The purpose of this triple blind placebo controlled randomized is to investigate the effect of Omega3 in the treatment of hot flash. Study population are 80 menopausal women (40 women in each intervention and control group) are referred to Public Health centers affiliated to Zanjan University of Medical Sciences & Health Services, were randomly assigned to receive omega3 or placebo 1000 mg capsules once daily for 2 months. Main outcome measures are frequency and severity of Hot flash and Night sweating measured by Questionnaire of full medical history and Diary Card of frequency and severity of hot flash and night sweat and Questionnaire of Food Frequency before and after the intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138903224253N1
Registration date:2010-07-01, 1389/04/10
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-07-01, 1389/04/10
Registrant information
Name
Razieh Moghadam
Name of organization / entity
The International Branch of Shahid Beheshti University of Medical Sciences & Health Public
Country
Iran (Islamic Republic of)
Phone
+98 24 1424 3345
Email address
razieh.moghadam@azu.ac.ir
Recruitment status
Recruitment complete
Funding source
The International Branch of Shahid Beheshti University of Medical Sciences & Health Services
Expected recruitment start date
2010-07-01, 1389/04/10
Expected recruitment end date
2010-12-01, 1389/09/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Omega3 on Vasomotor Disorders in Menopausal Women
Public title
Effect of Omega3 on Hot flash
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria : Iranian nationality, being literate, age 45-60 years, post menopausal females (no periods for over 12 months), reporting at least two times hot flashes per day
Exclusion criteria: Receiving hormone therapy , having any known diseases such as (diabetes, cardiovascular diseases, hypertension, thyroid diseases, liver diseases, blood diseases, cancer, reflux), consumption of drugs such as anticoagulants, sedatives, alfa-adrenergic agonists such as clonidine, supplements such as soya, black cohosh, flaxeed, prime rose oil, or vitamin E, consumption of more than 2 servings of fish per weeks, hypersensitivity to fish or fish oil
Age
From 45 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
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
The International Branch of Shahid Beheshti University of Medical Sciences & Health services
Street address
No 19, Shahid Abaspoorst, next to Shahid Hammat Bridge
City
Tehran
Postal code
3693-14155
Approval date
empty
Ethics committee reference number
901/116
Health conditions studied
1
Description of health condition studied
Vasomotor Disorders
ICD-10 code
Z76.9
ICD-10 code description
Person encountering health services in unspecified circumstances
Primary outcomes
1
Description
Hot flash and Night sweat
Timepoint
Two weeks before study and everyday during the study period
Method of measurement
Questionnaires, Dairy cards
Secondary outcomes
1
Description
Kinds of food concumption and Food frequency
Timepoint
Before, at the middle, and after the intervention
Method of measurement
Food Frequency Questionairre
Intervention groups
1
Description
Omega3 Capsules, 1mg, daily, for two months
Category
Treatment - Drugs
2
Description
Placebo cap, 1mg, daily, for two months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Public Health centres affiliated to Zanjan University of Medical Sciences
Full name of responsible person
Razieh Moghadam
Street address
No 147, Bahar Ave., Sady Shomaly Street, Zanjan, Iran
City
Zanjan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
The International Branch of Shahid Beheshti Univercity of Medical Sciences & Health services
Full name of responsible person
Dr. Ghanati, Research Manager
Street address
No 19, Shahid Abaspoorst, next to Shahid Hammat Bridge
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The International Branch of Shahid Beheshti Univercity of Medical Sciences & 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
The International Branch of Shahid Beheshti University of Medical Sciences & Health Services
Full name of responsible person
Razieh Moghadam
Position
Midwifery Master student of the International Branch of Shahid Beheshti University of Medical Scienc
Other areas of specialty/work
Street address
No 19, Shahid Abaspoorst, next to Shahid Hammat Bridge
City
Tehran
Postal code
14155-3693
Phone
+92 1882 09020
Fax
+98 21 8864 9181
Email
kian.ghanati@yahoo.com
Web page address
www.ivbs.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
The International Branch of Shahid Beheshti University of Medical Sciences & Health Services
Full name of responsible person
Giti Ozgoli
Position
Academic faculty member
Other areas of specialty/work
Street address
Department of Midwifery, Faculty of Nursing-Midwifery Shahid Beheshty University of Medical Sciences and Health Services
City
Tehran
Postal code
Phone
+98 21 8820 9020
Fax
Email
gozgoli@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
The International Branch of Shahid Beheshti University of Medical Sciences & Health Services
Full name of responsible person
Razieh Moghadam
Position
Midwifery Master Student
Other areas of specialty/work
Street address
No 19, Shahid Abaspoorst, next to Shahid Hammat Bridge
City
Tehran
Postal code
14155-3693
Phone
+98 21 8820 9020
Fax
+98 21 8864 9181
Email
kian.ghanati@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)