Evidence for the Efficacy of a High Dose of Vitamin D on the Hyperinflammation State in Moderate-to-Severe COVID-19 Patients: A Randomized Clinical Trial
Neven Sarhan, Ahmed E Abou Warda, Rania M Sarhan, Marian S Boshra, Gomaa Mostafa-Hedeab, Bashayer F Alruwaili, Haytham Soliman Ghareeb Ibrahim, Mona F Schaalan, Shaimaa Fathy
Medicina, doi:10.3390/medicina58101358
Background and Objectives: Vitamin D supplementation plays a key effect in lowering cytokine storms among COVID-19 patients by influencing the activity of the renin-angiotensin system and the production of the angiotensin-2 converting enzyme. The study was conducted to explore the effect of high-dose intramuscular vitamin D in hospitalized adults infected with moderate-tosevere SARS-CoV-2 in comparison with the standard of care in the COVID-19 protocol. Materials and Methods: Two groups of patients were compared in this prospective randomized controlled trial as the vitamin D was administered orally to group 1 (alfacalcidol 1 mcg/day) and intramuscularly to group 2 (cholecalciferol 200,000 IU). One hundred and sixteen participants were recruited in total, with fifty-eight patients in each group. Following the Egyptian Ministry of Health's policy for COVID-19 management, all patients received the same treatment for a minimum of five days. Results: A significant difference was recorded in the length of hospital stay (8.6 versus 6.8 days), need for high oxygen or non-invasive mechanical ventilator (67% versus 33%), need for a mechanical ventilator (25% versus 75%), clinical improvement (45% versus 55%), the occurrence of sepsis (35% versus 65%), and in the monitored laboratory parameters in favor of high-dose vitamin D. Moreover, clinical improvement was significantly associated with the need for low/high oxygen, an invasive/noninvasive mechanical ventilator (MV/NIMV), and diabetes, while mortality was associated with the need for MV, ICU admission, atrial fibrillation, chronic obstructive pulmonary disease, asthma, and the occurrence of secondary infection. Conclusions: Our study showed that high-dose vitamin D was considered a promising treatment in the suppression of cytokine storms among COVID-19 patients and was associated with better clinical improvement and fewer adverse outcomes compared to low-dose vitamin D.
Predictors of Clinical Improvement by Binary Logistic Regression Analysis The binary logistic regression analysis indicated that better clinical improvement and less severe COVID-19 symptoms were associated with the need for low oxygen (OR = 6.67, C.I. = 2.07-21.35, p = 0.001) and inversely associated with the need for high oxygen and NIMV (OR = 6.19, C.I. = 0.41-0.86, p = 0.031), the need for an invasive mechanical ventilator (MV) (OR = 0.83, C.I. = 0.64-0.98, p = 0.012), diabetes (OR = 0.37, C.I. = 0.33-0.56, p = 0.045), atrial fibrillation (OR = 0.41, C.I.= 0.15-0.38, p = 0.008), and the occurrence of secondary infection (OR = 0.33, C.I. = 0.16-0.94, p = 0.004), as shown in Table 3 . However, after conducting a multiple logistic regression with covariates reporting a p-value less than 0.2 in the univariate regression analysis, only the need for low oxygen (adjusted OR = 5.53, C.I. = 2.41-15.12, p = 0.005), the need for high oxygen/NIMV (adjusted OR = 0.23, C.I. = 0.31-0.78, p = 0.041), the need for invasive MV (adjusted OR= 0.71, C.I. = 0.58-0.81, p = 0.038), diabetes (adjusted OR = 0.42, C.I. = 0.28-0.74, p = 0.048), and the occurrence of secondary bacterial infection (adjusted OR = 0.46, C.I.= 0.31-0.83, p = 0.02) remained significant, as shown in Table 4 .
Predictors of Mortality by Binary Logistic Regression Analysis The binary logistic regression analysis revealed that COVID-19 mortality was associated with the need for MV (OR = 4.93, C.I. = 1.1-12.56, p = 0.039),..
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'abstract': '<jats:p>Background and Objectives: Vitamin D supplementation plays a key effect in lowering '
'cytokine storms among COVID-19 patients by influencing the activity of the renin-angiotensin '
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'explore the effect of high-dose intramuscular vitamin D in hospitalized adults infected with '
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