UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036609 |
|---|---|
| Receipt number | R000041706 |
| Scientific Title | Intervention study of recognition about dietary supplement among pharmaceutical students and pharmacists. |
| Date of disclosure of the study information | 2020/05/01 |
| Last modified on | 2024/04/03 10:30:14 |
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Basic information
Public title
Intervention study of recognition about dietary supplement among pharmaceutical students and pharmacists.
Acronym
Intervention study of recognition about dietary supplement.
Scientific Title
Intervention study of recognition about dietary supplement among pharmaceutical students and pharmacists.
Scientific Title:Acronym
Intervention study of recognition about dietary supplement.
Region
| Japan |
Condition
Condition
Non
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of lesson on attitude toward health foods/dietary supplements in university students and pharmacists.
Basic objectives2
Others
Basic objectives -Others
Attitude toward health foods/dietary supplements in university students and pharmacists.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Questionnaire about attitude toward health foods/dietary supplements
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
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
lesson (One hour)
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
| 22 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Pharmaceutical students
Pharmacists
Key exclusion criteria
Non
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Chiba |
Organization
National Institutes of Biomedical Innovation, Health and Nutrition
Division name
Department of Food Function and Labeling
Zip code
162-8636
Address
1-23-1 Toyama, Shinjuku-ku, Tokyo
TEL
03-3203-8063
tyschiba@nibiohn.go.jp
Public contact
Name of contact person
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Chiba |
Organization
National Institutes of Biomedical Innovation, Health and Nutrition
Division name
Department of Food Function and Labeling
Zip code
162-8636
Address
1-23-1 Toyama, Shinjuku-ku, Tokyo
TEL
03-3203-8063
Homepage URL
tyschiba@nibiohn.go.jp
Sponsor or person
Institute
National Institutes of Biomedical Innovation, Health and Nutrition
Institute
Department
Personal name
Funding Source
Organization
non
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Teikyo University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Institutes of Biomedical Innovation, Health and Nutrition
Address
7-6-8, Saito-Asagi, Ibaraki City, Osaka
Tel
072-641-9829
irb-office@nibiohn.go.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
帝京大学（東京都）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 05 | Month | 01 | Day |
Related information
URL releasing protocol
Unpublished
Publication of results
Unpublished
Result
URL related to results and publications
Unpublished
Number of participants that the trial has enrolled
500
Results
As a result of the 1-hour lecture intervention, an improvement was observed in the participants' awareness of healthy foods, especially regarding safety-related items.
Additionally, half of the students who use health foods said they would reconsider continuing to use them.
Due to the influence of the coronavirus pandemic, it was not possible to conduct a follow-up survey after graduation.
Results date posted
| 2023 | Year | 11 | Month | 01 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Pharmacy students
Participant flow
The outline of the survey will be explained to the lecture participants in advance, and only those students who have given their consent will respond to the survey.
Adverse events
None
Outcome measures
Changes in awareness regarding dietary supplements before and after the lecture.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 05 | Month | 17 | Day |
Date of IRB
| 2019 | Year | 07 | Month | 25 | Day |
Anticipated trial start date
| 2019 | Year | 07 | Month | 25 | Day |
Last follow-up date
| 2022 | Year | 03 | 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
| 2019 | Year | 04 | Month | 26 | Day |
Last modified on
| 2024 | Year | 04 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041706
| 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 |
