UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053585 |
|---|---|
| Receipt number | R000061149 |
| Scientific Title | Investigation of absorption of slow-release vitamin C raw materials in the body |
| Date of disclosure of the study information | 2024/03/01 |
| Last modified on | 2024/02/13 16:59:26 |
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Basic information
Public title
Investigation of absorption of slow-release vitamin C raw materials in the body
Acronym
Investigation of absorption of slow-release vitamin C raw materials in the body
Scientific Title
Investigation of absorption of slow-release vitamin C raw materials in the body
Scientific Title:Acronym
Investigation of absorption of slow-release vitamin C raw materials in the body
Region
| Japan |
Condition
Condition
Healthy population
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Check the absorption of vitamin C into the body when slow-release vitamin C raw materials are ingested.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
AUC for vitamin C concentration in blood
Key secondary outcomes
Blood vitamin C concentration at time point, Cmax, Tmax.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Sustained-release vitamin C preparations
Interventions/Control_2
Normal vitamin C preparations
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
| 50 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Healthy men and women between 20 and 50 years old
2)18.5 kg/m2 or more and less than 30.0 kg/m2
Key exclusion criteria
1)Participants with a history of serious illness or gastrointestinal surgery
2)Participants with diseases affecting gastric excretion and digestion/absorption, or with daily symptoms of indigestion, constipation, diarrhea, etc.
3)Participants with abnormal renal function, liver function, sugar or lipid metabolism
4)Participants who have concerns about their physical condition, such as headache, abdominal pain, or mental disorder.
5)Participants whose hemoglobin value is less than 11g/dl or who tend to be anemic at the most recent physical examination.
6)Participants whose total cholesterol is less than 120 mg/dl or who have a tendency to have a low appetite at the most recent physical examination.
7)Participants who regularly use medicines or supplements containing vitamin C group
8)Participants who are unable to discontinue taking medicines or supplements containing vitamin C group after obtaining consent
9)Heavy drinker or smoker of alcohol
10)Currently pregnant or lactating, or may become pregnant or lactating during the study period
11)Participants who have difficulty in having blood samples taken over time
12)Participants deemed unsuitable by the principal investigator
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | masaya |
| Middle name | |
| Last name | tsubokawa |
Organization
FANCL Research Institute
Division name
clinical trial group
Zip code
2440806
Address
12-13 Shinano, Totsuka-ku, Yokohama, Kanagawa Prefecture
TEL
045-820-3659
tsubokawa_masaya@fancl.co.jp
Public contact
Name of contact person
| 1st name | masaya |
| Middle name | |
| Last name | tsubokawa |
Organization
FANCL Research Institute
Division name
clinical trial group
Zip code
2440806
Address
12-13 Shinano, Totsuka-ku, Yokohama, Kanagawa Prefecture
TEL
045-820-3659
Homepage URL
tsubokawa_masaya@fancl.co.jp
Sponsor or person
Institute
other
Institute
Department
Personal name
Funding Source
Organization
other
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
FANCL Ethics Review Committee
Address
12-13 Shinano, Totsuka-ku, Yokohama, Kanagawa Prefecture
Tel
045-820-3659
tsubokawa_masaya@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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 03 | Month | 01 | 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
| 2024 | Year | 01 | Month | 16 | Day |
Date of IRB
| 2024 | Year | 01 | Month | 16 | Day |
Anticipated trial start date
| 2024 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 04 | Month | 29 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 02 | Month | 09 | Day |
Last modified on
| 2024 | Year | 02 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061149
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
