The purpose of study is to determine the effect of fish oil supplementation on lipid profiles of pregnant. Randomized clinical trial, In this study, researcher and researcher assistance, the analyser and the participants will be Blind. Questionnaire number one for evaluation of the inclusion criteria will be given to people who would like to participate in the study. If conditions was appropriate the second questionnaire will be given to collect demographic information and complete their pregnancy occurs. Also the third questionnaire contains a tutorial on how to use capsules, recorded weekly taking capsules and possible events will be given to pregnant women. A total of 150 samples will be selected from which 75 patients will be in the intervention group and 75 patients will be in the placebo group. The study population consisted of 18-35 years old pregnant women with first to fifth parity who have family records at health centers in Tabriz .Thus healthy 18-35 years old pregnant women with gestational age of 16-20 weeks of pregnancy with first to fifth parity, who have not been used any drug will be participate in the project. Pregnant women were randomly divided into two groups, one group receiving placebo and another group receiving fish oil supplements capsules. Consumption of fish oil capsules (1,000 mg contains of 120 mg DHA and 180 mg EPA) and placebo (same shape, the same size and weight with other capsules) daily one capsule from the end of the 20th week of pregnancy until first month of postpartum period which will be about 24 weeks (168 capsules). At the beginning of the study (20-16 weeks gestation) and in the fifth care of pregnancy (weeks 35-37) 3 cc blood samples will be collected and will be sent to the laboratory for evaluation of lipid profiles level. Sampling will be carried out as quota with the order of the number of pregnancies (first, second or more pregnancy). Main outcome measure variables is the lipid profile test.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015070523067N1
Registration date:2015-08-13, 1394/05/22
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-08-13, 1394/05/22
Registrant information
Name
Esmail Faraji
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 7850
Email address
farajie@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Endocrine Research Center, Tabriz University of Medical Sciences
Expected recruitment start date
2014-11-27, 1393/09/06
Expected recruitment end date
2015-10-28, 1394/08/06
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of fish-oil supplementation on lipid profile of pregnant mothers: a randomized controlled trial
Public title
The effect of fish-oil supplementation on lipid profile of pregnant mothers: a randomized controlled trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: willingness to participate in the study, aged 18-35 years, first to fifth pregnancy, pregnant women with 16-20weeks of gestation, single pregnancy; BMI less than 30, healthy pregnant women with no previous underlying medical condition, including heart disease, kidney, gastrointestinal, respiratory, autoimmune, diabetes, impaired glucose tolerance testing in the current pregnancy, thyroid, epilepsy, hypertension underlying psychiatric disorders, hyperlipidemia and not to use any drugs because of the above conditions
.Exclusion criteria:, bleeding, placenta previa, placenta detachment in current pregnancy, infertility and premature labor history, the existence of any history of allergy to fish or fish oil or other products or allergic to gelatin, the unfortunate incident that had occurred 6 months prior to the study, smoking or drugs, bleeding disorders or taking anticoagulants, participating in another study
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:
150
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple 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 Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences, Daneshgah Square Tabriz, Tabriz
City
Tabriz
Postal code
Approval date
2015-06-24, 1394/04/03
Ethics committee reference number
TBZMED.REC.1394.276
Health conditions studied
1
Description of health condition studied
Lipid levels in Pegnant women
ICD-10 code
094-095-09
ICD-10 code description
Other obstetric conditions, not elsewhere classified
Primary outcomes
1
Description
Lipid Profile
Timepoint
begiining of study,fifth care of pregnancy
Method of measurement
blood analysis
Secondary outcomes
empty
Intervention groups
1
Description
Group interventions: fish oil capsules (containing 120 mg of DHA and 180 mg, 1000 mg EPA) ,Every day 1 number
Category
Treatment - Drugs
2
Description
Control group: placebo (same shape, size and weight with other capsules ,Every day 1 number
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Health facilities in Tabriz
Full name of responsible person
Hossein Aslani
Street address
Imam Reza Hospital, Tabriz Department Of Internal Medicine, Tabriz University of Medical Sciences, Daneshgah Avenue, Daneshgah Square Tabriz
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Endocrine Research Center, Tabriz University of Medical Sciences
Full name of responsible person
Esmail Faraji
Street address
Endocrine Research Center,Imam Reza Hospital, Tabriz University of Medical Sciences, Daneshgah Avenue, Daneshgah Square Tabriz
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Endocrine Research Center, Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Hossein Aslani
Position
General Practitioner
Other areas of specialty/work
Street address
Imam Reza Hospital, Tabriz Department Of Internal Medicine
City
Tabriz
Postal code
Phone
+98 41 3382 3655
Fax
Email
hosseinaslani1990@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Esamail Faraji
Position
Assistant Professor of Endocrinology and Metabolic Diseases
Other areas of specialty/work
Street address
Tabriz University of Medical Sciences, Daneshgah Square, Imam Reza Hospital, Tabriz Department Of Internal Medicine
City
Tabriz
Postal code
Phone
+98 41 3335 7850
Fax
Email
farajie@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Hossein Aslani
Position
General Practitioner
Other areas of specialty/work
Street address
Imam Reza Hospital, Tabriz University of Medical Sciences, Daneshgah Avenue, Daneshgah Square Tabriz
City
Tabriz
Postal code
Phone
+98 41 3382 3655
Fax
Email
hosseinaslani1990@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)