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The effect of Omega-3 supplementation on Inflammatory biomarkers and total Blood cell counts of Patients with Covid-19

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History
# Registration date Revision Id
2 2022-07-19, 1401/04/28 234172
1 2021-06-13, 1400/03/23 186333
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  • Protocol summary

    This study will be performed in Imam Khomeini and Tajrish Martyrs hospitals in Tehran.The intervention group received omega-3 supplements for two weeks and the control group received the same number of placebo.The evaluation of variables is done at the beginning and end of the study by sampling the patient's blood.
    This study will be performed in shariati hospital in Tehran.The intervention group received omega-3 supplements for two weeks and the control group received the same number of placebo.The evaluation of variables is done at the beginning and end of the study by sampling the patient's blood.
    این مطالعه در بیمارستان های امام خمینی و شهدای تجریش شهر تهران انجام خواهد شد.افراد گروه مداخله به مدت دو هفته مکمل امگا-3 و گروه کنترول با همان تعداد دارونما دریافت می کنند. .ارزیابی متغیرها در ابتدا و انتهای مطالعه با نمونه گیری خون بیمار انجام می شود.
    این مطالعه در بیمارستان شریعتی شهر تهران انجام خواهد شد.افراد گروه مداخله به مدت دو هفته مکمل امگا-3 و گروه کنترول با همان تعداد دارونما دریافت می کنند. .ارزیابی متغیرها در ابتدا و انتهای مطالعه با نمونه گیری خون بیمار انجام می شود.
    Inclusion criteria: 1. Being 20 to 50 years old 2. Detection of COVID-19 based on PCR test 3. Willingness to participate in the study 4. Covid 19 patients without underlying disease (in consultation with the consultant) Criteria for not entering: 1. Breastfeeding and pregnancy 2. Advanced respiratory distress syndrome leading to intubation 3. Patients with coagulation disorders Exclusion criteria: 1. Taking antioxidant supplements while studying 2. Incidence of coagulation disorders during the study
    Inclusion criteria: 1. Being 20 to 65 years old 2. Detection of COVID-19 based on PCR test 3. Willingness to participate in the study 4. Covid 19 patients without underlying disease (in consultation with the consultant) Criteria for not entering: 1. Breastfeeding and pregnancy 2. Advanced respiratory distress syndrome leading to intubation 3. Patients with coagulation disorders Exclusion criteria: 1. Taking antioxidant supplements while studying 2. Incidence of coagulation disorders during the study
    معیار های ورود: 1.داشتن سن 20 الی 50 سال 2.تشخیص COVID-19 بر اساس تست PCR 3.تمایل به شرکت در مطالعه 4.بیماران کووید 19 بدون بیماری زمینه ای ( با مشورت استاد مشاور ) معیار های عدم ورود: 1.شیردهی و بارداری 2.سندرم زجر تنفسی پیشرفته منجر شونده به انتوباسیون 3.بیماران دچار اختلالات انعقادی معیارهای خروج از مطالعه: 1.مصرف مکمل های آنتي اکسيدانی در حین مطالعه 2.بروز اختلالات انعقادی در حین مطالعه
    معیار های ورود: 1.داشتن سن 20 الی 65 سال 2.تشخیص COVID-19 بر اساس تست PCR 3.تمایل به شرکت در مطالعه 4.بیماران کووید 19 بدون بیماری زمینه ای ( با مشورت استاد مشاور ) معیار های عدم ورود: 1.شیردهی و بارداری 2.سندرم زجر تنفسی پیشرفته منجر شونده به انتوباسیون 3.بیماران دچار اختلالات انعقادی معیارهای خروج از مطالعه: 1.مصرف مکمل های آنتي اکسيدانی در حین مطالعه 2.بروز اختلالات انعقادی در حین مطالعه

