UMIN-CTR Clinical Trial

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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