Assessing the effect of Astaxanthin Phytochemical, Vitamin D3, Omega-3 and Vitamin E سupplement on the severity of COVID-19 Symptoms of Patients with mild to Moderate Severity- a randomized double blind controlled Clinical Trial

Determining the effects of Astaxanthin , Vitamin D3, Omega-3 and Vitamin E supplement on the severity of COVID-19 in patients with mild to moderate COVID-19

Randomized double blind controlled trial phase 2 with a parallel group design of 40 patients, randomized using random digit table

This double blinded study will be performed in Fayaz Bakhsh Hospital. At base line and after 7 days of intervention with supplement/placebo, patients will be assessed by general physician for respiratory rate, heart rate, O2 saturation, fever, anosmia, and headache. At baseline and at the end of the study total lymphocyte and notrophil count, ESR, CRP& ferritin will be evaluated. Samples will be collected for assessing IL-6 and TNF-α at baseline and at the end of the study and will be stored in -70 degree till the time of assessment. Data will be analyzed using SPSS 21.

Inclusion criteria: Positive test for COVID-19 according to World Health Organization criteria and diagnosed with COVID-19 of mild to moderate severity Willingness to participate in the project age>18 years Exclusion criteria: Diagnosed with severe COVID-19 Pregnancy Using Omega-3 and/or vitamin E in 2 months before study initiation Vitamin D deficiency Enteral or parenteral nutrition need Need for Intensive Care Unit admission

Patients will receive Astaxanthin Phytochemical, Vitamin D3, Omega-3 and Vitamin E capsule or placebo BD for 7 days. Each capsule contains 20 mg Astaxanthin, 200 mg omeg-3, 30 mg vitamin E, and 1000 IU vitamin D in intervention group or maltodextrine in placebo group.

Effect of above mentioned supplement on O2 saturation, IL-6 and TNF-α

Participants will have equal chance to be assigned to studied groups. We will use random digits table to make random sequence. After determining the first number, we will continue downward and allocate even numbers to cases and odd numbers to placebo. As in small sample sizes, it would be probable that one group be completed earlier, if one group completed earlier, we will allocate the other assigned numbers to other group. A person out of study group will put her figure on one digit of the table with closed eyes and according to assumed agreement will go downward through the table and write the numbers down until completing the sample size in each group. Code "A" will allocated to even numbers and considered as "intervention group" and code "B" will allocated to odd numbers and considered as "placebo group". At the end we will have the sequence of 40 specific numbers and A&B codes. A person out of study team will put the numbers in sealed packets till the time of sampling

It is a double blind study. A third person out of study team have the sequence of codes that provide the team with sealed pockets containing allocation code at the time of sampling. The following groups of people involved in the trial: participants, Research team including principle investigator, data collectors, and outcome assessors will be blind.

All data would be available to public

starting 6 months after publication

To all

No other critaria

Email to soodehrazeghi@gmail.com

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