The aim of this study was to investigate the effect of omega3 fatty acid capsules during pregnancy depressionprimi gravidia woman from 18 years old attending the selected health clinics of Shiraz university of medical sciences which had agreed to cooperate with the researchers. In case the study subject sufferd from any ilness, were not willing to continue participating in the study, and showed allergic reactions to medication, they were excluded from the study. After all, a total of 80subjects were entered into the study and randomly divided into 2 groups receiving the drug, , and placebo, respectively for 6 weeks was evaluated with using Beck Depression inventory.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012121011717N1
Registration date:2013-01-08, 1391/10/19
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-01-08, 1391/10/19
Registrant information
Name
Laleh Saniee
Name of organization / entity
Fatemeh (PBUH) College of Nursing and Midwifery, Shir
Country
Iran (Islamic Republic of)
Phone
+98 71 1235 4449
Email address
sanieel@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research office, Shiraz University Of Medical Sciences
Expected recruitment start date
2012-07-07, 1391/04/17
Expected recruitment end date
2013-01-06, 1391/10/17
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of omega3 fatty acid capsules on primi gravida during pregnancy depression that refer to health clinic in shiraz, Iran
Public title
The effect of omega3 fatty acid capsules on primi gravida during pregnancy depression
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: willingness to participate; primi gravidia woman from 18 years old; not having disease such as heart disease, hyperthyroidism, hypothyroidism, renal infection and diabetes mellitus; not taking any medication that effect depression such as anti depressent, SRII; no familial disorder; no psychotic problem and no psychotic consultation. Exclusion criteria: unwillingness to cooperate after the beginning of the study and showing allergic reaction to omega3.
Age
From 18 years old to 44 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Central builingof Shiraz University of Medical Sciences, Zand Street, Shiraz
City
Shiraz
Postal code
7188833398
Approval date
2012-07-07, 1391/04/17
Ethics committee reference number
91-611
Health conditions studied
1
Description of health condition studied
depression
ICD-10 code
F32.0
ICD-10 code description
episode-depressive-mild
Primary outcomes
1
Description
Depression
Timepoint
At the start of intervention- After intervention
Method of measurement
Beck depression inventory
Secondary outcomes
empty
Intervention groups
1
Description
Intervention withomega 3capsules for each patient 1000 mg/day in 6weeks.
Category
Treatment - Drugs
2
Description
placebo capsules are used 1 per day for 6 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Parseh health clinic
Full name of responsible person
Masumeh Kaviani
Street address
Sadra
City
Shiraz
2
Recruitment center
Name of recruitment center
Talegani health clinic
Full name of responsible person
Masumeh Kaviani
Street address
Modares bolvar
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Shiraz University of Medical Sciences
Full name of responsible person
Dr. Gholam Reza Hatam
Street address
7th Flat, Central building of Shiraz University of Medical Sciences, Zand Street, Shiraz
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Fatemeh (PBUH) College of Nursing and Midwifery Shira
Full name of responsible person
kavianimasumeh
Position
Faculty Member, MSc in Midwifery
Other areas of specialty/work
Street address
Namazi square, Shiraz
City
shiraz
Postal code
kavianm@sums.ac.ir
Phone
+98 71 1647 4252
Fax
+98 71 1647 4252
Email
kavianm@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Fatemeh (PBUH) College of Nursing and Midwifery Shiraz University of Medical Sciences
Full name of responsible person
Masumeh Kaviani
Position
Faculty Member, MSc in Midwifery
Other areas of specialty/work
Street address
Namazi square, Shiraz
City
Shiraz
Postal code
Phone
+98 71 1647 4252
Fax
+98 71 1647 4252
Email
kavianm@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Fatemeh (PBUH) College of Nursing and Midwifery, Shiraz
Full name of responsible person
saniee laleh
Position
Student,Msc in Midwifery
Other areas of specialty/work
Street address
Namazi Sq
City
shiraz
Postal code
iran
Phone
+98 71 1647 4252
Fax
+98 71164748252
Email
sanieel@sums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)