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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000003834
Receipt No. 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

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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
Email 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
Email nakaik@med.tohoku.ac.jp

Sponsor
Institute Tohoku University Graduate School of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.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


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