UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040090 |
|---|---|
| Receipt number | R000045708 |
| Scientific Title | Risk assessment in seeding operations by farmers handling pelleted seeds |
| Date of disclosure of the study information | 2020/04/16 |
| Last modified on | 2023/06/02 13:29:40 |
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Basic information
Public title
Risk assessment in seeding operations by farmers handling pelleted seeds
Acronym
Risk assessment in seeding operations by farmers handling pelleted seeds
Scientific Title
Risk assessment in seeding operations by farmers handling pelleted seeds
Scientific Title:Acronym
Risk assessment in seeding operations by farmers handling pelleted seeds
Region
| Japan |
Condition
Condition
Pneumoconiosis
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study was primarily to assess the risk of farmers seeding pelleted seeds (Assume independent onion farmers in Hokkaido). However, because it is difficult to collect data for health assessment by reading chest radiographs, it is necessary to assess the risks of farmers seeding pellets by estimating annual exposure levels of dust, silica, etc. in a simulated seeding environment and in processing workshops at pelleted seed production plants.
Basic objectives2
Others
Basic objectives -Others
Exposure evaluation
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Exposure level of dust
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
| Other |
Interventions/Control_1
Seeding of pseudo pelleted seeds in a simulated workroom mimicking a workhouse in an agricultural site (Injection of 330,000 pelleted seeds into high-speed seeding machine for 1 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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Healthy volunteers with normal respiratory function
Key exclusion criteria
Persons with impairment of physical function that makes it difficult to carry out pseudo seeding process
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | Narufumi |
| Middle name | |
| Last name | Suganuma |
Organization
Kochi University
Division name
Department of Environmental Medicine, Kochi Medical School
Zip code
783-8505
Address
Kohasu, Oko, Nankoku, Kochi
TEL
088-880-2407
nsuganuma@kochi-u.ac.jp
Public contact
Name of contact person
| 1st name | Masamitsu |
| Middle name | |
| Last name | Eitoku |
Organization
Kochi University
Division name
Department of Environmental Medicine, Kochi Medical School
Zip code
783-8505
Address
Kohasu, Oko, Nankoku, Kochi
TEL
088-880-2406
Homepage URL
meitoku@kochi-u.ac.jp
Sponsor or person
Institute
Kochi University
Institute
Department
Personal name
Funding Source
Organization
Japan Seed Trade Association
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Kochi Medical School
Address
Kohasu, Oko, Nankoku, Kochi
Tel
088-880-2180
is21@kochi-u.ac.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
| 2020 | Year | 04 | Month | 16 | Day |
Related information
URL releasing protocol
https://onlinelibrary.wiley.com/doi/epdf/10.1002/1348-9585.12304
Publication of results
Published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/epdf/10.1002/1348-9585.12304
Number of participants that the trial has enrolled
31
Results
The estimated annual occupational exposure level to total dust, respirable dust, and respirable crystalline silica in farmers was 10^3 to 10^4 times lower than established occupational exposure limits. Attapulgite was not detected by analysis of the pelleted seeds themselves or dust collected during the personal exposure measurements. No pulmonary parenchymal or pleural lesions were detected in the digital chest images of the factory workers.
Results date posted
| 2023 | Year | 06 | Month | 02 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Thirty-one male workers in the pellet seed production departments of four of the five Japanese pellet seed manufacturing companies, excluding one that had ceased production at the time this study was conducted, were included in the toxicity assessment.
Participant flow
Opted out of the use of existing materials held by a pellet seed manufacturing company, such as employee chest X-ray images and years of service, for research purposes.
Adverse events
No adverse events
Outcome measures
Pneumoconiosis and other pulmonary parenchymal and pleural lesions resulting from exposure to mineral dust
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 02 | Month | 28 | Day |
Date of IRB
| 2020 | Year | 02 | Month | 12 | Day |
Anticipated trial start date
| 2020 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 06 | Month | 01 | 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 | 04 | Month | 07 | Day |
Last modified on
| 2023 | Year | 06 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045708
| Research Plan | |
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| 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 |
