Omega-3 consumption in premenstrual syndrome: measuring its effects on the quality of life using the Premenstrual Symptoms Screening Tool (PSST) and SF12 questionnaire
The purpose of this study is to evaluate Omega-3 consumption on quality of life of people with premenstrual syndrome using PSST and SF-12 questionnaires. In this double blind placebo controlled study, 90 students living in dormitories who meet eligibility criteria will be randomly into omega-3 or placebo group. Participants will take 2 capsules of 0mega-3 or placebo daily in the first month. They will take capsules in the second and third months since 8 days before menstruation until 2 days after onset of menstrual bleeding. PSST and SF-12 questionnaires will be filled by participants every month.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138809212843N1
Registration date:2010-04-24, 1389/02/04
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-04-24, 1389/02/04
Registrant information
Name
Fatemeh Zahra Hariri
Name of organization / entity
Tarbiat Modares University
Country
Iran (Islamic Republic of)
Phone
+98 21 8801 1001
Email address
fhariri@modares.ac.ir
Recruitment status
Recruitment complete
Funding source
Tarbiat Modares University
Expected recruitment start date
2009-05-22, 1388/03/01
Expected recruitment end date
2010-03-20, 1388/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Omega-3 consumption in premenstrual syndrome: measuring its effects on the quality of life using the Premenstrual Symptoms Screening Tool (PSST) and SF12 questionnaire
Public title
Omega-3 consumption in premenstrual syndrome: measuring its effects on the quality of life using the Premenstrual Symptoms Screening Tool (PSST) and SF12 questionnaire
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age 20-35 years, single girls, normal cycle (duration of cycle 22-35, bleeding 3-7 days), normal BMI (18.5-25), PMS according to PSST questionnaire
Exclusion criteria: any history of disease such as hepatic, renal, or respiratory cardiac, diabetes, or respiratory diseases, presence of secondary dysmenorrheal, sea food allergy, use of alcohol, smoking, presence of chronic diseases such as like migraine, use of any drug affecting PMS such as OCP or B6, stressful condition like death of family members
Age
From 20 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
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
Tarbiat Modares University
Street address
Faculty of Medicine, Tarbiat Modares University, Jalal Ale Ahmad EXP way
City
Tehran
Postal code
Approval date
2009-01-18, 1387/10/29
Ethics committee reference number
15070878
Health conditions studied
1
Description of health condition studied
Premenstrual syndrome
ICD-10 code
N94.3
ICD-10 code description
Pain and other conditions associated with female genital organs and menstrual cycle
Primary outcomes
1
Description
premenstrual syndrome (existing symptoms in PSST questionnaire
Timepoint
before intervention, 1, 2, and 3 months after intervention
Method of measurement
PSST questionnaire
2
Description
quality of life
Timepoint
before intervention, 1, 2, and 3 month after intervention
Method of measurement
SF-12 questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Omega-3, one gram capsule, twice daily, everyday in the first month and since 8 days before mentstruation till 2 days after begining of bleeding in the second and third months
Category
Treatment - Drugs
2
Description
Placebo, one gram capsule, twice daily, everyday in the first month and since 8 days before mentstruation till 2 days after begining of bleeding in the second and third months
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran &Tarbiat Modares University
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Fateme Zahra Hariri
Street address
Tarbiat Modares University, Jalal EXP way
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tarbiat Modares University
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
Tarbiat Modares University
Full name of responsible person
FatemehZahra Hariri
Position
Student
Other areas of specialty/work
Street address
Midwifery Department, Tarbiat Modares University, Jalal Ale Ahmad Expway