  • General information

    50
    65
    2021-10-23, 1400/08/01
    2022-10-23, 1401/08/01
    empty
    Greetings and courtesy, due to the decrease in the number of patients with covid-19, the decrease in the number of hospitalized patients and the lack of timely receipt of interventional supplements and placebos, I request that the age of patients be increased to 65 years and the end date of sampling be changed to 08/01/1401 Thank you for your efforts and cooperation.
    empty
    سلام و عرض ادب با توجه به کاهش تعداد بیماران مبتلا به کووید19، کاهش تعداد بیماران بستری بخش و عدم دریافت به موقع مکمل و دارونمای مداخله تقاضا دارم که سن بیماران تا 65 سال افزایش یابد و تاریخ خاتمه نمونه گیری به 1401/08/01 تغییر یابد.از زحمات و همکاری شما سپاس گزارم.
    Being 20 to 50 years old
    Detection of COVID-19 based on PCR test
    Willingness to participate in the study
    Covid 19 patients without underlying disease (in consultation with the consultant)
    Being 20 to 65 years old
    Detection of COVID-19 based on PCR test
    Willingness to participate in the study
    Covid 19 patients without underlying disease (in consultation with the consultant)
    داشتن سن 20 الی 50 سال
    تشخیص COVID-19 بر اساس تست PCR
    تمایل به شرکت در مطالعه
    بیماران کووید 19 بدون بیماری زمینه ای ( با مشورت استاد مشاور )
    داشتن سن 20 الی 65 سال
    تشخیص COVID-19 بر اساس تست PCR
    تمایل به شرکت در مطالعه
    بیماران کووید 19 بدون بیماری زمینه ای ( با مشورت استاد مشاور )

  • Recruitment centers

    #1
    Name of recruitment center - English: Imam Khomeini Medical, Educational and Treatment Center
    Name of recruitment center - Persian: مرکز پزشکی، آموزشی و درمانی امام خمینی
    Full name of responsible person - English: Dr. Fereshteh Ghiasvand
    Full name of responsible person - Persian: دکتر فرشته غیاثوند
    Street address - English: Iran, Tehran, Keshavarz Boulevard, Imam Khomeini Medical, Educational and Medical Center
    Street address - Persian: ایران، تهران، بلوار کشاورز، مرکز پزشکی، آموزشی و درمانی امام خمینی
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1419733141
    Phone: +98 21 6119 0000
    Fax:
    Email: Imamhospital@tums.ac.ir
    Web page address:
    Name of recruitment center - English: Shariati Medical, Educational and Treatment Center
    Name of recruitment center - Persian: مرکز پزشکی، آموزشی و درمانی شریعتی
    Full name of responsible person - English: Dr. Mona Talaschian
    Full name of responsible person - Persian: دکتر مونا طلسچیان
    Street address - English: Iran, Tehran, North kargar,Shariati Medical, Educational and Medical Center
    Street address - Persian: ایران، تهران، کارگر شمالی، مرکز پزشکی، آموزشی و درمانی شریعتی
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1411713135
    Phone: +98 21 8490 1000
    Fax:
    Email: shariatihosp@tums.ac.ir
    Web page address:
    #2
    Name of recruitment center - English: Tajrish Martyrs Medical, Educational and Medical Center
    Name of recruitment center - Persian: مرکز پزشکی، آموزشی و درمانی شهدای تجریش
    Full name of responsible person - English: Dr. Reza Jalili khoshnoud
    Full name of responsible person - Persian: دکتر رضا جلیلی خوشنود
    Street address - English: Iran - Tehran - Tajrish Square - Tajrish Martyrs Medical, Educational and Medical Center
    Street address - Persian: ایران - تهران - میدان تجریش - مرکز پزشکی، آموزشی و درمانی شهدای تجریش
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1989934148
    Phone: +98 21 25719
    Fax:
    Email: Pr_shohada@sbmu.ac.ir
    Web page address: http://shmc.sbmu.ac.ir/index.jsp?fkeyid=&siteid=90&pageid=47435
    Name of recruitment center - English: Shariati Medical, Educational and Medical Center
    Name of recruitment center - Persian: مرکز پزشکی، آموزشی و درمانی شریعتی
    Full name of responsible person - English: Dr. Keivan Gohari Moghadam
    Full name of responsible person - Persian: دکتر کیوان گوهری مقدم
    Street address - English: Iran - Tehran - North Kargar - Shariati Medical, Educational and Medical Center
    Street address - Persian: ایران - تهران - کارگر شمالی - مرکز پزشکی، آموزشی و درمانی شریعتی
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1411713135
    Phone: +98 21 8490 1000
    Fax:
    Email: shariatihosp@tums.ac.ir
    Web page address:

