UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060520 |
|---|---|
| Receipt number | R000069126 |
| Scientific Title | preliminary study aims to evaluate the absorption of calcium formulations |
| Date of disclosure of the study information | 2026/01/30 |
| Last modified on | 2026/01/30 14:36:10 |
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Basic information
Public title
preliminary study aims to evaluate the absorption of calcium formulations
Acronym
preliminary study aims to evaluate the absorption of calcium formulations
Scientific Title
preliminary study aims to evaluate the absorption of calcium formulations
Scientific Title:Acronym
preliminary study aims to evaluate the absorption of calcium formulations
Region
| Japan |
Condition
Condition
Healthy volunteers
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate of the absorption of calcium formulations and examine protocol optimization of this study protocol
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Calcium Absorption Assessed by Urinary Excretion
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Washout>Test Food 1>Test Food 2>Test Food 3
Washout& Test Food 1> Washout& Test Food 2> Washout& Test Food 3
Interventions/Control_2
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
| 69 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Healthy Japanese males and females aged 20 years old or older but under 70 at the time of consent.
2)Employees of Universal Calcium Food Co., Ltd. and students of the Faculty of Biology-Oriented Science and Technology, KINDAI UNIVERSITY.
3)Individuals who have received sufficient explanation about the study and have signed the informed consent form prior to the study initiation.
Key exclusion criteria
1)Individuals who have been advised by a physicians or other healthcare professionals to restrict the intake of calcium-containing foods or supplements.
2)Individuals with food allergies or those who may be allergic to the test food.
3)Individuals who are pregnant or breastfeeding
4)Individuals who participated in another clinical trial within one month prior to the date of consent, or plan to participate in another clinical trial during the study period.
5)Individuals deemed inappropriate for participation by the principal investigator.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Nobuyuki |
| Middle name | |
| Last name | Okubo |
Organization
Universal Calcium Food Co., Ltd.
Division name
Production Control Department
Zip code
150-0002
Address
8F & 9F, Shibuya 3-chome TR Bldg., 3-8-11 Shibuya, Shibuya-ku, Tokyo 150-0002, Japan
TEL
03-5469-0923
okubo@unical.co.jp
Public contact
Name of contact person
| 1st name | Nobuyuki |
| Middle name | |
| Last name | Okubo |
Organization
Universal Calcium Food Co., Ltd.
Division name
Production Control Department
Zip code
150-0002
Address
8F & 9F, Shibuya 3-chome TR Bldg., 3-8-11 Shibuya, Shibuya-ku, Tokyo 150-0002, Japan
TEL
03-5469-0923
Homepage URL
okubo@unical.co.jp
Sponsor or person
Institute
Universal Calcium Food Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Universal Calcium Food 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
Ethics Review Committee of Watanabe Hospital
Address
1-5-16, Haneda, Otaku, Tokyo, 144-0043, Japan
Tel
03-3741-0223
food-contact@apoplus.co.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
| 2026 | Year | 01 | Month | 30 | 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
| 2026 | Year | 01 | Month | 07 | Day |
Date of IRB
| 2026 | Year | 01 | Month | 14 | Day |
Anticipated trial start date
| 2026 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 05 | 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
| 2026 | Year | 01 | Month | 30 | Day |
Last modified on
| 2026 | Year | 01 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069126
