A randomized pilot study using calcitriol in hospitalized COVID-19 patients

Abstract

The systemic illness associated with SARS-CoV-2 infection results in hospitalization rate of 380.3 hospitalizations per 100,000 population, overwhelming health care systems. Vitamin D regulates expression of approximately 11,000 genes spanning many physiologic functions that include regulation of both innate and adaptive immune function. We investigate potential benefit of calcitriol therapy given to patients hospitalized with COVID-19. This was an open label, randomized clinical trial of calcitriol or no treatment given to hospitalized adult patients with COVID-19. Subjects were randomly assigned treatment with calcitriol 0.5 mcg daily for 14 days or hospital discharge; or no treatment [ 1 : 1 ] at time of enrollment. We enrolled 50 consecutive patients, 25 per trial arm. The change in peripheral arterial oxygen saturation to the inspired fraction of oxygen (SaO2/FIO2 ratio) on admission and discharge between the groups the control group had an average increase of +13.2 (+/- 127.7) on discharge and the calcitriol group had an increase of +91.04 (+/- 119.08) (p= .0305), suggesting an improvement in oxygenation among subjects who received calcitriol. Additionally, 12 patients in the control group required oxygen supplementation on admission and 21 of them were discharged on room air. 14 subjects needed oxygen supplementation in the calcitriol group on admission while all 25 were discharged on room air. Other clinical markers showed the average length of stay was 9.24 (± 9.4) in the control group compared to 5.5 (± 3.9) days in the calcitriol group (p= .14). The need for ICU transfer was 8 in the control group and 5 in the calcitriol group. There were 3 deaths and 4 readmissions in the control group and 0 deaths and 2 readmissions in the calcitriol group. This pilot study illustrates improvement in oxygenation among hospitalized patients with COVID-19 treated with calcitriol and suggests the need for a larger randomized trial.

Therapeutic Vitamin D Supplementation Following COVID-19 Diagnosis: Where Do We Stand?—A Systematic Review

“…The literature search yielded a total of 1376 articles (832 on PubMed and 544 on Scopus), among which 189 were selected to be evaluated as full texts. Finally, a total of 11 [ 25 , 28 , 29 , 30 , 31 , 32 , 33 , 34 , 35 , 36 , 37 ] articles fully met our inclusion criteria and were included in this systematic review ( Figure 1 ).…”

“…The studies were published from October 2020 to September 2021 and were conducted in four different continents. Three studies took place in Spain [ 31 , 33 , 34 ] and one in each of the following countries: France [ 28 ], USA [ 32 ], Brazil [ 35 ] Turkey [ 30 ], Singapore [ 36 ], Saudi Arabia [ 29 ], India [ 25 ] and Egypt [ 37 ]. The majority [ 25 , 28 , 30 , 31 , 33 , 36 , 37 ] were single-center, while in four studies patients from two [ 35 ], three [ 29 , 32 ] or five [ 34 ] centers were recruited.…”

“…Three studies took place in Spain [ 31 , 33 , 34 ] and one in each of the following countries: France [ 28 ], USA [ 32 ], Brazil [ 35 ] Turkey [ 30 ], Singapore [ 36 ], Saudi Arabia [ 29 ], India [ 25 ] and Egypt [ 37 ]. The majority [ 25 , 28 , 30 , 31 , 33 , 36 , 37 ] were single-center, while in four studies patients from two [ 35 ], three [ 29 , 32 ] or five [ 34 ] centers were recruited. Our study collection includes four randomized controlled trials [ 29 , 32 , 33 , 35 ], one non-randomized controlled trial [ 28 ] and six observational cohort studies [ 25 , 30 , 31 , 34 , 36 , 37 ], among which two [ 25 , 31 ] were reported as prospective and three [ 34 , 36 , 37 ] as retrospective.…”

“…Seven of them investigated the effect of vitamin D 3 (cholecalciferol), administered daily per os [ 29 , 36 ], as a high single oral dose of 60,000 IU [ 25 ], 80,000 IU [ 28 ] or 200,000 IU [ 35 ] or as an intramuscular injection of 200,000 [ 37 ] or 300,000 IU [ 30 ]. Three studies [ 31 , 33 , 34 ] applied various regimens of oral 25(OH)D3 (calcifediol) and one trial [ 32 ] used oral 1,25(OH) 2 D 3 (calcitriol) at 0.5μg/day for 14 days.…”

Effects of environmental parameters and their interactions on the spreading of SARS-CoV-2 in North Italy under different social restrictions. A new approach based on multivariate analysis

“…Although these investigations have shown interesting results, the number of enrolled individuals is small. Therefore, no definitive conclusions may be drawn and further trials are needed to clarify this topic ( Entrenas Castillo et al, 2020 ; Elamir et al, 2021 ).…”