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The effect of omega-3 supplementation on inflammatory and biochemical markers in critical ill patients with COVID-19 a randomized clinical trial

Protocol summary

Study aim
Determining of the effect of omega-3 supplementation on inflammatory and biochemical markers in critical ill patients with COVID-19
Design
A randomized clinical trial study, triple-blind trial, fifty critical ill patients infected with COVID-19 undergoing respiratory and nutritional supports, Intervention and control groups through web-based randomization using https://www.randomizer.org, Twenty-five patients as the intervention group and other 25 patients as the control group.
Settings and conduct
we will attend at ICU of Razi hospital in Rasht, Iran, and complete the consent form, information will be required using these questionnaires: Medical history, Anthropometric measurement, Dietary intake, Biochemical & inflammatory indices (at baseline and after 14 days).
Participants/Inclusion and exclusion criteria
This study will be done on fifty critical ill patients with COVID-19 who are undergoing respiratory and nutritional supports in Razi hospital of Rasht, and enter to the study in the two intervention and control groups through simple randomized selection by web-based randomization.
Intervention groups
The intervention group will receive one capsule of omega-3 daily, produced by Omid persina damavand company, Iran (1000 mg Omega-3 for each capsule, containing of EPAs+DHAs), through adding supplement to the intestinal formula in the form of gavage. Specific intervention or activity don’t perform in the control group and they only intake the same calorie as the intervention group using the same rout.
Main outcome variables
WBC, Neutrophils, Lymphocytes, LDH, CPK, CBC, CRP

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20151226025699N3
Registration date: 2020-05-20, 1399/02/31
Registration timing: prospective

Last update: 2020-05-20, 1399/02/31
Update count: 0
Registration date
2020-05-20, 1399/02/31
Registrant information
Name
Saeid Doaei
Name of organization / entity
National Nutrition and Food Technology Research Institute
Country
Iran (Islamic Republic of)
Phone
+98 21 6643 6744
Email address
sdoaei@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-04, 1399/03/15
Expected recruitment end date
2020-06-18, 1399/03/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of omega-3 supplementation on inflammatory and biochemical markers in critical ill patients with COVID-19 a randomized clinical trial
Public title
The effect of omega-3 supplementation in COVID-19
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Written consent for participation Age over 34 years A diagnosis of COVID-19 based on symptoms such as severe pneumonia, fever, fatigue, dry cough, respiratory distress, and lungs involvement in the computed tomographic (CT) scan according to the doctor's confirmation
Exclusion criteria:
Not tendency to continue participating in the study Diagnosed cardiovascular and lung diseases which can disturb the study process A diagnosis of malignant tumors Recent use of chemotherapy drugs Having incomplete medical records Non-compliance with the omega-3 supplementation Consumption of omega-3 fatty acids supplementation during the last 3-month before the study
Age
From 35 years old to 85 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: 50
Randomization (investigator's opinion)
Randomized
Randomization description
Critical ill patients with COVID-19 who are undergoing respiratory and nutritional supports, will be assigned to the two intervention and control groups through simple individual randomized sampling by web-based randomization (randomizer.org). One of the researcher team determines the randomized allocation sequence using the computer program. The sealed non-transparent envelopes with randomized sequence will be used to hide the allocation.
Blinding (investigator's opinion)
Triple blinded
Blinding description
This research is done in triple-blind method; This means that none of the patients, researchers and statistical analysts know the study arms. The patients in the study were not aware of the use or non-use of omega-3 supplements in this study. Omega-3 fatty acids are added by a nurse, who is not on the research team, with a needle from omega-3 capsules to the gavage formula of the individuals in the case group, which has been informed confidential about them. The results are evaluated by a person outside the treatment team.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Sabsevar university of Medical sciences and Health services
Street address
Asad abadi street
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913112
Approval date
2020-05-17, 1399/02/28
Ethics committee reference number
IR.MEDSAB.REC.1399.054

Health conditions studied

1

Description of health condition studied
COVID-19
ICD-10 code
U07.1
ICD-10 code description
COVID-19, virus identified

Primary outcomes

1

Description
White blood cells (WBCs)
Timepoint
Baseline, 14-day after intervention
Method of measurement
using standard kits and the researchers gather these information from the lab test section of the ICU sheets.

2

Description
Neutrophils
Timepoint
Baseline, 14-day after intervention
Method of measurement
using standard kits and the researchers gather these information from the lab test section of the ICU sheets.

3

Description
Lymphocytes
Timepoint
Baseline, 14-day after intervention
Method of measurement
using standard kits and the researchers gather these information from the lab test section of the ICU sheets.

4

Description
Lactate dehydrogenase (LDH)
Timepoint
Baseline, 14-day after intervention
Method of measurement
using standard kits and the researchers gather these information from the lab test section of the ICU sheets.

5

Description
Creatine phosphokinase (CPK)
Timepoint
Baseline, 14-day after intervention
Method of measurement
using standard kits and the researchers gather these information from the lab test section of the ICU sheets.

6

Description
Cell blood count (CBC)
Timepoint
Baseline, 14-day after intervention
Method of measurement
using standard kits and the researchers gather these information from the lab test section of the ICU sheets.

7

Description
C reactive protein
Timepoint
Baseline, 14-day after intervention
Method of measurement
using standard kits and the researchers gather these information from the lab test section of the ICU sheets.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group daily receive one capsule of omega-3 produced by Omid persina damavand company, Iran (1000 mg Omega-3 for each capsule, containing of EPAs+DHAs), through adding supplement to the intestinal formula in the form of gavage.
Category
Treatment - Drugs

2

Description
Specific intervention or activity don’t perform in the control group and they only intake the same calorie as the intervention group using the same rout.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Razi hospital
Full name of responsible person
Siamak Rimaz
Street address
RaziSardare Jangal Boulevard
City
Tehran
Province
Guilan
Postal code
41448
Phone
+98 13 3355 0028
Email
sdoaee@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Dr. Alireza Moslem
Street address
Asad abadi street
City
Sabsevar
Province
Razavi Khorasan
Postal code
9617913112
Phone
+98 51 4401 1000
Email
info@medsab.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Sabsevar university of medical sciences
Proportion provided by this source
50
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

2

Sponsor
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Dr. Arsalan salari
Street address
Parastar Street
City
Rasht
Province
Guilan
Postal code
41887-94755
Phone
+98 13 3334 6489
Email
salari@gums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Rasht university of medical sciences
Proportion provided by this source
50
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
Sabzevar University of Medical Sciences
Full name of responsible person
Dr. Alireza Moslem
Position
Anesthesiologist
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Khorasan Razavi - Sabzevar - Asadabadi St. - Next to Melli garden- Central Headquarters Building - Fourth Floor Office Office
City
Sabsevar
Province
Razavi Khorasan
Postal code
9617913114
Phone
+98 51 4401 1004
Email
alirezamoslem@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Saeid Doaei
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Sardare Jangal Boulevard
City
Rasht
Province
Guilan
Postal code
41448
Phone
+98 13 3355 0028
Email
sdoaei@sbmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Saeid Doaei
Position
دکترای تخصصی
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Shahid Beheshti University of Medical Sciences, Tehran, IRAN.
City
Tehran
Province
Tehran
Postal code
009821
Phone
+98 21 6643 6744
Email
sdoaei@sbmu.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be 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
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