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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000014755
Receipt No. R000017153
Scientific Title Omega-3 polyunsaturated fatty acids and psychological interventions for workers with mild to moderate depression: a randomized controlled trial
Date of disclosure of the study information 2014/09/01
Last modified on 2017/02/07

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Basic information
Public title Omega-3 polyunsaturated fatty acids and psychological interventions for workers with mild to moderate depression: a randomized controlled trial
Acronym Healing worker's depression by omega-3 polyunsaturated fatty acids and psychological interventions: a randomized controlled trial
Scientific Title Omega-3 polyunsaturated fatty acids and psychological interventions for workers with mild to moderate depression: a randomized controlled trial
Scientific Title:Acronym Healing worker's depression by omega-3 polyunsaturated fatty acids and psychological interventions: a randomized controlled trial
Region
Japan

Condition
Condition Job stress
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the efficacy of omega-3 fatty acids supplementation for psychological distress and depressive symptoms by comparing the outcome of the groups of omega-3 fatty acids supplementation added to psychological interventions and psychological interventions alone in workers
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase III

Assessment
Primary outcomes Beck depression Inventory-II
Key secondary outcomes -Kessler K6
-The Center for Epidemiologic Studies
-Depression Scale (CES-D)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification YES
Dynamic allocation
Institution consideration
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Psychological interventions + Omega-3 Polyunsaturated Fatty Acids
Interventions/Control_2 Psychological interventions
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
20 years-old <=
Age-upper limit
65 years-old >
Gender Male and Female
Key inclusion criteria Japanese workers
-A native Japanese speaking ability
-Those who can understand scope and contents in the trial
Key exclusion criteria Us of warfarin within 3 month at regular intervals
Target sample size 78

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Susumu Shirabe
Organization Nagasaki University
Division name Center for Health and Community Medicine
Zip code
Address 1-14 Bunkyo, Nagasaki 852-8521
TEL 095-819-2214
Email shirabe@nagasaki-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Jun Tayama
Organization Nagasaki University
Division name Graduate School of Education
Zip code
Address 1-14 Bunkyo, Nagasaki 852-8521
TEL 095-819-2214
Homepage URL
Email jtayama@nagasaki-u.ac.jp

Sponsor
Institute Nagasaki University
Institute
Department

Funding Source
Organization Japan society for the promotion of science
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Health Sciences University of Hokkaido
University of Toyama
Saitama Prefectural University
Tohoku University
Tohoku Fukushi University
Kurume University
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 長崎大学保健・医療推進センター(長崎県)、埼玉県立大学保健医療福祉学部(埼玉県)、別府大学文学部(大分県)

Other administrative information
Date of disclosure of the study information
2014 Year 09 Month 01 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
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 Enrolling by invitation
Date of protocol fixation
2014 Year 07 Month 25 Day
Date of IRB
Anticipated trial start date
2014 Year 10 Month 06 Day
Last follow-up date
2015 Year 12 Month 31 Day
Date of closure to data entry
2016 Year 01 Month 31 Day
Date trial data considered complete
2016 Year 02 Month 29 Day
Date analysis concluded
2016 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2014 Year 08 Month 04 Day
Last modified on
2017 Year 02 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017153

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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