Protocol summary

Study aim
Determining the effect of omega-3 supplementation on inflammatory activity and blood cell status in patients with COVID-19
Design
This study will be a randomized double-blind randomized controlled clinical trial with 40 patients with COVID-19. The subjects will be assigned to the intervention group and the placebo group by block randomization method.
Settings and conduct
This study will be performed in shariati hospital in Tehran.The intervention group received omega-3 supplements for two weeks and the control group received the same number of placebo.The evaluation of variables is done at the beginning and end of the study by sampling the patient's blood.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1. Being 20 to 65 years old 2. Detection of COVID-19 based on PCR test 3. Willingness to participate in the study 4. Covid 19 patients without underlying disease (in consultation with the consultant) Criteria for not entering: 1. Breastfeeding and pregnancy 2. Advanced respiratory distress syndrome leading to intubation 3. Patients with coagulation disorders Exclusion criteria: 1. Taking antioxidant supplements while studying 2. Incidence of coagulation disorders during the study
Intervention groups
Intervention group: includes 20 patients with COVID-19 who, in addition to their usual treatments, will take 3 capsules of 1000 mg omega-3 daily for 2 weeks (14 days). Control group: includes 20 patients with COVID-19 who, in addition to their usual treatments, will take 3 placebo capsules (liquid oil) daily for 2 weeks.
Main outcome variables
CRP;ESR:IL-6;CBC DIFF

General information

Reason for update
Greetings and courtesy, due to the decrease in the number of patients with covid-19, the decrease in the number of hospitalized patients and the lack of timely receipt of interventional supplements and placebos, I request that the age of patients be increased to 65 years and the end date of sampling be changed to 08/01/1401 Thank you for your efforts and cooperation.
Acronym
IRCT registration information
IRCT registration number: IRCT20210522051363N1
Registration date: 2021-06-13, 1400/03/23
Registration timing: prospective

Last update: 2022-07-22, 1401/04/31
Update count: 1
Registration date
2021-06-13, 1400/03/23
Registrant information
Name
Keianoush Karami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 74 3233 2579
Email address
kianoushkarami91@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-23, 1400/06/01
Expected recruitment end date
2022-10-23, 1401/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Omega-3 supplementation on Inflammatory biomarkers and total Blood cell counts of Patients with Covid-19
Public title
The effect of Omega-3 supplementation in Covid-19
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Being 20 to 65 years old Detection of COVID-19 based on PCR test Willingness to participate in the study Covid 19 patients without underlying disease (in consultation with the consultant)
Exclusion criteria:
Breastfeeding and pregnancy Advanced respiratory distress syndrome leading to intubation Patients with coagulation disorders
Age
From 20 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
The block randomization method will be used so that 10 blocks of 4 people including 2 people in the intervention group and 2 people in the placebo group will be formed and assigned. The method of placing people in each block will be using a table of random numbers so In the table of random numbers from top to bottom, even numbers will be assigned to the intervention group and odd numbers to the placebo group.
Blinding (investigator's opinion)
Double blinded
Blinding description
The treating physician and nurses are part of the uninformed study groups. The patient is unaware of the study groups. The researcher is unaware of the study groups. The data analyzer is unaware of the study groups. Assignment of patients in the drug and placebo groups is done by a nurse outside the above groups.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee in Medical School Research - Tehran University of Medical Sciences
Street address
Keshavarz Boulevard, corner of Ghods, central headquarters of Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
3439123900
Approval date
2021-05-31, 1400/03/10
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1400.191

