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IRCT20210702051763N1 IRCT 2021-08-14 Bandare-abbas University of Medical Sciences The effect of vitamin D and magnesium supplementation on patients with COVID-19 The effect of vitamin D and magnesium supplementation on clinical symptoms, inflammatory markers and oxidative stress in patients with COVID-19: double-blind randomized control clinical trial 2021-08-23 anticipated 104 Complete https://irct.ir/trial/57413 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Factorial, Purpose: Treatment, Randomization description: In this study, a random block design will be used for randomization. In this way, 24 blocks of 4 will be made using codes A, B, C, and D that these blocks will be numbered from 1 to 24 (ABCD, ACBD, ABDC, ADBC, ACDB, ADCB, BACD, BCAD, BADC, BDAC, BCDA, BDCA, CABD, CBAD, CADB, CDAB, CBDA, CDBA, DABC, DBAC, DACB, DCAB, DBCA, DCBA) and then using R software, twenty-six blocks from blocks 1 to 24 are randomly selected, Blinding description: Vitamin D supplement and placebo will be provided by Zahravi Pharmaceutical Company (Iran). Magnesium placebo will be made from starch with the same color and shape as the magnesium supplement by the Faculty of Pharmacy of Hormozgan University of Medical Sciences. In this study, blinding of participants, staff, and investigators will be done (Magnesium and Vitamin D supplements and placebos will be placed in the same package with codes of A, B, C, and D by a responsible person who is not aware of the study objectives. The codes will not be available to researchers until after statistical analysis. In order to blind the participants, they will be explained at the beginning of the study who will receive one of four types of intervention and will not be told the exact type of supplement. 3 COVID-19. Intervention 1: vitamin D supplement (two 50,000 IU capsules at the beginning of the study, two 50,000 IU capsules on the 4th day, one 50,000 IU capsule on the 11th day, and one 50,000 IU capsule on the 17th day) and magnesium supplement (300 mg/day). Intervention 2: vitamin D (two 50,000 IU capsules at the beginning of the study, two 50,000 IU capsules on the 4th day, one 50,000 IU capsule on the 11th day, and one 50,000 IU capsule on the 17th day) and magnesium placebo. Intervention 3: Magnesium supplement (300 mg/day) and vitamin D placebo. Intervention 4: Vitamin D placebo and magnesium placebo. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no more information
public Nahid Ramezani-Jolfaie
Imam Hussein Blvd, Campus of Medical Sciences
Bandar Abbas Iran (Islamic Republic of) 7919693116 +98 76 3371 0370 ramezani.n.j@gmail.com Bandare-abbas University of Medical Sciences scientific Nahid Ramezani-Jolfaie
Imam Hussein Blvd, Campus of Medical Sciences
Bandar Abbas Iran (Islamic Republic of) 7919693116 +98 76 3371 0370 ramezani.n.j@gmail.com Bandare-abbas University of Medical Sciences Iran (Islamic Republic of) People aged 18-65 confirmation of Covid-19 infection by RT-PCR test completing informed consent less than 48 hours have passed since the patient was hospitalized no skin or gastrointestinal allergies due to taking multivitamin supplements, vitamin D, and magnesium people with more than 30 breaths per minute and less than 93% oxygen saturation in room air and sea level. 18 years 65 years Both Pregnancy or lactation take a daily multivitamin or take a vitamin D or magnesium supplement in the last month participating in other clinical studies renal failure or dialysis, severe liver disease or cirrhosis known diagnosis of hypercalcemia patients who discharged from the hospital less than 24 hours after the start of the intervention history of kidney stones in the last year transfer the patient to the ICU baseline vitamin D levels above 80 ng/ml baseline magnesium levels above 2.6 mg/dl. U07.1 COVID-19 Treatment - Drugs Treatment - Drugs Treatment - Drugs Placebo vitamin D supplement (two 50,000 IU capsules at the beginning of the study, two 50,000 IU capsules on the 4th day, one 50,000 IU capsule on the 11th day, and one 50,000 IU capsule on the 17th day) and magnesium supplement (300 mg/day). vitamin D (two 50,000 IU capsules at the beginning of the study, two 50,000 IU capsules on the 4th day, one 50,000 IU capsule on the 11th day, and one 50,000 IU capsule on the 17th day) and magnesium placebo Magnesium supplement (300 mg/day) and vitamin D placebo Vitamin D placebo and magnesium placebo Myalgia. Timepoint: at baseline and at the end of study (3 weeks later). Method of measurement: to be or not to be. Fever. Timepoint: at baseline and at the end of study (3 weeks later). Method of measurement: to be or not to be. Dry cough. Timepoint: at baseline and at the end of study (3 weeks later). Method of measurement: to be or not to be. Shortness of breath. Timepoint: at baseline and at the end of study (3 weeks later). Method of measurement: to be or not to be. Percentage of oxygen saturation. Timepoint: at baseline and at the end of study (3 weeks later). Method of measurement: Oxygen meter. WBC. Timepoint: at baseline and at the end of study (3 weeks later). Method of measurement: Laboratory tests. CRP. Timepoint: at baseline and at the end of study (3 weeks later). Method of measurement: Laboratory tests. MDA. Timepoint: at baseline and at the end of study (3 weeks later). Method of measurement: Laboratory tests. TAC. Timepoint: at baseline and at the end of study (3 weeks later). Method of measurement: Laboratory tests. Headache. Timepoint: at baseline and at the end of study (3 weeks later). Method of measurement: to be or not to be. Mortality. Timepoint: at baseline and at the end of study (3 weeks later). Method of measurement: number. Neutrophil count. Timepoint: at baseline and at the end of study (3 weeks later). Method of measurement: number. Lymphocyte count. Timepoint: at baseline and at the end of study (3 weeks later). Method of measurement: number. The ratio of neutrophils to lymphocytes. Timepoint: at baseline and at the end of study (3 weeks later). Method of measurement: Percentage. 25 hydroxyvitamin D. Timepoint: at baseline and at the end of study (3 weeks later). Method of measurement: Nanograms per milliliter. Magnesium. Timepoint: at baseline and at the end of study (3 weeks later). Method of measurement: milligram per deciliter. Bandare-abbas University of Medical Sciences Approved 2021-05-30 Research Ethics Committees of Hormozgan University of Medical Sciences Imam Hussein Blvd, Campus of Medical Sciences Bandar Abbas Hormozgan Iran (Islamic Republic of)