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Name
UMIN ID

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000048585
Receipt No. 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 2022/08/04

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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
Email 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
Email tanisawa@waseda.jp

Sponsor
Institute Waseda University
Institute
Department

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
Email 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 Preinitiation
Date of protocol fixation
2022 Year 08 Month 04 Day
Date of IRB
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
2022 Year 08 Month 04 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055348

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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