Health conditions studied

1

Description of health condition studied
Covid-19
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Serum levels of interleukin-6
Timepoint
Beginning and end of the study
Method of measurement
Blood test

2

Description
Serum levels of blood cells
Timepoint
Beginning and end of the study
Method of measurement
Blood test

3

Description
Serum levels of reactive protein-C
Timepoint
Beginning and end of the study
Method of measurement
Blood test

4

Description
Serum levels of erythrocyte sedimentation rate
Timepoint
Beginning and end of the study
Method of measurement
Blood test

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Includes 20 patients with COVID-19 who, in addition to their usual treatments, will take 3 1000 mg omega-3 capsules daily for 2 weeks (14 days).
Category
Treatment - Drugs

2

Description
Control group: Includes 20 patients with COVID-19 who, in addition to their usual treatments, will take 3 placebo capsules (liquid oil) daily for 2 weeks (14 days). Placebo capsules are very similar in appearance, color, smell and shape to omega-3 capsules.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Shariati Medical, Educational and Treatment Center
Full name of responsible person
Dr. Mona Talaschian
Street address
Iran, Tehran, North kargar,Shariati Medical, Educational and Medical Center
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 1000
Email
shariatihosp@tums.ac.ir

2

Recruitment center
Name of recruitment center
Shariati Medical, Educational and Medical Center
Full name of responsible person
Dr. Keivan Gohari Moghadam
Street address
Iran - Tehran - North Kargar - Shariati Medical, Educational and Medical Center
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 1000
Email
shariatihosp@tums.ac.ir
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mr. Dr. Sahraian
Street address
Keshavarz Boulevard, corner of Quds Street, Central University Organization, sixth floor, Vice Chancellor for Research and Technology نماد «مورد تأیید انجمن»
City
Tehran
Province
Tehran
Postal code
14155-6117
Phone
+98 21 8163 3685
Email
vcr@tums.ac.ir
Web page address
http://en.tums.ac.ir/en
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Keianoush Karami
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Faculty of Nutrition and Dietetics, University of Medical Sciences and Health Services, Tehran, Keshavarz Blvd., Naderi St., Hojjatdoost Alley, No. 44
City
Tehran
Province
Tehran
Postal code
3439123900
Phone
+98 21 8895 5975
Email
kianoushkarami91@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Hossein Imani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Faculty of Nutrition and Dietetics, University of Medical Sciences and Health Services, Tehran, Keshavarz Blvd., Naderi St., Hojjatdoost Alley, No. 44
City
Tehran
Province
Tehran
Postal code
3439123900
Phone
+98 21 8895 5975
Email
h-imani@sina.tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Keianoush Karami
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Faculty of Nutrition and Dietetics, University of Medical Sciences and Health Services, Tehran, Keshavarz Blvd., Naderi St., Hojjatdoost Alley, No. 44
City
Tehran
Province
Tehran
Postal code
3439123900
Phone
+98 21 8895 5975
Email
kianoushkarami91@gmail.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
Yes - There is 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 information can be shared two months after the results are published.
When the data will become available and for how long
Two months after the publication of the results
To whom data/document is available
Doctors, nutritionists and nurses
Under which criteria data/document could be used
To evaluate other complementary therapies and compare its effect with existing therapies related to COVID-19 disease
From where data/document is obtainable
Send email to kianoushkarami91@gmail.com
What processes are involved for a request to access data/document
Two months after the publication of the results, send a written request by e-mail to kianoushkarami91@gmail.com. In this case, and finally up to one month after receiving the email, the request will be answered.
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