UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003834 |
|---|---|
| Receipt number | R000004616 |
| Scientific Title | An Interventional Study to Reduce the Body Burden of POPs in Young Females |
| Date of disclosure of the study information | 2010/06/28 |
| Last modified on | 2016/06/28 09:29:30 |
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Basic information
Public title
An Interventional Study to Reduce the Body Burden of POPs in Young Females
Acronym
POPs reduction interventional study
Scientific Title
An Interventional Study to Reduce the Body Burden of POPs in Young Females
Scientific Title:Acronym
POPs reduction interventional study
Region
| Japan |
Condition
Condition
Japanese healthy subjects
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Reduction of persistent organic pollutants in young females will be examined by providing the information on POPs contamination in food.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Plasma PCB and DDE concentrations
Key secondary outcomes
Omega-3 and Omega-6 polyunsaturated fatty acids in red cell membrane
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Providing the information on the contamination with POPs in fish and shellfish and the effective cooking methods to avoid the exposure.
Interventions/Control_2
Control group wothout providing the information
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
| 18 | years-old | <= |
Age-upper limit
| 30 | years-old | >= |
Gender
Female
Key inclusion criteria
Healthy subjects.
BMI between 18.5 and 25 kg/m2.
Key exclusion criteria
No birth history.
Pregnancy or lactation.
Target sample size
135
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kunihiko NAKAI |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Development and Environmental Medicine
Zip code
Address
2-1 seiryo-machi, Aoba-ku, Sendai, Miyagi, JAPAN
TEL
+81-22-717-8949
nakaik@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kunihiko NAKAI |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Development and Environmental Medicine
Zip code
Address
2-1 seiryo-machi, Aoba-ku, Sendai, Miyagi, JAPAN
TEL
+81-22-717-8949
Homepage URL
nakaik@med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of the Environment
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
東北大学大学院医学系研究科
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 06 | Month | 28 | 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
133 of 135 registered females completed the baseline examination including food frequency questionnaire and blood collection.
Information on POPs contaminats in food were provided for the intervention (66 subjects for the interventional group and 67 subjects for the control group).
After the intervention of 20 months, the number of subjects were 130 (65 for the both groups). The intervation was already finished and the results would be publisfed soon.
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
No longer recruiting
Date of protocol fixation
| 2009 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2013 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2013 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 06 | Month | 28 | Day |
Last modified on
| 2016 | Year | 06 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004616
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
