UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051959 |
|---|---|
| Receipt number | R000059303 |
| Scientific Title | Effects of a dairy ingredient on iron metabolism in healthy female subjects: a randomized, double-blind, placebo-controlled, parallel group, comparative superiority trial |
| Date of disclosure of the study information | 2023/08/21 |
| Last modified on | 2024/02/20 10:21:39 |
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Basic information
Public title
Effects of a dairy ingredient on iron metabolism in healthy female subjects: a randomized, double-blind, placebo-controlled, parallel group, comparative superiority trial
Acronym
Effects of a dairy ingredient on iron metabolism in healthy female subjects
Scientific Title
Effects of a dairy ingredient on iron metabolism in healthy female subjects: a randomized, double-blind, placebo-controlled, parallel group, comparative superiority trial
Scientific Title:Acronym
Effects of a dairy ingredient on iron metabolism in healthy female subjects
Region
| Japan |
Condition
Condition
None (Healthy subjects)
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of a dairy ingredient on iron metabolism.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
indices of iron metabolism
Key secondary outcomes
indices of iron metabolism
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Ingestion of dairy ingredient for 4 weeks.
Interventions/Control_2
Ingestion of placebo 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
| 50 | years-old | > |
Gender
Female
Key inclusion criteria
1)Female
2)Subjects between 18 to 50 years old.
3)Serum ferritin >= 12 ng/mL
Key exclusion criteria
1)Blood hemoglobin < 12 g/dL
2)Subjects who undergoes treatment for iron deficiency or anemia
3)Menopausal
4)Subjects who plans to donate blood during the test period
5)Subjects who regularly consume foods containing a dairy ingredient to be evaluated.
6)Subjects who take medicines or functional foods during the pre-test period, which might affect their iron metabolism.
7)Subjects who cannot stop taking medicines or functional foods during the test period, which might affect their iron metabolism.
8)Subjects who have serious disease in the liver, kidney, heart, lung, gastrointestinal tract, blood, endocrine system, or metabolic system etc. Or those who have serious medical history of these.
9)Subjects having a milk allergy.
10)Subjects who have medical history of drug allergy or severe food allergy
11)Subjects who are pregnant or under lactation, or who is expected to be pregnant during the study.
12)Subjects who donated 400 mL of their blood within 12 weeks before the beginning of test-food intakes, or not less than 200 mL of their blood during the pre-test period.
13)Others who have been determined as ineligible for the research subject of this study, judging from the principal researcher/doctor's opinions on the findings of their background, physical observations, medical checkup, physical/clinical examination, and so on.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Hiroki |
| Middle name | |
| Last name | Yoshida |
Organization
Kyushu University of Health and Welfare
Division name
Department of Pharmacy, Faculty of Pharmaceutical Sciences
Zip code
882-8508
Address
1714-1, Yoshino, Nobeoka, Miyazaki
TEL
0982-23-5574
h-yoshida@phoenix.ac.jp
Public contact
Name of contact person
| 1st name | Hiroki |
| Middle name | |
| Last name | Yoshida |
Organization
Kyushu University of Health and Welfare
Division name
Department of Pharmacy, Faculty of Pharmaceutical Sciences
Zip code
882-8508
Address
1714-1, Yoshino, Nobeoka, Miyazaki
TEL
0982-23-5574
Homepage URL
h-yoshida@phoenix.ac.jp
Sponsor or person
Institute
Kyushu University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Morinaga Milk Industry Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board at Kyushu University of Health and Welfare
Address
1714-1, Yoshino, Nobeoka, Miyazaki
Tel
0982-23-5574
h-yoshida@phoenix.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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 08 | Month | 21 | 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
| 2023 | Year | 08 | Month | 11 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 11 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 21 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 08 | Month | 21 | Day |
Last modified on
| 2024 | Year | 02 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059303
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
