UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027170 |
|---|---|
| Receipt number | 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 | 2020/04/30 18:15:19 |
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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
| Obstetrics 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 | Toru |
| Middle name | |
| Last name | 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
252-5201
Address
1-17-71 Fuchinobe, Sagamihara, Kanagawa 252-5201, Japan
TEL
042-850-2499
moriguchi@azabu-u.ac.jp
Public contact
Name of contact person
| 1st name | Toru |
| Middle name | |
| Last name | Moriguchi |
Organization
Azabu University
Division name
Laboratory of Food and Nutritional Science, Department of Food and Life Science, School of Life and
Zip code
252-5201
Address
1-17-71 Fuchinobe, Sagamihara, Kanagawa 252-5201, Japan
TEL
042-850-2499
Homepage URL
moriguchi@azabu-u.ac.jp
Sponsor or person
Institute
Azabu University
Institute
Department
Personal name
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
The Human Research Ethics Committee of Azabu University
Address
1-17-71 Fuchinobe, Sagamihara, Kanagawa 252-5201, Japan
Tel
042-754-7111
human.ethics@azabu-u.ac.jp
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
250
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
No longer recruiting
Date of protocol fixation
| 2017 | Year | 04 | Month | 03 | Day |
Date of IRB
| 2017 | Year | 04 | Month | 03 | Day |
Anticipated trial start date
| 2017 | Year | 07 | Month | 06 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
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
| 2020 | Year | 04 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031038
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
