UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058815 |
|---|---|
| Receipt number | R000067259 |
| Scientific Title | An intervention study to evaluate the efficacy of combined DHA and vitamin D supplementation on bone metabolism in healthy participants |
| Date of disclosure of the study information | 2026/03/31 |
| Last modified on | 2025/08/16 18:57:37 |
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Basic information
Public title
The effects of test foods containing DHA and vitamin D on bone in healthy participants
Acronym
The effects of DHA and vitamin D intake on bone in healthy participants
Scientific Title
An intervention study to evaluate the efficacy of combined DHA and vitamin D supplementation on bone metabolism in healthy participants
Scientific Title:Acronym
An intervention study on the efficacy of combined supplementation with DHA and vitamin D on bone metabolism in healthy participants
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effects of consuming test foods containing DHA and vitamin D on bone metabolites in healthy women.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Vitamin D metabolites
Bone metabolic markers
Key secondary outcomes
Bone density
Blood characteristics
Subjective health perception
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
4
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Consumption of test foods
(4 weeks each in summer and winter)
Interventions/Control_2
Consumption of test foods
(4 weeks each in summer and winter)
Interventions/Control_3
Consumption of test foods
(4 weeks each in summer and winter)
Interventions/Control_4
Consumption of test foods
(4 weeks each in summer and winter)
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
| 65 | years-old | > |
Gender
Female
Key inclusion criteria
1) Directly employed by Fuji Oil Co., Ltd. and able to visit the health management office on the day of blood sampling
2) Written consent for participation in the study has been obtained from the participant
3) Able to communicate in Japanese
Key exclusion criteria
1)Individuals currently taking DHA or EPA
2)Individuals currently taking vitamin D
3)Individuals who regularly consume vitamin D-fortified foods (e.g., egg yolks)
4)Individuals using medications containing vitamin D due to skin conditions
5)Individuals currently receiving medication for osteoporosis prescribed by a physician
6)Individuals who have experienced abnormal symptoms such as feeling unwell or a drop in blood pressure during or after blood collection.
7)Other individuals deemed ineligible for this study by an occupational physician.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Ichinose |
Organization
Fuji Oil Co., Ltd.
Division name
Research Institute for Creating the Future
Zip code
300-2497
Address
4-3 Kinunodai, Tsukubamirai, Ibaraki, Japan.
TEL
0297-52-6325
ichinose.takashi@so.fujioil.co.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Ichinose |
Organization
Fuji Oil Co., Ltd.
Division name
Research Institute for Creating the Future
Zip code
300-2497
Address
4-3 Kinunodai, Tsukubamirai, Ibaraki, Japan.
TEL
0297-52-6325
Homepage URL
ichinose.takashi@so.fujioil.co.jp
Sponsor or person
Institute
Fuji Oil Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Osaka Metropolitan University
JEOL Ltd.
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
Fuji Oil IRB
Address
4-3 Kinunodai, Tsukubamirai, Ibaraki, Japan.
Tel
0297-52-6325
nakano.mikio@so.fujioil.co.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
2025-05
Org. issuing International ID_1
Research Ethics Committee, School of Human Life and Ecology, Osaka Metropolitan University
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
不二製油株式会社（大阪府）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 03 | Month | 31 | 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
| 2025 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 02 | Day |
Anticipated trial start date
| 2025 | Year | 08 | Month | 22 | Day |
Last follow-up date
| 2026 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 08 | Month | 16 | Day |
Last modified on
| 2025 | Year | 08 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067259
