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IRCT20210102049912N1 IRCT 2021-04-07 Arak University of Medical Sciences The effect of vitamin A supplementation in outpatients with COVID-19 Comparing the effect of standard treatment with and without vitamin A supplementation in improving the clinical symptoms of outpatients with COVID-19 2021-04-09 anticipated 140 Complete https://irct.ir/trial/53693 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, randomization is performed using block generation method and Random Allocation software. Random Allocation software provides a table of 140 in which our two groups, groups A and B, are each repeated 70 times randomly to minimize the possibility of biased intervention. Each cell in this table is called a block. There will be one patient in each block and the therapist will refer the patients who meet the inclusion criteria to the pharmacy and the patients will be placed in the random blocks of the above table, respectively, Blinding description: This study will be a double-blind study using placebo. Therefore, in order to blind in this study, patients, laboratory technicians, therapist who will be responsible for the activity of prescribing drugs, receiving samples and completing a questionnaire, as well as the researcher responsible for evaluating the results and statistical analyzer will be blind to patient allocation, and will not know which patient is in the intervention and which patient is in the control group. The main researcher will not be blind to the groups and will prepare the drugs and placebo in two packages A and B and place them in the pharmacy with the pharmacist. 3 COVID-19. Intervention 1: Intervention group: In the intervention group, in addition to receiving the national standard treatment, patients will receive oral vitamin A 25,000 international units (Zahravi-Iran) per day for 10 days. Intervention 2: Control group: In the control group, patients receive only the national standard treatment with an oral placebo similar to the main drug, once a day for 10 days. Yes - There is a plan to make this available What will be shared: All data When: from 2021 To whom: Researchers working in academic and scientific institutions Conditions: Therefore, obtaining permission for all processes is free Where to obtain: Arak University of Medical Sciences How to obtain: Email the researcher and receive the file. Comments:
public Mehdi Shokri
Payambar-e-azam Complex, Sardasht Town
Arak Iran (Islamic Republic of) 3848176941 +98 86 3417 3630 dr_mehdi75@yahoo.com Arak University of Medical Sciences scientific Mehdi Shokri
Payambar-e-azam Complex, Sardasht Town
Arak Iran (Islamic Republic of) 3848176941 +98 86 3417 3630 dr_mehdi75@yahoo.com Arak University of Medical Sciences Iran (Islamic Republic of) Having clinical signs and test results that confirm COVID-19 CRP level higher than 0.3 mg per liter Having an ESR higher than 22 mm per hour for women and 29 mm per hour for men 15 years 75 years Both Having any autoimmune disease (lupus, MS, etc.) Suffering from diseases that interfere with the absorption of vitamin A. Consumers of vitamin A supplements Patients with severe renal insufficiency and dialysis Patients with underlying liver disease Pregnancy Lactation U07.1 COVID-19, virus identified Treatment - Drugs Placebo Intervention group: In the intervention group, in addition to receiving the national standard treatment, patients will receive oral vitamin A 25,000 international units (Zahravi-Iran) per day for 10 days. Control group: In the control group, patients receive only the national standard treatment with an oral placebo similar to the main drug, once a day for 10 days. Clinical symptoms improvement. Timepoint: Before the intervention and 10 days after the start of the intervention. Method of measurement: Definition of clinical improvement includes normalization of body temperature (≤37.2's,) number of breaths (≤ 24 breaths per minute,) oxygen saturation (> 94% at room temperature) that is stable for at least 24 hours. Hospitalization. Timepoint: Ten days after the start of the intervention. Method of measurement: Patients' hospitalization will be recorded using a questionnaire and their follow-up. C-reactive protein. Timepoint: Before the intervention and 10 days after the intervention. Method of measurement: Hemagglutination. Erythrocyte Sedimentation Rate. Timepoint: Before the intervention and 10 days after the intervention. Method of measurement: Erythrocyte Sedimentation test. Arak University of Medical Sciences Approved 2020-07-25 Ethics Committee of Arak University of Medical Sciences Payambar-e-azam Complex, Sardasht Town Arak Markazi Iran (Islamic Republic of)