The effect of omega-3 supplementation in COVID-19

• Register: IRCT
• Last refreshed on: 15 June 2020
• Main ID: IRCT20151226025699N3
• Date of registration: 2020-05-20
• Prospective Registration: Yes
• Primary sponsor: Sabzevar University of Medical Sciences
• Public title: The effect of omega-3 supplementation in COVID-19
• Scientific title: The effect of omega-3 supplementation on inflammatory and biochemical markers in critical ill patients with COVID-19 a randomized clinical trial
• Date of first enrolment: 2020-06-04
• Target sample size: 50
• Recruitment status: Recruiting
• URL: http://en.irct.ir/trial/48213
• Study type: interventional
• Study design: Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, 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 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 indi
• Phase: N/A

Countries of recruitment

Iran (Islamic Republic of)

Contacts

• Name: Dr. Alireza Moslem
• Affiliation: Sabzevar University of Medical Sciences

• Name: Saeid Doaei
• Affiliation: Guilan University of Medical Sciences

Key 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 minimum: 35 years
Age maximum: 85 years
Gender: Both

Health Condition(s) or Problem(s) studied

COVID-19.
COVID-19, virus identified

U07.1

Intervention(s)

Intervention 1: 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. Intervention 2: 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.

Primary Outcome(s)

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.

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.

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.

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.

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.

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.

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.

Source(s) of Monetary Support

Sabsevar university of medical sciences

Rasht university of medical sciences

Secondary Sponsor(s)

Rasht University of Medical Sciences

Ethics review

Status: Approved
Approval date: 17/05/2020
Contact:

Ethics committee of Sabsevar university of Medical sciences and Health services