UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033287 |
|---|---|
| Receipt number | R000037951 |
| Scientific Title | Study on reducing the amount of neonicotinoid in urine by ingesting organic agricultural products |
| Date of disclosure of the study information | 2022/03/31 |
| Last modified on | 2024/07/09 13:50:41 |
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Basic information
Public title
Study on reducing the amount of neonicotinoid in urine by ingesting organic agricultural products
Acronym
Study on Neonicotinoids in urine
Scientific Title
Study on reducing the amount of neonicotinoid in urine by ingesting organic agricultural products
Scientific Title:Acronym
Study on Neonicotinoids in urine
Region
| Japan |
Condition
Condition
neonicotinoid poisoning
Classification by specialty
| Not applicable | Adult | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We clarify the exposure level of neonicotinoid insecticide in Japanese and clarify the reduction effect by ingesting organic crops.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
By analyzing the neonicotinoids in Japanese urine, we evaluate the exposure level. Also, clarify the reduction effect by eating organic vegetables that do not use insecticide.
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
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Ask a subject eating regular vegetables to eat organic vegetables and observe the change in the amount of neonicotinoid in the urine.
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
| 6 | years-old | <= |
Age-upper limit
| 40 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Parents of child-rearing generation and their children (ages 6 to 12) from 20 to 40 who can continuously eat organic vegetables,
Key exclusion criteria
Those who are older than 0 to 5 years old or 40 years old are excluded.
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | Yoshinori |
| Middle name | |
| Last name | Ikenaka |
Organization
Hokkaido University
Division name
Faculty of Veterinary Medicine
Zip code
060-0818
Address
Kita 18, Nishi 9, Kita-ku, Sapporo, Hokkaido
TEL
011-706-5102
y_ikenaka@vetmed.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Yoshinori |
| Middle name | |
| Last name | Ikenaka |
Organization
Hokkaido University
Division name
Faculty of Veterinary Medicine
Zip code
060-0818
Address
Kita 18, Nishi 9, Kita-ku, Sapporo, Hokkaido
TEL
011-706-5102
Homepage URL
y_ikenaka@vetmed.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University
Institute
Department
Personal name
Funding Source
Organization
Ministry of education
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hokkaido University
Address
Kita 18, Nishi 9, Kita-ku, Sapporo, Hokkaido
Tel
011-706-5102
y_ikenaka@vetmed.hokudai.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
| 2022 | Year | 03 | Month | 31 | Day |
Related information
URL releasing protocol
https://www.sciencedirect.com/science/article/pii/S0160412022000952
Publication of results
Unpublished
Result
URL related to results and publications
https://www.sciencedirect.com/science/article/pii/S0160412022000952
Number of participants that the trial has enrolled
103
Results
The mean and median cumulative levels of NNIs (median IMIeq) were significantly lower in the organic diet group than the conventional diet group (p < 0.0001). The estimated daily intakes (EDIs) of NNIs were higher in adults than children, but less than 1% of NNI cRfDs, except for clothianidin, which exhibited a %cRfD of 1.32 in children. Compared to the conventional diet group, the 5- and 30-day organic dietary intervention showed drastic reductions in NNI EDIs.
Results date posted
| 2024 | Year | 07 | Month | 09 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2022 | Year | 04 | Month | 01 | Day |
Baseline Characteristics
A total of 103 volunteers to help with the survey
Participant flow
A total of 103 volunteers to help with the survey
Adverse events
No
Outcome measures
Urinary neonicotinoid concentrations
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2018 | Year | 07 | Month | 31 | Day |
Date of IRB
| 2018 | Year | 07 | Month | 24 | Day |
Anticipated trial start date
| 2018 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 07 | Month | 05 | Day |
Last modified on
| 2024 | Year | 07 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037951
