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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000027170
Receipt No. R000031038
Scientific Title The study for the correlation postpartum depression with omega-3 fatty acids: Observational and double blind study
Date of disclosure of the study information 2017/07/06
Last modified on 2017/04/27

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Basic information
Public title The study for the correlation postpartum depression with omega-3 fatty acids: Observational and double blind study
Acronym The postpartum depression and omega-3 fatty acids
Scientific Title The study for the correlation postpartum depression with omega-3 fatty acids: Observational and double blind study
Scientific Title:Acronym The postpartum depression and omega-3 fatty acids
Region
Japan

Condition
Condition Pregnant
Classification by specialty
Obsterics and gynecology Emergency medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aims of this study are to observe the effects of two kinds of omega-3 fatty acid source for the mood disorders during perinatal period, and to examine the correlation between supplemental omega-3 fatty acids and basal parameters on delivery.
Basic objectives2 Others
Basic objectives -Others Comparison with Historical Control
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Total score of Edinburgh Postnatal Depression Scale (EPDS) [time frame: one month after delivery].
Key secondary outcomes Kessler Screening Scale for Psychological Distress (K6) [time frame: second trimesters, after childbirth and one month after childbirth]
Fatty acid composition of serum and erythrocyte [time frame: first, second and third trimesters, after childbirth]
Fatty acid composition of umbilical cord blood and breast milk [time frame: after childbirth]
Serum (Corticosterone, Oxytocin)
Breast milk (IgA level, Peroxidase activity,
Protease activity, beta-casein)
Sex and body weight of newborn
Body weight of mother (containing BMI)
Weight of placenta
Length of umbilical cord
Time for delivery
Amount of bleeding in delivery
Apgar score

Base
Study type Interventional

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

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Omega-3 fatty acid oil (Fish oil).
1.8g as EPA and DHA daily.
Interventions/Control_2 Omega-3 fatty acid oil (Perilla oil).
1.8g as alpha-linolenic acid daily.
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

Not applicable
Gender Female
Key inclusion criteria Primiparous pregnant women of the first birth, which have taken the mother class and delivered in Sagamino hospital.
Key exclusion criteria A person with a disease.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toru Moriguchi
Organization Azabu University
Division name Laboratory of Food and Nutritional Science, Department of Food and Life Science, School of Life and Environmental Science
Zip code
Address 1-17-71 Fuchinobe, Sagamihara, Kanagawa 252-5201, Japan
TEL 042-850-2499
Email moriguchi@azabu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Toru Moriguchi
Organization Azabu University
Division name Laboratory of Food and Nutritional Science, Department of Food and Life Science, School of Life and
Zip code
Address 1-17-71 Fuchinobe, Sagamihara, Kanagawa 252-5201, Japan
TEL 042-850-2499
Homepage URL
Email moriguchi@azabu-u.ac.jp

Sponsor
Institute Azabu University
Institute
Department

Funding Source
Organization Self funding
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information
2017 Year 07 Month 06 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 Preinitiation
Date of protocol fixation
2017 Year 04 Month 03 Day
Date of IRB
Anticipated trial start date
2017 Year 07 Month 06 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 04 Month 27 Day
Last modified on
2017 Year 04 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031038

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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