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IRCT20140804018677N9 IRCT 2021-06-19 Shahid Beheshti University of Medical Sciences Effect of Astaxanthin Phytochemical, Vitamin D3, Omega-3 and Vitamin E supplement on severity of mild to moderate COVID-19 Symptoms 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 2021-05-28 anticipated 40 Complete https://irct.ir/trial/56509 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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, Blinding description: 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. 3 Covid-19. Intervention 1: Intervention group: 20 mg Astaxanthin, 200 mg omeg-3, 30 mg vitamin E, and 1000 IU vitamin D per cap for 7 days, BD. Intervention 2: Control group: placebo containing maltodextrine-for 7 days. Yes - There is a plan to make this available What will be shared: All data would be available to public When: starting 6 months after publication To whom: To all Conditions: No other critaria Where to obtain: Email to soodehrazeghi@gmail.com How to obtain: sending email Comments:
public Soodeh Razeghi Jahromi
No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town,
Tehran Iran (Islamic Republic of) 1981619573 +98 21 2235 7483 soodehrazeghi@gmail.com Shahid Beheshti University of Medical Sciences scientific Soodeh Razeghi Jahromi
No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town
Tehran Iran (Islamic Republic of) 1981619537 +98 21 2235 7483 soodehrazeghi@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Positive test for COVID-19 according to WHO criteria and diagnosed with COVID-19 of mild to moderate severity Willingness to participate in the project age>18 years 18 years no limit Both Diagnosed with severe COVID-19 according to WHO criteria Pregnancy Using Omega-3 and/or vitamin E in 2 months before study initiation Vitamin D deficiency PN or EN need Need for ICU admission U07.1 COVID-19, virus identified Treatment - Drugs Treatment - Drugs Intervention group: 20 mg Astaxanthin, 200 mg omeg-3, 30 mg vitamin E, and 1000 IU vitamin D per cap for 7 days, BD Control group: placebo containing maltodextrine-for 7 days Respiratory rate. Timepoint: baseline and at the end of the study. Method of measurement: pulsoximeter. Pulse rate. Timepoint: baseline and at the end of the study. Method of measurement: Wrist radial atrial pulse. Interlukin-6. Timepoint: baseline and at the end of the study. Method of measurement: ELISA. Tumor necrotising factor alpha. Timepoint: baseline and at the end of the study. Method of measurement: ELISA. Shahid Beheshti University of Medical Sciences Approved 2020-09-27 Ethics committee of National Nutrition and Food Technology Reseach Institute No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town Tehran Tehran Iran (Islamic Republic of)