UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	An Interventional Study to Reduce the Body Burden of POPs in Young Females
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Kunihiko NAKAI
Organization	Tohoku University Graduate School of Medicine
Division name	Department of Development and Environmental Medicine
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	Kunihiko NAKAI
Organization	Tohoku University Graduate School of Medicine
Division name	Department of Development and Environmental Medicine
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

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2009 Year 11 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
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.
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/icdr_e/ctr_view.cgi?recptno=R000004616