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Effect of Omega 3 fatty acids and vitamin E supplementation on symptoms of primary dysmenorrhea in resident students at Ahvaz Jundishapur University of Medical Sciences student accommodation: A randomized, single-blind, placebo-controlled clinical trial

Protocol summary

Summary
This is a clinical trial for evaluation of the effects of supplementation with vitamin E and omega- 3, on 100 students between 18 and 30 years, with primary dysmenorrhea in the girls dormitory of Ahvaz University of Medical Sciences. Inclusion criteria: having primary dysmenorrhea , single, living in dormitory and exclusion criteria include irregular menstrual cycles, abnormal discharge, itching and burning. Subjects were randomly divided into four groups (using table of random numbers) consist of recipients of supplemental vitamin E, omega 3 supplement, omega 3+ Vit E and placebo group (each group 25 cases). Vitamin E 200 units will be given orally for 5 days, 2 days before and 3 days after period to take a daily pill. Patients receive omega 3 daily 300 mg of Omega 3 (180 mg docosahexaenoic acid + 120 mg eicosapentaenoic acid) and the group receiving vitamin E and omega-3 daily (5 days), vitamin E 200 units +300 mg of omega-3 (180 docosahexaenoic acid acid mg +120 mg eicosapentaenoic acid). In this study supplement and placebo were similar in appearance and patients randomized to receive supplement and placebo and will be unaware of this issue. Duration of menstruation (days), the interval between periods (days), duration of pain at each time period (day and hour) and measurement of pain through questionnaires and standard tools (visual analogue scale) will be carried out.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014102519669N1
Registration date: 2014-12-17, 1393/09/26
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-12-17, 1393/09/26
Registrant information
Name
Hossein Khadem Haghighian
Name of organization / entity
Qazvin University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 28 3375 2135
Email address
khadem.h@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2013-12-22, 1392/10/01
Expected recruitment end date
2014-06-20, 1393/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Omega 3 fatty acids and vitamin E supplementation on symptoms of primary dysmenorrhea in resident students at Ahvaz Jundishapur University of Medical Sciences student accommodation: A randomized, single-blind, placebo-controlled clinical trial
Public title
Effect of Omega 3 fatty acids and vitamin E supplementation on symptoms of primary dysmenorrhea
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: People who have primary dysmenorrheal and use irregular NSAIDS and OCP. Exclusion criteria: Patients with secondary dysmenorrhea (endometriosis, adenomyosis, leiomyoma, uterine anomaly, Endometrial Polyps, ovarian cyst).
Age
From 18 years old to 30 years old
Gender
Female
Phase
2
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
Used
Assignment
Factorial
Other design features
Qualified persons in each category will be selected with simple randomization and table of random numbers.

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Ahvaz Jundishapur University of Medical Science- Golestan Ave- َAhvaz
City
Ahvaz
Postal code
Approval date
2013-12-22, 1392/10/01
Ethics committee reference number
ajums.res.1392.358

Health conditions studied

1

Description of health condition studied
dysmenorrhoea
ICD-10 code
N94.4
ICD-10 code description
Primary dysmenorrhoea

Primary outcomes

1

Description
pain duration
Timepoint
at first and two months after intervention
Method of measurement
based on hours

Secondary outcomes

1

Description
Pain intensity
Timepoint
At first and two months after intervention
Method of measurement
Based on the VAS pain intensity

Intervention groups

1

Description
Intervention group III: vitamin E, 200 units + Omega 3, 300 mg(180 docosahexaenoic acid acid mg +120 mg eicosapentaenoic acid), Manufacturing in Zahravi pharmaceutical company, daily, two days before and three days of menstruation, two menstrual periods
Category
Treatment - Drugs

2

Description
Intervention group II: Omega 3, 300 mg(180 docosahexaenoic acid acid mg +120 mg eicosapentaenoic acid), Manufacturing in Zahravi pharmaceutical company, daily, two days before and three days of menstruation, two menstrual periods
Category
Treatment - Drugs

3

Description
Intervention group I:vitamin E, 200 units, Manufacturing in Zahravi pharmaceutical company, daily, two days before and three days of menstruation, two menstrual periods
Category
Treatment - Drugs

4

Description
Group IV: Placebo
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Dormitories of Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Hossein Khadem Haghighian
Street address
Ahvaz Jundishapur University of Medical Science, Golestan Ave. Ahvaz
City
Ahvaz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr.Saki
Street address
Ahvaz Jundishapur University of Medical Science, Golestan Ave. Ahvaz
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Ahvaz Jundishapur 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
Ahvaz Jundishapur University of Medical Science
Full name of responsible person
Dr. Sima Jafarirad
Position
Assistant Professor
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Science, Golestan Ave. Ahvaz
City
Ahvaz
Postal code
Phone
+98 61 3337 3858
Fax
Email
SJafari@ajums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Science
Full name of responsible person
Hossein Khadem Haghighian
Position
Ph.D
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Science, Golestan Ave. Ahvaz
City
Ahvaz
Postal code
Phone
+98 61 3337 3858
Fax
Email
khadem.h@ajums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Science
Full name of responsible person
Hossein Khadem Haghighian
Position
Ph.D
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Science, Golestan Ave. Ahvaz
City
Ahvaz
Postal code
Phone
00
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
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Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
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Analytic Code
empty
Data Dictionary
empty
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