Objective: to evaluate the effect of Omega-3 fatty acids on the treatment of premenstrual syndrome.
Method: A randomized double blind controlled trial was performed on 180 eligible women. The eligible women were randomly assigned into two groups. 120 women finally finished the study.
In the case group (Omega-3 group), Omega-3 in a dose of 2 gram (2 one gram pearls), and in the control group (placebo group ) 2 placebo pearls, which were completely similar to Omega-3 pearls, were prescribed.
The severity and duration of each of the symptoms were compared in both groups 1.5 and 3 months after the beginning of treatment.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138808122624N2
Registration date:2010-05-25, 1389/03/04
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-05-25, 1389/03/04
Registrant information
Name
Maryam Kashanian
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 7752 3487
Email address
maryamka@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2008-08-30, 1387/06/09
Expected recruitment end date
2009-02-27, 1387/12/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of Omega-3 fatty acids on the treatment of premenstrual syndrome
Public title
Effect of Omega-3 fatty acids on premenstrual syndrome
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Age between 20-45, educational status of more than diploma, regular & normal menstruation, BMI= 19-26, and having premenstrual syndrome.
Exclusion criteria: pregnancy and lactation, primary and secondary amenorrhea, any history of psychological disorders, any drug use, using contraceptive pills, allergy to omega-3, history of coagulopathy, and using food supplements, history of dramatic events like marriage, death of relatives and surgery during last 3 months.
Age
From 20 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
123
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
Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Hemmat Highway
City
Tehran
Postal code
Approval date
2008-02-05, 1386/11/16
Ethics committee reference number
5869
Health conditions studied
1
Description of health condition studied
Premenstrual syndrome
ICD-10 code
n94.3
ICD-10 code description
Premenstrual tension syndrome
Primary outcomes
1
Description
somatic sign of premenstrual syndrome
Timepoint
1.5 and 3 months later
Method of measurement
questionnare
2
Description
psychiatric sign of premenstrual syndrome
Timepoint
1.5 & 3 months
Method of measurement
questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Omega3 prescription, 2 gram/daily
Category
Treatment - Drugs
2
Description
Plecebo prescription
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
hospitals of Iran University of Medical Sciences
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Investigator
Full name of responsible person
Dr. Maryam Kashanian
Street address
Iran University of Medical Sciences, Faculty of Medicine
City
Tehran
Grant name
---------
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Investigator
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
Iran University of Medical Sciences
Full name of responsible person
Maryam Kashanian
Position
Associate professor
Other areas of specialty/work
Street address
No 9, Mostaghimi Alley, Khajeh Nasir Toosi Avenue.
City
Tehran
Postal code
16117
Phone
+98 21 7752 3487
Fax
Email
maryamkashanian@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Maryam Kashanian
Position
Associate professor
Other areas of specialty/work
Street address
No 9, Mostaghimi Alley, Khajeh Nasir Toosi Avenue.
City
Tehran
Postal code
16117
Phone
+98 21 7752 3487
Fax
Email
maryamkashanian@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Maryam Kashanian
Position
Associate professor
Other areas of specialty/work
Street address
No 9, Mostaghimi Alley, Khajeh Nasir Toosi Avenue.
City
Tehran
Postal code
16117
Phone
+98 21 7752 3487
Fax
Email
maryamkashanian@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)