UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040867 |
|---|---|
| Receipt number | R000046644 |
| Scientific Title | Clinical trial on changes in 25OHD3 level and vitamin D metabolites level in urine under the condition of increasing serum 25OHD level |
| Date of disclosure of the study information | 2020/06/23 |
| Last modified on | 2020/10/05 10:33:07 |
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Basic information
Public title
Clinical trial on changes in 25OHD3 level and vitamin D metabolites level in urine under the condition of increasing serum 25OHD level
Acronym
Clinical trial on changes in 25OHD3 level and vitamin D metabolites level in urine under the condition of increasing serum 25OHD level
Scientific Title
Clinical trial on changes in 25OHD3 level and vitamin D metabolites level in urine under the condition of increasing serum 25OHD level
Scientific Title:Acronym
Clinical trial on changes in 25OHD3 level and vitamin D metabolites level in urine under the condition of increasing serum 25OHD level
Region
| Japan |
Condition
Condition
Healthy Adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm changes in serum 25OHD level, urinary 25OHD3 level, and urinary vitamin D metabolite level under the condition of increasing serum 25OHD
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes in 25OHD3 and vitamin D metabolite levels in urine
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
Vitamin D supplementation for 7 days
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
| 65 | years-old | > |
Gender
Male
Key inclusion criteria
Healthy men over 20 and under 65
Key exclusion criteria
1) Subjects who have digestive system disease, renal disease, liver functional disease, metabolic disease
2) Subjects who take medication during study period (excluding anti-allergic agents)
3) Subjects who have taken vitamin D supplements since June this year
4) Subjects who have gelatin allergy
5) Subjects with difficulty in maintaining direct sunlight exposure for less than 30 minutes a day for 1 week
6) Subjects who smoke habitually
7) Others who are judged to be inappropriate for participation in this test by the test director
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Sayuri |
| Middle name | |
| Last name | Matsuoka |
Organization
FANCL Corporation
Division name
Research Institute, Health Science Research Center
Zip code
244-0806
Address
12-13, Kamishinano, Totsuka-ku, Yokohama, Kanagawa
TEL
045-820-3449
matsuoka@fancl.co.jp
Public contact
Name of contact person
| 1st name | Hiroto |
| Middle name | |
| Last name | Shinmura |
Organization
FANCL Corporation
Division name
Research Institute, Health Science Research Center
Zip code
244-0806
Address
12-13, Kamishinano, Totsuka-ku, Yokohama, Kanagawa
TEL
045-820-3420
Homepage URL
hishinmura@fancl.co.jp
Sponsor or person
Institute
FANCL Corporation
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
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Research Ethics Committee of FANCL Corporation
Address
12-13, Kamishinano, Totsuka-ku, Yokohama, Kanagawa
Tel
045-820-3657
akihide_nisihara@fancl.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
株式会社ファンケル 総合研究所 / FANCL Corporation Research Institute
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 06 | Month | 23 | 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
9
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
| 2020 | Year | 06 | Month | 17 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 19 | Day |
Anticipated trial start date
| 2020 | Year | 06 | Month | 26 | Day |
Last follow-up date
| 2020 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 06 | Month | 23 | Day |
Last modified on
| 2020 | Year | 10 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046644
