Protocol summary

Summary
The aim of this study is to test the effect of maternal supplementation of omega-3 fatty acids during first six month of lactation on postpartum depression and serum homocysteine levels of mothers and growth and development of their infants. This study is a double-blind placebo-controlled randomized trials. The inclusion criteria are lactating women who have moderate depression and term birth. The exclusion criteria are lactating women who have severe depression and preterm birth. The sample size consist of 70 lactating women that randomly divided into two groups of 35 women: the treatment group and control group. The intervention consist of maternal supplementation containing 1 gram gel capsules of omega-3 fatty acids daily for 3 months. The control group receive gel capsules of paraffin oil as placebo daily for 3 months. The maternal outcomes of serum homocysteine and postpartum depression will be evaluated before and after the intervention. The outcomes of growth and development of the infants will be evaluated before and after the intervention as well.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015100313678N6
Registration date: 2016-03-01, 1394/12/11
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-03-01, 1394/12/11
Registrant information
Name
Saeed Ghavamzadeh
Name of organization / entity
Urmia University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 44 1278 0803
Email address
ghavamzadeh_s@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Uremia University of Medical Sciences
Expected recruitment start date
2015-10-01, 1394/07/09
Expected recruitment end date
2015-10-22, 1394/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison effect of omega-3 supplementation on postpartum depression and serum homocysteine of lactating women and growth and development of their infants
Public title
Effect of omega3 supplementation during lactation on postpartum depression and growth and development of infant
Purpose
Supportive
Inclusion/Exclusion criteria
Including criteria: lactating women who have moderate depression; have singleton and term birth; have no complicated pregnancy and labor; have no history of depression and use antidepressants or anticoagulants; age of mother between 18-35; weight of infants above 2500 grams. Excluding criteria: lactating women who have severe depression; have preterm birth and twins; have chronic diseases such as blood pressure and diabetes; have complicated pregnancy and labor; ages of mothers under 18 years old and above 35 years old.
Age
From 18 years old to 35 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 70
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
Uremia University of Medical Sciences
Street address
Uremia University of Medical Sciences
City
Uremia
Postal code
57147-83734
Approval date
2015-09-02, 1394/06/11
Ethics committee reference number
Ir.umsu.rec.1394.180

Health conditions studied

1

Description of health condition studied
Postpartum depression
ICD-10 code
F53
ICD-10 code description
Pregnancy; childbirth and the puerperium

Primary outcomes

1

Description
Postpartum depression
Timepoint
Before and after intervention
Method of measurement
Edinburgh Postpartum Depression Scales - Beck Depression Inventory

2

Description
Homocysteine
Timepoint
Before and after intervention
Method of measurement
Blood Samples

3

Description
Infants growth
Timepoint
Monthly
Method of measurement
Weight, height,head circumstances

4

Description
Development
Timepoint
4 and 6 month after birth
Method of measurement
Ages and Stages Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Treatment group; omega3 one gram daily for 3 months
Category
Treatment - Drugs

2

Description
Controls groups; Paraffin oil daily for 3 months
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Health Centers
Full name of responsible person
Street address
Ardebil
City
Ardebil

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Student
Full name of responsible person
Nasrin Nazeri
Street address
Uremia university of Medical Science
City
Uremia
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Student
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

Person responsible for scientific inquiries

Contact
Name of organization / entity
Uremia University of Medical Sciences
Full name of responsible person
Dr Saeiad Ghavamzadeh
Position
Nutritionist
Other areas of specialty/work
Street address
Uremia University of Medical Sciences
City
Uremia
Postal code
Phone
+98 44 3223 4897
Fax
Email
Ghavamzadeh @hotmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Uremia University of Medical Science
Full name of responsible person
Nasrin Nazeri
Position
MS student of nutrition
Other areas of specialty/work
Street address
Uremia University of Medical Science
City
Uremia
Postal code
5714783738
Phone
00
Fax
Email
nasrin.nazeri11@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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