effect of 4-weeks combined intake of iron supplemantat and protein on anemia-related indices
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Hemoglobin concentration
Key secondary outcomes
Hematocrit
Blood cell count
Reticulocyte count
Ferritin concentration
Serum iron concentration
Total iron binding capacity
Unsaturated iron binding capacity
Hepcidin concentration
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Ingesting heme iron supplement (containing 12mg of iron) and protein powder (containing 25g of protein) everyday for 4 weeks.
Interventions/Control_2
Ingesting heme iron supplement (containing 12mg of iron) everyday for 4 weeks.
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
| 25 | years-old | >= |
Gender
Female
Key inclusion criteria
Female athletes who regularly train.
Key exclusion criteria
Those who currently take high amount of protein (more than 2g /kg(body weight)).
Those who currently take iron or protein supplement.
Those who have hemoglobin concentration less than 10 g/dL during the pre-screening and intervention phases.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Kumpei |
| Middle name | |
| Last name | Tanisawa |
Organization
Waseda University
Division name
Faculty of Sport Sciences
Zip code
359-1192
Address
2-579-15 Mikajima, Tokorozawa, Saitama, 359-1192, Japan
TEL
04-2947-6745
tanisawa@waseda.jp
Public contact
Name of contact person
| 1st name | Kumpei |
| Middle name | |
| Last name | Tanisawa |
Organization
Waseda University
Division name
Faculty of Sport Sciences
Zip code
359-1192
Address
2-579-15 Mikajima, Tokorozawa, Saitama, 359-1192, Japan
TEL
04-2947-6745
Homepage URL
tanisawa@waseda.jp
Sponsor or person
Institute
Waseda University
Institute
Department
Personal name
Funding Source
Organization
Waseda University
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
Waseda University
Address
Totsuka-cho 1-104, Shinjuku-ku, Tokyo, 169-8050, Japan
Tel
03-5272-4652
rinri@list.waseda.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 | 08 | Month | 04 | 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
Completed
Date of protocol fixation
| 2022 | Year | 08 | Month | 04 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 05 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 22 | 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 | 08 | Month | 04 | Day |
Last modified on
| 2024 | Year | 03 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055348
