The objective of this study was to evaluate the effect of fish oil in oxidative stress indexes in healthy pregnant women. The patients were allocated into intervention or control method using block randomization method. The patients in the intervention group received 1000 mg fish oil as capsules (180mg EPA, 129mg DHA) daily since 16th gestational week of pregnancy until delivery. No intervention was recommended for the control group. Serum lipid peroxide, thiol group, and FRAP (Ferric reducing antioxidant plasma) was evaluated at gestational week 37-40.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138902091557N3
Registration date:2010-05-29, 1389/03/08
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-05-29, 1389/03/08
Registrant information
Name
Katayon Vakilian
Name of organization / entity
Arak University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 86 1417 3502
Email address
k_vakili@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Arak University of Medical Sciences and Health Services
Expected recruitment start date
2008-02-19, 1386/11/30
Expected recruitment end date
2008-10-21, 1387/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of fish oil in oxidative stress indices in healthy pregnant women
Public title
The effect of fish oil in oxidative stress indices in healthy pregnant women
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: singleton pregnancy, age between 18-40, any acute or chronic diseases, prenatal care before 16th gestational week
Exclusion criteria: Irregular or no consumption of omega 3, discountinued prenatal care, smoking
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Arak University of Medical Sciences and Health Services
Street address
Arak University of Medical Sciences and Health Services, Sardasht st.
City
Arak
Postal code
Approval date
2007-11-28, 1386/09/07
Ethics committee reference number
266
Health conditions studied
1
Description of health condition studied
Abnormal findings on antenatal screening of mother
ICD-10 code
O28.1
ICD-10 code description
Abnormal biochemical finding on antenatal screening of mother
Primary outcomes
1
Description
lipid peroxide
Timepoint
38th week of pregnancy
Method of measurement
5 cc of venous blood
2
Description
The ability of plasma to reduce the Ferric Ions to the Ferro
Timepoint
38th week of pregnancy
Method of measurement
5 cc of venous blood
Secondary outcomes
1
Description
Thiol group
Timepoint
38th week of pregnancy
Method of measurement
5 cc of venous blood
Intervention groups
1
Description
Omega 3, 1000mg (one capsule), since 16th week pregnancy to termination (week 40)
Category
Treatment - Drugs
2
Description
No supplementation
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Taleghani Hospital, Arak University of Medical Sciences and Health Services
Full name of responsible person
Street address
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences and Health Services
Full name of responsible person
Katayon Vakilian
Street address
Nursing and Midwifery collage, Arak University of Medical Sciences and Health Services, Sardasht st.
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak University of Medical Sciences and Health Services
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
Arak University of Medical Sciences and Health Services
Full name of responsible person
Katayon Vakilian
Position
Master SCience degree of midwiferry
Other areas of specialty/work
Street address
Nursing and Midwifery collage, Arak University of Medical Sciences and Health Services, Sardasht st.
City
Arak
Postal code
Phone
+98 86 1417 3502
Fax
Email
k_arakmu.ac.ircattyv2002@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences and Health Services
Full name of responsible person
Katayon Vakilian
Position
Faculty Member
Other areas of specialty/work
Street address
Nursing and Midwifery collage, Arak University of Medical Sciences and Health Services, Sardasht st.
City
Arak
Postal code
Phone
+98 86 1417 3502
Fax
Email
K_vakili@arakmu.ac.ir cattyv2002@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)