UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045253 |
|---|---|
| Receipt number | R000051693 |
| Scientific Title | Effect of iron-containing food intake on metabolism for iron |
| Date of disclosure of the study information | 2021/08/24 |
| Last modified on | 2022/02/22 09:07:17 |
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Basic information
Public title
Effect of iron-containing food intake on metabolism for iron
Acronym
Effect of iron-containing food intake on metabolism for iron
Scientific Title
Effect of iron-containing food intake on metabolism for iron
Scientific Title:Acronym
Effect of iron-containing food intake on metabolism for iron
Region
| Japan |
Condition
Condition
Healthy women
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Purpose of this clinical test are the effect of the test food, iron derived from beans, on the recovery of iron levels after menstruation, and to assess the usefulness and safety of iron derived from beans.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in hemoglobin before and after intervention
Key secondary outcomes
Ferritin, red blood cells, serum iron, serum zinc, serum copper, hematocrit, TIBC, MCH, MCHC, anemia symptoms questionnaire, OSA sleep questionnaire, anti-fatigue questionnaire
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Intake of foods containing pea-derived ferritin iron
Interventions/Control_2
Intake of Placebo
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
| 20 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Female
Key inclusion criteria
(1) Women who experience iron deficiency on a daily basis (anemia symptoms)
(2) Premenopausal women
(3) Women with a BMI of less than 30 kg/m2
(4)Those whose menstruation is in a designated cycle (within 1 week of the end of menstruation on July 28 and 29: follicular phase, end of menstruation on August 3 and 4 or within 3 days of the end of menstruation)
(5)Those whose menstrual cycle is relatively stable
(6)Those who can voluntarily consent to participate in the study in writing
(7) Patients who have had a hemoglobin level of less than 13 g/dL (preferably less than 12 g/dL) in a previous blood test
Key exclusion criteria
(1) Those who are allergic to beans (soybeans, peas, and other legumes in general)
(2) Those who are currently on medication for iron deficiency anemia.
(3) Those who are currently receiving medication for any disease.
(4) Those who are taking the food (soy milk) or health food containing the ingredients of this test food
(5) Those with irregular menstrual cycles
(6) Persons with serious diseases of glucose metabolism, lipid metabolism, liver function, kidney function, heart, circulatory system, respiratory system, endocrine system, immune system, nervous system, or mental disorders. (6) Those who have a history of serious diseases or mental disorders, and those who have a history of such diseases.
(7) Those who have abnormal clinical laboratory values and are judged to have a problem with participation in the study.
(8) Those who have a disease under treatment or a history of serious disease requiring medication.
(9) Those who may develop allergies related to the study.
(10)Those who are judged to be unsuitable as subjects based on the results of the answers to the lifestyle questionnaire.
(11)Those who are participating in other clinical research at the time of the start of this study.
(12) Those who are pregnant or plan to become pregnant or breastfeed during the study period
(13) Patients with uterine fibroids or endometriosis
(14)Those who are judged by the principal investigator to be unsuitable for participation in the study.
Target sample size
42
Research contact person
Name of lead principal investigator
| 1st name | Yujji |
| Middle name | |
| Last name | Kuriyama |
Organization
Juntendo University School of Medicine
Division name
Department of General Medicine
Zip code
113-8421
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo 113-8421 Japan
TEL
03-3813-311
kuri@a2-pro.com
Public contact
Name of contact person
| 1st name | Yoshihiro |
| Middle name | |
| Last name | Otake |
Organization
feileB Co.Ltd
Division name
Clinical Trial Session
Zip code
160-0015
Address
7th Floor Gran-First Shinjyuku-Gyoen Bldg, 22-1 Daikyo-cho, Shinjyuku-ku, Tokyo 160-0015, Japan
TEL
03-6416-4228
Homepage URL
otake@feileb.jp
Sponsor or person
Institute
Anti-Aging Pro Corporation
Institute
Department
Personal name
Funding Source
Organization
Anti-Aging Pro Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tsukiji Futaba Clinic institutional review board
Address
Hosokawa-Tsukiji Build. 6F, Tsukiji 1-9-9, Cyuou-ku, Tokyo
Tel
03-6226-5812
tohru@hikobae.net
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
| 2021 | Year | 08 | Month | 24 | 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
| 2021 | Year | 07 | Month | 19 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 20 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 25 | Day |
Last follow-up date
| 2021 | Year | 12 | 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
| 2021 | Year | 08 | Month | 24 | Day |
Last modified on
| 2022 | Year | 02 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051693
