Effect of oral omega-3 supplementation on intraocular pressure in normotensive adults referring to ophthalmology clinics of Golestan University of Medical Sciences
Determining the effect of omega-3 oral supplements on intraocular pressure(IOP) in patients referred to the ophthalmology clinic of 5th Azar Hospital
Design
Pre-test and post-test clinical trial, phase 3 on 47 patients
Settings and conduct
All patients referred to the ophthalmology clinic of 5 Azart Hospital will be visited by an ophthalmologist and the condition of the optic nerve head and the anterior chamber angle will be examined with a slit lamp and the intraocular pressure will be measured by a Goldman applanation tonometer.
Patients who do not have a diagnosis of glaucoma on examination and the anterior chamber angle is open with both eyes and have a normal intraocular pressure (less than 21) are included in the study.
At the time of referral, complete demographic characteristics and blood pressure, waist circumference, height, measured weight and values of Fasting blood sugar, triglycerides and HDL are recorded.
Participants/Inclusion and exclusion criteria
Outpatients referred to 5 Azar Medical Center who are over 18 years old, have no history of intraocular surgery, have normal intraocular pressure (less than 21), are candidates for study.People taking a drug that affects lipid profile or have a previous diagnosis of glaucoma are excluded from the study
Intervention groups
All patients will be prescribed an omega-3 supplement containing 1000 mg of omega-3 for 90 days.
Main outcome variables
Intraocular pressure
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201011048989N1
Registration date:2020-11-14, 1399/08/24
Registration timing:retrospective
Last update:2020-11-14, 1399/08/24
Update count:0
Registration date
2020-11-14, 1399/08/24
Registrant information
Name
Marjan Akbari Kamrani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 17 3116 3354
Email address
dr.kamrani@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-11, 1399/07/20
Expected recruitment end date
2020-11-10, 1399/08/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of oral omega-3 supplementation on intraocular pressure in normotensive adults referring to ophthalmology clinics of Golestan University of Medical Sciences
Public title
Evaluation of omega-3 oral supplementation effect on intraocular pressure
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients aged 18 years and older
Satisfaction to participate in the study
No contraindications to the use of omega-3 supplements in patients
Do not take drugs that affect the lipid profile in the study
Normal intraocular pressure (less than 21)
Exclusion criteria:
Lack of follow-up of patients during the study period
Not interested in participating in the study
History of intraocular surgery
The need for intraocular surgery, including glaucoma surgery during the study period
People who have to stop or not continue omega 3 due to the need for surgery
People who have been prescribed more therapeutic doses of omega-3s due to an nutritional illness
People who have taken omega-3 supplements before studying
Taking drugs that affect lipid profile during the study
Intraocular pressure above 21
Previous diagnosis of glaucoma
Having angle-closure glaucoma
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
47
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Golestan University of Medical Sciences
Street address
Gorgan, at the beginning of Shast Kola Road
City
Gorgan
Province
Golestan
Postal code
4934174515
Approval date
2020-10-11, 1399/07/20
Ethics committee reference number
IR.GOUMS.REC.1399.223
Health conditions studied
1
Description of health condition studied
Intraocular pressure
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Intraocular pressure
Timepoint
Measurement of intraocular pressure at the beginning of the study and 90 days after starting omega 3 supplementation
Method of measurement
Goldmann applanation tonometry
Secondary outcomes
1
Description
Body mass index
Timepoint
At beginning of the study
Method of measurement
Weight in kilograms divided by height squared in meters
2
Description
Blood pressure
Timepoint
At the beginning of the study
Method of measurement
Hand barometer
3
Description
Fasting blood sugar
Timepoint
At the beginning of the study
Method of measurement
Blood test
4
Description
Triglyceride
Timepoint
At the beginning of the study
Method of measurement
Blood test
5
Description
High-density lipoprotein cholesterol
Timepoint
At the beginning of the study
Method of measurement
Blood test
Intervention groups
1
Description
Intervention group: For all patients, omega-3 supplements will be prescribed daily for one omega-3 oral capsule of Minoo Pharmaceutical Company containing 1000 mg of omega-3 and 180 mg of echopentanoic acid and 120 mg of docosahexaenoic acid in the form of SOFT GELL.All patients are advised not to change their diet during the study.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ophthalmology Clinic of 5 Azar Hospital, Gorgan
Full name of responsible person
Marjan Kamrani
Street address
5 Azar Hospital, 5 Azar St., Gorgan,
City
Gorgan
Province
Golestan
Postal code
4917761551
Phone
+98 17 3222 0561
Fax
+98 17 3223 8363
Email
gsm@goums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Mohammad Rza Honarvar
Street address
Golestan University of Medical Sciences, At the beginning of Shast Kola Road, Gorgan,
City
Gorgan
Province
Golestan
Postal code
4934174515
Phone
+98 17 3245 0021
Email
gsm@goums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gorgan 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
Gorgan University of Medical Sciences
Full name of responsible person
Marjan Akbari Kamrani
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Ophthalmology
Street address
5th Azar Hospital, 5th Azar Blv.,Gorgan, Iran
City
Gorgan
Province
Golestan
Postal code
4917761551
Phone
+98 17 3116 3354
Fax
Email
dr.kamrani@goums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Marjan Akbari Kamrani
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Ophthalmology
Street address
5th Azar Hospital, 5th Azar Blv.,Gorgan, Iran
City
Gorgan
Province
Golestan
Postal code
4917761551
Phone
+98 17 3116 3354
Fax
Email
dr.kamrani@goums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Marjan Akbari Kamrani
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Ophthalmology
Street address
5th Azar Hospital, 5th Azar Blv.,Gorgan, Iran
City
Gorgan
Province
Golestan
Postal code
4917761551
Phone
+98 17 3116 3354
Fax
Email
dr.kamrani@goums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Information about the main outcome can be shared after people are not identified
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Study data or documentation will be provided to researchers for more extensive clinical studies after approval by the project implementers.
From where data/document is obtainable
Dr. Marjan Akbari Kamrani: dr.kamrani@goums.ac.ir
Vice Chancellor for Research and Development of Golestan University of Medical Sciences: gsm@goums.ac.ir
What processes are involved for a request to access data/document
After sending an email to the mentioned authorities and reviewing the request by the project executors, the result will be notified to the applicant via email.