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IRCT20151226025699N5 IRCT 2021-04-07 Sabzevar University of Medical Sciences The effect of vitamin A, B, C, D, and E supplementations in COVID-19 The effect of vitamin A, B, C, D, and E supplementations on biochemical parameters of critically ill patients with COVID-19: A randomized clinical trial 2021-04-21 anticipated 135 Complete https://irct.ir/trial/55074 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Allocation will be done to two intervention and control groups by simple random sampling with individual randomization unit through the web-based application (https://www.randomizer.org). One of the members of the researcher team that not involved in the selection of samples, will determine the random allocation sequence using a computer program. Randomization tools are sealed non-transparent envelopes that used in random sequences to hide the allocation, Blinding description: This research is done in the 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 vitamin A, B, C, D, and E supplementations in this study. vitamin A, B, C, D, and E supplementations are added after 24 hours of hospitalization in the ICU for 20 days by a nurse, who is not on the research team, with a needle from supplementation 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. 2-3 COVID-19. Intervention 1: The intervention group in addition to receiving routine ICU medications according to the national protocol, which includes hydroxychloroquine sulfate, chloroquine phosphate, kaletra (lupinavir / ritonavir), ribavirin and atazanavir / ritonavir, will receive vitamin A, B, C, D, and E supplementations from HAKIM Vitakim Pharmaceutical Company including vitamin A (50,000 doses per week), B complex (including 10 mg of vitamin B1, 4 mg of vitamin B2, 4 mg of vitamin B6, 40 mg of nicotinamide and 6 mg of dexpanthenol daily), C (dose 500 mg daily), D (50,000 daily dose) and E (100 mg daily dose) for 20 days through intestinal formula in the form of gavage. Intervention 2: The control group like the intervention group, receive routine ICU medications according to the national protocol, which includes hydroxychloroquine sulfate, chloroquine phosphate, kaletra (lupinavir / ritonavir), ribavirin and atazanavir / ritonavir. However, unlike them, no specific intervention or activity will be performed in the control group and they only intake the same calorie as the intervention group using the same route. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No more data is available
public Dr. Alireza Moslem
Khorasan Razavi - Sabzevar - Asadabadi St. - Next to Melli garden- Central Headquarters Building - Fourth Floor Office Office
Sabsevar Iran (Islamic Republic of) 9617913114 +98 51 4401 1004 alirezamoslem@gmail.com Sabzevar University of Medical Sciences scientific Dr. Saeid Doaei
Sardare Jangal Boulevard
Rasht Iran (Islamic Republic of) 41448 +98 13 3355 0028 sdoaei@sbmu.ac.ir Rasht University of Medical Sciences Iran (Islamic Republic of) 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 Awareness score of at least 3 based on the 15-point Glasgow Coma Score (GCS) 35 years 85 years Both Not tendency to participate 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 vitamin A, B, C, D, and E supplementations Consumption of vitamin A, B, C, D, and E supplementations during the last 3-month before the study Pregnancy in women U07.1 COVID-19, virus identified Treatment - Drugs Other The intervention group in addition to receiving routine ICU medications according to the national protocol, which includes hydroxychloroquine sulfate, chloroquine phosphate, kaletra (lupinavir / ritonavir), ribavirin and atazanavir / ritonavir, will receive vitamin A, B, C, D, and E supplementations from HAKIM Vitakim Pharmaceutical Company including vitamin A (50,000 doses per week), B complex (including 10 mg of vitamin B1, 4 mg of vitamin B2, 4 mg of vitamin B6, 40 mg of nicotinamide and 6 mg of dexpanthenol daily), C (dose 500 mg daily), D (50,000 daily dose) and E (100 mg daily dose) for 20 days through intestinal formula in the form of gavage. The control group like the intervention group, receive routine ICU medications according to the national protocol, which includes hydroxychloroquine sulfate, chloroquine phosphate, kaletra (lupinavir / ritonavir), ribavirin and atazanavir / ritonavir. However, unlike them, no specific intervention or activity will be performed in the control group and they only intake the same calorie as the intervention group using the same route. White blood cells (WBCs). Timepoint: Baseline, 20-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, 20-day after intervention. Method of measurement: using standard kits and the researchers gather these information from the lab test section of the ICU sheets. Lymphocytes. Timepoint: Baseline, 20-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, 20-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, 20-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, 20-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, 20-day after intervention. Method of measurement: using standard kits and the researchers gather these information from the lab test section of the ICU sheets. Partial pressure of oxygen (PO2). Timepoint: Baseline, 20-day after intervention. Method of measurement: using standard kits and the researchers gather these information from the lab test section of the ICU sheets. Partial pressure of carbon dioxide. Timepoint: Baseline, 20-day after intervention. Method of measurement: using standard kits and the researchers gather these information from the lab test section of the ICU sheets. Rasht University of Medical Sciences Sabzevar University of Medical Sciences Rasht university of medical sciences Approved 2021-03-15 Ethics committee of Sabsevar university of Medical sciences and Health services Asad Abadi street Sabzevar Razavi Khorasan Iran (Islamic Republic of)