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Oleoylethanolamide (OEA) supplementation effect on oxidative stress, prostaglandins, inflammatory factors and symptoms of primary dysmenorrhea in dormitory students in Qazvin University of Medical Sciences: A double-blind controlled clinical trial with placebo

Protocol summary

Study aim
The determination of antioxidant status, inflammatory factors and symptoms of primary dysmenorrhea in patients with primary dysmenorrhea
Design
In this study, 44 girls with primary dysmenorrhea who eligible for inclusion in the study and reside in dormitories of the Qazvin University of Medical Sciences are selected. Participants are randomly assigned to two intervention and control groups and each participant is assigned a code.
Settings and conduct
This study will be done by referring to the dormitories of the Qazvin University of Medical Sciences. The intervention and control group will receive 120 mg of Oleoylethanolamide or placebo daily for 2 months, respectively. Each person will complete questionnaires of consent, individual, physical activity, and 24-hour recall. Fasting blood samples were also collected at the beginning and end of the study in 10 ml from participants. In this study, participants will be randomly divided into two groups (22 persons) through the table of random numbers.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Having primary dysmenorrhea, having regular menstruation between 35-21 days, single, having a body mass index below 30 Exclusion criteria: Having secondary dysmenorrhea (endometriosis, adenomyosis, leiomyoma, uterine anomaly, Endometrial Polyps, ovarian cyst), intake of antioxidant supplement in the last six months, intake of fatty acids supplements in the last six months
Intervention groups
Intervention group: the group receiving Oleoylethanolamide (125 mg daily) Control group: placebo group
Main outcome variables
Oxidative stress indices, concentration of prostaglandins, inflammatory factors duration of bleeding, pain intensity of menstruation, duration of pain

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20141025019669N14
Registration date: 2019-10-14, 1398/07/22
Registration timing: registered_while_recruiting

Last update: 2019-10-14, 1398/07/22
Update count: 0
Registration date
2019-10-14, 1398/07/22
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
Expected recruitment start date
2019-10-12, 1398/07/20
Expected recruitment end date
2019-12-21, 1398/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Oleoylethanolamide (OEA) supplementation effect on oxidative stress, prostaglandins, inflammatory factors and symptoms of primary dysmenorrhea in dormitory students in Qazvin University of Medical Sciences: A double-blind controlled clinical trial with placebo
Public title
Oleoylethanolamide (OEA) supplementation effect on symptoms of dysmenorrhea
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having primary dysmenorrhea Having regular menstruation between 35-21 days Single Having a body mass index below 30
Exclusion criteria:
Having secondary dysmenorrhea (endometriosis, adenomyosis, leiomyoma, uterine anomaly, Endometrial Polyps, ovarian cyst) Intake of antioxidant supplement in the last six months Intake of fatty acids supplements in the last six months
Age
From 18 years old to 25 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 44
Randomization (investigator's opinion)
Randomized
Randomization description
It will be done randomly using the lottery method. Each patient will receive a number or code, and then we will write the numbers on pieces of paper. We will then place the pieces of paper in a container and select the samples according to the sample size.
Blinding (investigator's opinion)
Double blinded
Blinding description
Supplements and placebo will be placed in similar containers and encode by someone except investigator, so patients and the investigator will be blinded to medicine and placebo groups.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Qazvin University Of Medical Sciences
Street address
Qazvin University of Medical Science, Shahid Bahonar Blvd, Qazvin
City
Qazvin
Province
Qazvin
Postal code
34197-59811
Approval date
2019-08-10, 1398/05/19
Ethics committee reference number
IR.QUMS.REC.1398.100

Health conditions studied

1

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

Primary outcomes

1

Description
Total antioxidant capacity
Timepoint
Before the intervention and after the intervention
Method of measurement
Eliza

2

Description
Malondialdehyde
Timepoint
Before the intervention and after the intervention
Method of measurement
Eliza

3

Description
E2 prostaglandin
Timepoint
Before the intervention and after the intervention
Method of measurement
Eliza

4

Description
F2α prostaglandin
Timepoint
Before the intervention and after the intervention
Method of measurement
Eliza

5

Description
Inflammatory factors
Timepoint
Before the intervention and after the intervention
Method of measurement
Eliza

6

Description
Duration of bleeding
Timepoint
Before the intervention and after the intervention
Method of measurement
According to a person's report by the questionnaire

7

Description
Pain duration
Timepoint
Before the intervention and after the intervention
Method of measurement
Duration of pain based on questionnaire

8

Description
Intensity of pain
Timepoint
Before the intervention and after the intervention
Method of measurement
Pain intensity according to the questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Oleoylethanolamide, a capsule 120 mg per daily for two months, Manufacturer: Supplement Spot
Category
Treatment - Drugs

2

Description
Control group: A daily placebo capsule containing wheat flour for two months
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Qazvin University of Medical Sciences
Full name of responsible person
Hossein Khadem Haghighian
Street address
Qazvin University of Medical Science, Shahid Bahonar Blvd, Qazvin
City
Qazvin
Province
Qazvin
Postal code
34197-59811
Phone
+98 28 3333 6001
Email
khademnut@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr. Peimani
Street address
Qazvin University of Medical Science, Shahid Bahonar Blvd, Qazvin
City
Qazvin
Province
Qazvin
Postal code
34197-59811
Phone
+98 28 3333 6001
Email
khademnut@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Hossein Khadem Haghighian
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Qazvin University of Medical Science, Shahid Bahonar Blvd, Qazvin
City
Qazvin
Province
Qazvin
Postal code
34197-59811
Phone
+98 28 3333 6001
Email
khademnut@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Hossein Khadem Haghighian
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Qazvin University of Medical Science, Shahid Bahonar Blvd, Qazvin
City
Qazvin
Province
Qazvin
Postal code
59811 -34197
Phone
+98 28 3333 6001
Email
khademnut@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Hossein Khadem Haghighian
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Qazvin University of Medical Science, Shahid Bahonar Blvd, Qazvin
City
Qazvin
Province
Qazvin
Postal code
34197-59811
Phone
+98 28 3333 6001
Email
khademnut@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data after people are unrecognizable
When the data will become available and for how long
After completing the study and analyzing the data
To whom data/document is available
All researchers
Under which criteria data/document could be used
There is no objection to the use of data provided the source of the resource.
From where data/document is obtainable
By contacting the email address of a person responsible for general inquiries khademnut@yahoo.com
What processes are involved for a request to access data/document
Six months after the study
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